Pulmonary Disease, Chronic ObstructivePhase 1NCT03740373

A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate

A Phase 1 study testing BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold and BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold in people with Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in United Kingdom.

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

This study is a 2 treatment period, single dose crossover, gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler. Read more about this study

Who is it for?: Ages 28 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold and BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited Kingdom
Study dates: 4 Sep 2018to 11 Oct 2018
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 28 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males between 28 and 50 years of age inclusive;
Male subject willing to wear a condom and whose partner of child bearing potential uses a highly effective method of contraception (e.g. partner use of intrauterine device (IUD)) or an effective method of contraception, i.e., established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from first dose until 3 months after last dose of IMP;
Subjects who have a body weight ≥50 kg at the Screening Visit and Subjects with a body mass index (BMI) of 18-30; BMI = body weight (kg) / [height (m)]2.
Subject with no clinically significant history of previous allergy / sensitivity to Budesonide, Glycopyrronium and Formoterol Fumarate or any of the excipients contained within the IMP;
Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 28 days before the first dose of IMP;
Subject with a negative urinary drugs of abuse screen, determined within 28 days before the first dose of IMP (N.B. a positive alcohol result may be repeated at Investigator's discretion);

Show all 12Show fewer

Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results;
Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IMP;
Subject with no clinically significant abnormalities in vital signs (e.g., blood pressure/pulse, respiration rate, oral temperature) determined within 28 days before first dose of IMP (Supine BP <140/90 mmHg or resting HR<100 beats per minute);
Subject must be available to complete the study (including all follow up contact);
Subject must satisfy a medical examiner about their fitness to participate in the study;
Subject must provide written informed consent to participate in the study.

Who cannot join

Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, haematological, psychiatric, or other medical illness that would interfere with participation in this study;
Subjects with a history of ECG abnormalities including PR>220 msec; QRS complex >120 msec; QT Corrected Using Fridericia's Formula (QTcF) >450 ms; or any significant morphological changes other than non-specific T wave changes;
A history of additional risk factors for Torsades de Pointes (e.g., heart failure, family history of Long QT Syndrome);
Subjects who have cancer that has not been in complete remission for at least 5 years;
Subjects with a FEV1 < 80% of predicted value and/or a FEV1/FVC ratio < 0.7 at screening. Subjects must be able to perform reliable, reproducible pulmonary function test manoeuvres per American Thoracic Society / European Respiratory Society (ATS/ERS) guidelines;
Subjects with symptomatic prostatic hypertrophy / prostrate resection within 6 months of screening / bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator;

Show all 25Show fewer

Subjects with a family history of glaucoma or a diagnosis of glaucoma;
History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), fourth edition, text revision within 1 year of Screening;
History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting;
A positive alcohol or urine drug screen including cotinine for drugs of abuse at the Screening Visit or at the beginning of each treatment period;
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP, unless in the opinion of the Investigator and Sponsor's Responsible Physician the medication will not interfere with the study procedures or compromise subject safety. Paracetamol will be permitted at doses of ≤4 grams/day;
Subjects with a history of an allergic reaction or hypersensitivity to the study drugs, or who develop allergic reaction or hypersensitivity to any component of the formulation(s) used in this study including 99mTc;
Subjects with a chronic medical condition that requires ongoing treatment with medication;
Subjects with a history of major surgery within 4 weeks or minor surgery within 2 weeks of drug administration;
Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration;
Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study drug non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study related procedures);
Subjects with abnormal-glomerular filtration rate (GFR; estimated GFR <90 mL/min/1.73m2) using the Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI);
Participation in a study in which radioisotopes were administered within 12 months preceding the first dose of Period 1 of this study, or has been exposed to radiation excess within the last 12 months (e.g., x-rays, handling of radiolabel materials). Radiation excess will be determined on a case-by-case basis following review by the Principal Investigator or designee;
Subjects with abnormal findings in a previous chest X ray or CT scan;
Subjects who in the opinion of the Investigator are unable to demonstrate acceptable use of the MDI device (including sufficient inspiratory flow rate) and exhalation filter after training;
Subjects with any abnormal findings on the 81mKr ventilation scan performed during Treatment Period 1;
Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction;
A clinically significant history of drug or alcohol abuse;
Inability to communicate well with Investigators (i.e., language problem, poor mental development or impaired cerebral function);
Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
Pentrebach, CF48 4DR

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomised, Two-Period, Single-Dose, Single-Centre, Crossover Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI, Following 3 s and 10 s Breath-Hold, in Healthy Male Subjects

This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold.

The study will involve the following visits: 1 screening visits, 2 treatment visits, each separated by around 7 days (each with 1 overnight stay; from the evening before dosing until a minimum of 4 hours post-dose on the morning of Day 1) and a post-study follow up phone call.

The study population will be 10 healthy males, aged between 28 and 50 years of age.

Read the detailed description

This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold.

This inhaler is intended to be used in the treatment of Chronic Obstructive Pulmonary Disease (COPD), which is a group of diseases which cause lung problems and difficulty breathing.

PT010 contains a combination of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

Budesonide is a corticosteroid that works by preventing inflammation and thus can aid in respiratory diseases such as chronic obstructive pulmonary disease. Glycopyrronium \& Formoterol Fumarate are bronchodilators which act by relaxing the smooth muscle cells in the trachea and bronchi, allowing greater airflow into the lungs.

To enable us to determine how much of the drug gets into the lungs following different lengths of breath hold, a technique called gamma scintigraphy will be used. Gamma scintigraphy is a technique used to track the movement of a radiolabelled tracer inside the body.

By assessing the amount of PT010 in the lungs following different lengths of breath hold, it is intended that this information will provide guidance as to the most effective way of taking the inhaler.

The study population will be 10 healthy males, aged between 28 and 50 years of age.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold, BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath holdDrug
Also called PT010 with 10 s breath hold
Participants will receive a single dose of BGF MDI; the dose will be administered with a 10 s breath-hold.
BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath holdDrug
Also called PT010 with 3 s breath hold
Participants will receive a single dose of BGF MDI; the dose will be administered with a 3 s breath-hold.

Study groups in NCT03740373
Study group	Role	What they receive
Treatment Sequence 1	Experimental	Subjects will receive BGF MDI with 10 s breath hold during Treatment Period 1 and BGF MDI with 3 s breath hold during Treatment Period 2 Receives: Drug: BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold; Drug: BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold
Treatment Sequence 2	Experimental	Subjects will receive BGF MDI with 3 s breath hold during Treatment Period 1 and BGF MDI with 10 s breath hold during Treatment Period 2 Receives: Drug: BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold; Drug: BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold

What is being measured

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

Percentage lung deposition following 10 s breath hold
The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following 10 s breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)

Secondary outcomes (7)

Percentage lung deposition following 3 s breath hold
The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following 3 s breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)
Regional airway deposition following 10 s breath hold
The regional airway deposition ratios including outer to inner (O/I) and central to peripheral (C/P) regions of the radiolabelled BGF MDI following a 10 s breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)
Oropharyngeal and stomach deposition following 10 s breath hold
The fraction of the dose of radiolabelled BGF MDI deposited in the oropharyngeal and stomach regions (expressed as % emitted dose) following a 10 sec breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)
Actuator and exhalation filter deposition following 10 s breath hold
The fraction of the dose of radiolabelled BGF MDI deposited on the actuator (expressed as % ex-valve dose) and exhalation filter (expressed as % emitted dose) following a 10 s breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)
Regional airway deposition following 3 s breath hold
The regional airway deposition ratios including outer to inner (O/I) and central to peripheral (C/P) regions of the radiolabelled BGF MDI following a 3 s breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)
Oropharyngeal and stomach deposition following 3 s breath hold
The fraction of the dose of radiolabelled BGF MDI deposited in the oropharyngeal and stomach regions (expressed as % emitted dose) following a 3 s breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)
Actuator and exhalation filter deposition following 3 s breath hold
The fraction of the dose of radiolabelled BGF MDI deposited on the actuator (expressed as % ex-valve dose) and exhalation filter (expressed as % emitted dose) following a 3 s breath hold.
Measured: Day 1 (of either Treatment Period 1 or 2)

Timeline

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

4 Sep 201811 Oct 2018

First posted14 Nov 2018
Study start4 Sep 2018
Primary completion11 Oct 2018
Study completion11 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03740373
Sponsor's protocol ID: D5980C00007
Status last verified: Nov 2018
First submitted: 3 Aug 2018
Last updated: 14 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomised, Two-Period, Single-Dose, Single-Centre, Crossover Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI, Following 3 s and 10 s Breath-Hold, in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03740373
Acronym / sponsor ID: D5980C00007
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 4 Sep 2018 (actual)
Primary completion: 11 Oct 2018 (actual)
Study completion: 11 Oct 2018 (actual)
First posted: 14 Nov 2018 (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.

This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold.

The study population will be 10 healthy males, aged between 28 and 50 years of age.

Detailed description

This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold.

This inhaler is intended to be used in the treatment of Chronic Obstructive Pulmonary Disease (COPD), which is a group of diseases which cause lung problems and difficulty breathing.

PT010 contains a combination of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

The study population will be 10 healthy males, aged between 28 and 50 years of age.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment Sequence 1	Experimental	Drug: BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold, Drug: BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath holdSubjects will receive BGF MDI with 10 s breath hold during Treatment Period 1 and BGF MDI with 3 s breath hold during Treatment Period 2
Treatment Sequence 2	Experimental	Drug: BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold, Drug: BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath holdSubjects will receive BGF MDI with 3 s breath hold during Treatment Period 1 and BGF MDI with 10 s breath hold during Treatment Period 2

Who may qualify

Ages: 28 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy males between 28 and 50 years of age inclusive;
Male subject willing to wear a condom and whose partner of child bearing potential uses a highly effective method of contraception (e.g. partner use of intrauterine device (IUD)) or an effective method of contraception, i.e., established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from first dose until 3 months after last dose of IMP;
Subjects who have a body weight ≥50 kg at the Screening Visit and Subjects with a body mass index (BMI) of 18-30; BMI = body weight (kg) / [height (m)]2.
Subject with no clinically significant history of previous allergy / sensitivity to Budesonide, Glycopyrronium and Formoterol Fumarate or any of the excipients contained within the IMP;
Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 28 days before the first dose of IMP;

Key exclusion criteria (25 listed)

Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, haematological, psychiatric, or other medical illness that would interfere with participation in this study;
Subjects with a history of ECG abnormalities including PR>220 msec; QRS complex >120 msec; QT Corrected Using Fridericia's Formula (QTcF) >450 ms; or any significant morphological changes other than non-specific T wave changes;
A history of additional risk factors for Torsades de Pointes (e.g., heart failure, family history of Long QT Syndrome);
Subjects who have cancer that has not been in complete remission for at least 5 years;
Subjects with a FEV1 < 80% of predicted value and/or a FEV1/FVC ratio < 0.7 at screening. Subjects must be able to perform reliable, reproducible pulmonary function test manoeuvres per American Thoracic Society / European Respiratory Society (ATS/ERS) guidelines;

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
BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath holdAlso: PT010 with 10 s breath holdParticipants will receive a single dose of BGF MDI; the dose will be administered with a 10 s breath-hold.	Drug	Treatment Sequence 1, Treatment Sequence 2
BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath holdAlso: PT010 with 3 s breath holdParticipants will receive a single dose of BGF MDI; the dose will be administered with a 3 s breath-hold.	Drug	Treatment Sequence 1, Treatment Sequence 2

Primary outcome

Percentage lung deposition following 10 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)
The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following 10 s breath hold.

7 secondary outcomes

Percentage lung deposition following 3 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)
Regional airway deposition following 10 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)
Oropharyngeal and stomach deposition following 10 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)
Actuator and exhalation filter deposition following 10 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)
Regional airway deposition following 3 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)
Oropharyngeal and stomach deposition following 3 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)
Actuator and exhalation filter deposition following 3 s breath hold
Time frame: Day 1 (of either Treatment Period 1 or 2)

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 14 Nov 2018.

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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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.

Samuel Israel principal investigator

Simbec Research

1 site 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 12 inclusion and 25 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Percentage lung deposition following 10 s breath hold (time frame: Day 1 (of either Treatment Period 1 or 2)). 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 NCT03740373.

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 14 Nov 2018.