AsthmaPhase 1NCT04032834

A Comparison of VR647 and Conventionally Nebulized Budesonide in Healthy Volunteers and Adult Asthma Subjects

A Phase 1 study testing VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask and 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece in people with Asthma, run by Vectura Limited at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask and 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesUnited States
Study dates: 20 Feb 2017to 22 May 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subject
Female subjects must have a negative pregnancy test at the Screening and Day -1 Visits (prior to dosing), must be using a reliable form of contraception throughout the trial, or must be of non-childbearing potential as follows:
Be post-menopausal (their last menstrual period was at least 12 months ago), and have a serum follicle-stimulating hormone (FSH) level consistent with postmenopausal status as determined by the investigator, or
Have undergone a hysterectomy, a bilateral oophorectomy or a bilateral salpingectomy
Aged 18 to 55 years
Hemoglobin level of ≥11.5 g/dL for females and ≥13.0 g/dL for males

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Weigh at least 50 kg, and body mass index (Quetelet index) in the range 18.0-32.0 kg/m2, inclusive
Forced expiratory volume in 1 second (FEV1) of more than 1.69 L at the Screening Visit
Ability to comprehend the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial
Give written consent to participate after reading the consent form, and after having the opportunity to discuss the trial with the investigator or his/her delegate
Additional Inclusion Criteria for Part 3:
Documented clinical history of mild asthma (mild as defined by the National Asthma Evaluation and Prevention Program (NAEPP) guidelines) for at least 6 months before the Screening Visit, but otherwise healthy
FEV1 reversibility (increase of at least 12% and 200 mL in absolute FEV1 from pre bronchodilator value within 15±5 minutes post bronchodilator) at the Screening Visit or during past 12 months
Values for FEV1 of at least 80% of predicted value and normal FEV1/forced vital capacity (FVC; as defined by NAEPP guidelines). Assessment should be performed without treatment with β2-agonists. If a subject's FEV1 is outside that range at the Screening Visit, the test may be repeated once on another day during the Screening Period

Who cannot join

Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the subject (excluding mild asthma in Part 3)
Subjects who have impaired cardiovascular, endocrine, autoimmune, metabolic, neurological, renal, respiratory (excluding mild asthma in Part 3), gastrointestinal, hepatic, hematological or any other system abnormalities
Respiratory tract infection within 4 weeks before the Screening Visit
History of surgery or medical intervention within 6 weeks before the Screening Visit, or planned surgery or medical intervention, that could interfere with the objectives of the trial or the safety of the subject
Regular treatment (more than 1 month duration) with oral or parenteral corticosteroids in the last year prior to the Screening Visit
Use of the following prescription medications within 28 days prior to the first dose:

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corticosteroids by any route, androgenic steroids (e.g., testosterone), ritonavir and similar drugs for HIV prophylaxis, ketoconazole, itraconazole or similar azole anti-fungal drugs and macrolide antibiotics (e.g., erythromycin)
Presence or history of severe adverse reaction to any drug, or sensitivity to components of the trial medication
Use of a prescription or over-the-counter medicine, nutritional and vitamin supplements, with the exception of acetaminophen and hormonal contraceptives, during the 7 days before the first dose of trial medication. For Part 3 only, inhaled short-acting β2-agonists in addition to acetaminophen and hormonal contraceptives are permitted
Participation in another clinical trial of a new chemical entity, new device, or a prescription medicine within the 3 months before dosing, or participation within 5 half-lives of receiving an experimental drug (whichever is longer)
Presence or history of drug or alcohol abuse, or intake of more than 21 units (14 units for women) of alcohol weekly
Evidence of drug abuse on urine testing, or a positive test for alcohol
Current smoker; or ex-smokers who (a) gave up less than 1 year ago, or (b) who have a history of more than 10 pack years. A pack year is calculated as the number of cigarettes per day multiplied by number of years smoked divided by 20
Blood pressure and heart rate at the screening examination outside the ranges 90-140 mmHg systolic, 40-90 mm Hg diastolic, heart rate 40-100 beats/min
Loss of more than 400 mL blood, e.g., as a blood donor, or donation of blood products, during the 3 months before the Screening Visit
Positive test for hepatitis B, hepatitis C, or HIV
History of, or latent, tuberculosis (TB) infection
Evidence of any other clinically significant infection, including bacterial or viral infections
Possibility that the subject will not cooperate with the requirements of the protocol, including effective use of the nebulizer
Employee of the investigational site or the Sponsor, who is directly involved in the trial, or a family member of such a person
Additional Exclusion Criteria for Part 3:
Any life-threatening asthmatic episode in the past
Asthmatic episode or respiratory tract infection requiring systemic steroid treatment or hospitalization 3 months prior to the Screening Visit
Use of inhaled short-acting β2-agonists for > 2 days/week for symptom relief during 28 days prior to the Screening Visit

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Randomized, Open-label, Crossover Trial to Compare the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Delivered by the VR647 Inhalation System (VR647) With Single Doses of Budesonide Delivered by a Conventional Jet Nebulizer in Healthy Adult Volunteers and Adult Asthma Subjects

This is a three part, randomized, open-label, crossover, Phase 1 trial in adults. Parts 1 and 2 will enroll healthy male and female subjects. Part 3 will enroll subjects with mild asthma. This study will assess the pharmacokinetics, safety and tolerability of single doses of budesonide delivered by VR647 Inhalation System (AKITA® JET) with mouthpiece or face mask to single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS®) with mouthpiece or face mask.

Read the detailed description

For all parts of the study, subjects in the VR647 group will receive VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) with either a mouthpiece or a facemask. Similarly, for all parts of the study, subjects in the comparator group will receive approved doses of budesonide (Pulmicort Respules®) delivered by a conventional jet nebulizer (PARI VIOS) with either a mouthpiece or a facemask.

Part 1:

Subjects who fulfill the enrollment criteria will progress to a comparative single dose, 6-treatment, 6-period crossover trial. Subjects will receive 4 dose levels of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) (5, 10, 15 and 25 breaths, with targeted doses of 30, 60, 120 and 240 µg) and 2 dose levels of budesonide delivered by a conventional jet nebulizer (PARI VIOS) (0.5 and 1 mg). There will be a Washout Period between each dose of approximately 48 hours. Each subject will be randomized to treatment.

Part 2:

Following an approximate 7-day washout, the same cohort of subjects from Part 1 will progress to a comparative single dose, 6-treatment, 6-period crossover trial. There will be a Washout Period between each dose of approximately 48 hours. Each subject will be randomized to treatment in a 6-way crossover.

Part 3:

Subjects with mild asthma who fulfill the enrollment criteria (including those criteria specific to Part 3) will progress to a comparative single dose, 4-treatment, 4-period crossover trial conducted at a separate clinic from Parts 1 and 2. There will be a Washout Period between each dose of approximately 48 hours. This part of the trial can start before completion of Parts 1 and 2.

Conditions: Asthma
Being tested: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask, 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Keywords: Asthma, Budesonide, Nebulizer, Pharmacokinetics, AKITA JET
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpieceCombination product
The VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a mouthpiece and dose-specific VR647 Smart Cards designed specifically for this trial.
VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemaskCombination product
The VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a facemask and dose-specific VR647 Smart Cards designed specifically for this trial.
1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceCombination product
Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.
1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskCombination product
Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.
0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceCombination product
Commercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.
0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskCombination product
Commercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.

Study groups in NCT04032834
Study group	Role	What they receive
Part 1, Arm A of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Part 1, Arm B of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Part 1, Arm C of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Part 1, Arm D of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Part 1, Arm E of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Part 1, Arm F of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece
Part 2, Arm A of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 2, Arm B of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 2, Arm C of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 2, Arm D of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 2, Arm E of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 2, Arm F of single-dose, 6-treatment, 6-period crossover	Other	Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 3, Arm A of single-dose, 4-treatment, 4-period crossover	Other	Subjects received the following treatments in Periods 1 to 4 in a crossover fashion: 15 breaths (120 µg) VR647 via mouthpiece, 15 breaths (120 µg) VR647 via facemask, 0.5 mg budesonide via mouthpiece, 0.5 mg budesonide via facemask. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 3, Arm B of single-dose, 4-treatment, 4-period crossover	Other	Subjects received the following treatments in Periods 1 to 4 in a crossover fashion: 15 breaths (120 µg) VR647 via facemask, 0.5 mg budesonide via mouthpiece, 0.5 mg budesonide via facemask, 15 breaths (120 µg) VR647 via mouthpiece. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 3, Arm C of single-dose, 4-treatment, 4-period crossover	Other	Subjects received the following treatments in Periods 1 to 4 in a crossover fashion: 0.5 mg budesonide via mouthpiece, 0.5 mg budesonide via facemask, 15 breaths (120 µg) VR647 via mouthpiece, 15 breaths (120 µg) VR647 via facemask. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Part 3, Arm D of single-dose, 4-treatment, 4-period crossover	Other	Subjects received the following treatments in Periods 1 to 4 in a crossover fashion: 0.5 mg budesonide via facemask, 15 breaths (120 µg) VR647 via mouthpiece, 15 breaths (120 µg) VR647 via facemask, 0.5 mg budesonide via mouthpiece. Receives: Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask

What is being measured

The primary outcome is the main question the study is designed to answer.

AUClast (area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration).
AUClast (area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
Measured: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
AUCinf (area under the plasma concentration-time curve, from time 0 extrapolated to infinity).
AUCinf (area under the plasma concentration-time curve, from time 0 extrapolated to infinity) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
Measured: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
Cmax (maximum observed concentration).
Cmax (maximum observed concentration) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
Measured: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
Tmax (time to reach Cmax).
Tmax (time to reach Cmax) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
Measured: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
T1/2 (apparent first-order terminal elimination half-life).
T1/2 (apparent first-order terminal elimination half-life) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
Measured: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3

Secondary outcomes (3)

Number of adverse events (AEs) and serious adverse events (SAEs).
Adverse events occurring from the time of the subject giving informed consent until Follow-up/early discontinuation.
Measured: Part 1 and Part 2: approximately 64 days; Part 3: approximately 42 days
Number of adverse device effects (ADEs) and serious adverse device effects (SADEs).
Adverse device effects occurring from the time of the subject giving informed consent until the Follow up/early discontinuation.
Measured: Part 1 and Part 2: approximately 64 days; Part 3: approximately 42 days
Subjects with use of concomitant medications.
Concomitant medication use will be collected and coded using the World Health Organization Drug Dictionary.
Measured: Part 1 and Part 2: approximately 64 days; Part 3: approximately 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201722 May 2017

First posted25 Jul 2019
Study start20 Feb 2017
Primary completion22 May 2017
Study completion22 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This is a three part, randomized, open-label, crossover, Phase 1 trial in adults. Parts 1 and 2 are comparative single dose, 6-treatment, 6-period crossover trials with a mouthpiece or facemask, respectively, in healthy adults. Subjects will receive 4 dose levels of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) (5, 10, 15 and 25 breaths, with a targeted doses of 30, 60 120 and 240 µg) and 2 dose levels of budesonide delivered by conventional jet nebulizer (PARI VIOS) (0.5 and 1 mg). Part 3 is a comparative single dose, 4-treatment, 4-period crossover trial in subjects with mild asthma. Subjects will receive doses of VR647 Inhalation Suspension (15 breaths, with a targeted dose of 120 µg) delivered by the VR647 Inhalation System (AKITA JET) with facemask or mouthpiece and budesonide (0.5 mg) delivered by conventional jet nebulizer (PARI VIOS) with facemask or mouthpiece.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04032834
Sponsor's protocol ID: VR647/1/001
Status last verified: Jul 2019
First submitted: 4 Jul 2019
Last updated: 25 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Crossover Trial to Compare the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Delivered by the VR647 Inhalation System (VR647) With Single Doses of Budesonide Delivered by a Conventional Jet Nebulizer in Healthy Adult Volunteers and Adult Asthma Subjects
ClinicalTrials.gov ID: NCT04032834
Acronym / sponsor ID: VR647/1/001
Conditions: Asthma
Keywords: Asthma, Budesonide, Nebulizer, Pharmacokinetics, AKITA JET
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Vectura LimitedIndustry (pharma, biotech, devices)
Study start: 20 Feb 2017 (actual)
Primary completion: 22 May 2017 (actual)
Study completion: 22 May 2017 (actual)
First posted: 25 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Part 1:

Part 2:

Part 3:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 16
Model description: This is a three part, randomized, open-label, crossover, Phase 1 trial in adults. Parts 1 and 2 are comparative single dose, 6-treatment, 6-period crossover trials with a mouthpiece or facemask, respectively, in healthy adults. Subjects will receive 4 dose levels of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) (5, 10, 15 and 25 breaths, with a targeted doses of 30, 60 120 and 240 µg) and 2 dose levels of budesonide delivered by conventional jet nebulizer (PARI VIOS) (0.5 and 1 mg). Part 3 is a comparative single dose, 4-treatment, 4-period crossover trial in subjects with mild asthma. Subjects will receive doses of VR647 Inhalation Suspension (15 breaths, with a targeted dose of 120 µg) delivered by the VR647 Inhalation System (AKITA JET) with facemask or mouthpiece and budesonide (0.5 mg) delivered by conventional jet nebulizer (PARI VIOS) with facemask or mouthpiece.

Arm	Type	Receives
Part 1, Arm A of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide.
Part 1, Arm B of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide.
Part 1, Arm C of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647.
Part 1, Arm D of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647.
Part 1, Arm E of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647.
Part 1, Arm F of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647.
Part 2, Arm A of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide.
Part 2, Arm B of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide.
Part 2, Arm C of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647.
Part 2, Arm D of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647.
Part 2, Arm E of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647.
Part 2, Arm F of single-dose, 6-treatment, 6-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 6 in a crossover fashion: 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide, 5 breaths (30 µg) VR647.
Part 3, Arm A of single-dose, 4-treatment, 4-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 4 in a crossover fashion: 15 breaths (120 µg) VR647 via mouthpiece, 15 breaths (120 µg) VR647 via facemask, 0.5 mg budesonide via mouthpiece, 0.5 mg budesonide via facemask.
Part 3, Arm B of single-dose, 4-treatment, 4-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 4 in a crossover fashion: 15 breaths (120 µg) VR647 via facemask, 0.5 mg budesonide via mouthpiece, 0.5 mg budesonide via facemask, 15 breaths (120 µg) VR647 via mouthpiece.
Part 3, Arm C of single-dose, 4-treatment, 4-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 4 in a crossover fashion: 0.5 mg budesonide via mouthpiece, 0.5 mg budesonide via facemask, 15 breaths (120 µg) VR647 via mouthpiece, 15 breaths (120 µg) VR647 via facemask.
Part 3, Arm D of single-dose, 4-treatment, 4-period crossover	Other	Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece, Combination Product: VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece, Combination Product: 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskSubjects received the following treatments in Periods 1 to 4 in a crossover fashion: 0.5 mg budesonide via facemask, 15 breaths (120 µg) VR647 via mouthpiece, 15 breaths (120 µg) VR647 via facemask, 0.5 mg budesonide via mouthpiece.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Male or female subject
Female subjects must have a negative pregnancy test at the Screening and Day -1 Visits (prior to dosing), must be using a reliable form of contraception throughout the trial, or must be of non-childbearing potential as follows:
Aged 18 to 55 years
Hemoglobin level of ≥11.5 g/dL for females and ≥13.0 g/dL for males
Weigh at least 50 kg, and body mass index (Quetelet index) in the range 18.0-32.0 kg/m2, inclusive

Key exclusion criteria (24 listed)

Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the subject (excluding mild asthma in Part 3)
Subjects who have impaired cardiovascular, endocrine, autoimmune, metabolic, neurological, renal, respiratory (excluding mild asthma in Part 3), gastrointestinal, hepatic, hematological or any other system abnormalities
Respiratory tract infection within 4 weeks before the Screening Visit
History of surgery or medical intervention within 6 weeks before the Screening Visit, or planned surgery or medical intervention, that could interfere with the objectives of the trial or the safety of the subject
Regular treatment (more than 1 month duration) with oral or parenteral corticosteroids in the last year prior to the Screening Visit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpieceThe VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a mouthpiece and dose-specific VR647 Smart Cards designed specifically for this trial.	Combination product	Part 1, Arm A of single-dose, 6-treatment, 6-period crossover, Part 1, Arm B of single-dose, 6-treatment, 6-period crossover, Part 1, Arm C of single-dose, 6-treatment, 6-period crossover, Part 1, Arm D of single-dose, 6-treatment, 6-period crossover, Part 1, Arm E of single-dose, 6-treatment, 6-period crossover, Part 1, Arm F of single-dose, 6-treatment, 6-period crossover, Part 3, Arm A of single-dose, 4-treatment, 4-period crossover, Part 3, Arm B of single-dose, 4-treatment, 4-period crossover, Part 3, Arm C of single-dose, 4-treatment, 4-period crossover, Part 3, Arm D of single-dose, 4-treatment, 4-period crossover
VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemaskThe VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a facemask and dose-specific VR647 Smart Cards designed specifically for this trial.	Combination product	Part 2, Arm A of single-dose, 6-treatment, 6-period crossover, Part 2, Arm B of single-dose, 6-treatment, 6-period crossover, Part 2, Arm C of single-dose, 6-treatment, 6-period crossover, Part 2, Arm D of single-dose, 6-treatment, 6-period crossover, Part 2, Arm E of single-dose, 6-treatment, 6-period crossover, Part 2, Arm F of single-dose, 6-treatment, 6-period crossover, Part 3, Arm A of single-dose, 4-treatment, 4-period crossover, Part 3, Arm B of single-dose, 4-treatment, 4-period crossover, Part 3, Arm C of single-dose, 4-treatment, 4-period crossover, Part 3, Arm D of single-dose, 4-treatment, 4-period crossover
1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceCommercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.	Combination product	Part 1, Arm A of single-dose, 6-treatment, 6-period crossover, Part 1, Arm B of single-dose, 6-treatment, 6-period crossover, Part 1, Arm C of single-dose, 6-treatment, 6-period crossover, Part 1, Arm D of single-dose, 6-treatment, 6-period crossover, Part 1, Arm E of single-dose, 6-treatment, 6-period crossover, Part 1, Arm F of single-dose, 6-treatment, 6-period crossover
1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskCommercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.	Combination product	Part 2, Arm A of single-dose, 6-treatment, 6-period crossover, Part 2, Arm B of single-dose, 6-treatment, 6-period crossover, Part 2, Arm C of single-dose, 6-treatment, 6-period crossover, Part 2, Arm D of single-dose, 6-treatment, 6-period crossover, Part 2, Arm E of single-dose, 6-treatment, 6-period crossover, Part 2, Arm F of single-dose, 6-treatment, 6-period crossover
0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpieceCommercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.	Combination product	Part 1, Arm A of single-dose, 6-treatment, 6-period crossover, Part 1, Arm B of single-dose, 6-treatment, 6-period crossover, Part 1, Arm C of single-dose, 6-treatment, 6-period crossover, Part 1, Arm D of single-dose, 6-treatment, 6-period crossover, Part 1, Arm E of single-dose, 6-treatment, 6-period crossover, Part 1, Arm F of single-dose, 6-treatment, 6-period crossover, Part 3, Arm A of single-dose, 4-treatment, 4-period crossover, Part 3, Arm B of single-dose, 4-treatment, 4-period crossover, Part 3, Arm C of single-dose, 4-treatment, 4-period crossover, Part 3, Arm D of single-dose, 4-treatment, 4-period crossover
0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemaskCommercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.	Combination product	Part 2, Arm A of single-dose, 6-treatment, 6-period crossover, Part 2, Arm B of single-dose, 6-treatment, 6-period crossover, Part 2, Arm C of single-dose, 6-treatment, 6-period crossover, Part 2, Arm D of single-dose, 6-treatment, 6-period crossover, Part 2, Arm E of single-dose, 6-treatment, 6-period crossover, Part 2, Arm F of single-dose, 6-treatment, 6-period crossover, Part 3, Arm A of single-dose, 4-treatment, 4-period crossover, Part 3, Arm B of single-dose, 4-treatment, 4-period crossover, Part 3, Arm C of single-dose, 4-treatment, 4-period crossover, Part 3, Arm D of single-dose, 4-treatment, 4-period crossover

Primary outcome

AUClast (area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration).
Time frame: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
AUClast (area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
AUCinf (area under the plasma concentration-time curve, from time 0 extrapolated to infinity).
Time frame: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
AUCinf (area under the plasma concentration-time curve, from time 0 extrapolated to infinity) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
Cmax (maximum observed concentration).
Time frame: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
Cmax (maximum observed concentration) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
Tmax (time to reach Cmax).
Time frame: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
Tmax (time to reach Cmax) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.
T1/2 (apparent first-order terminal elimination half-life).
Time frame: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3
T1/2 (apparent first-order terminal elimination half-life) compared for single doses of VR647 delivered by VR647 Inhalation System (AKITA JET) with single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS) via a mouthpiece in healthy volunteers, via a facemask in healthy volunteers, and via either a mouthpiece or a facemask in adult subjects with mild asthma.

3 secondary outcomes

Number of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Part 1 and Part 2: approximately 64 days; Part 3: approximately 42 days
Number of adverse device effects (ADEs) and serious adverse device effects (SADEs).
Time frame: Part 1 and Part 2: approximately 64 days; Part 3: approximately 42 days
Subjects with use of concomitant medications.
Time frame: Part 1 and Part 2: approximately 64 days; Part 3: approximately 42 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gary Burgess, MD study director

Vectura Ltd

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUClast (area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration). (time frame: pre-dose and at 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after start of nebulization for Parts 1, 2 and 3). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04032834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.