AsthmaPhase 1NCT02631941

Clinical Study to Evaluate Z7200 Pharmacokinetics Profile

A Phase 1 study testing Z7200 without oral activated charcoal, Symbicort Turbohaler without oral activated charcoal and Z7200 with oral activated charcoal in people with Asthma, run by Zambon SpA 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

Brief Summary: The primary objective was: to assess the bioequivalence of a single dose (two inhalations) of the test product compared to the reference product, with and without charcoal blockade. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: Z7200 without oral activated charcoal, Symbicort Turbohaler without oral activated charcoal and Z7200 with oral activated charcoal
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteUnited Kingdom
Study dates: Jan 2016to Jul 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Main Inclusion Criteria:

Male or female 18 to 45 years of age.
If female, is currently not pregnant/breast feeding/ or attempting to become pregnant has a negative serum pregnancy test, or is of non-childbearing potential or is of child-bearing potential, willing to commit to using a consistent and acceptable method of birth control or is of child-bearing potential and not sexually active
Body mass index (BMI) of 18.0 to 32.0 kg/m² inclusive and a body weight ≥50 kg.
10 years or more past history of cigarette, <=5 pack year

Main Exclusion Criteria:

Forced Expiratory Volume in 1 sec (FEV1) value less than 80% of the predicted value and FEV1/FVC (Forced Vital Capacity) ratio <0.7.
History or current evidence of a clinically significant disease or disorder capable of altering the absorption, metabolism, distribution or elimination of drugs.
History or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, haematological, neuropsychological, endocrine, gastrointestinal or pulmonary.
Presence of glaucoma, cataracts, ocular herpes simplex, malignancy, regardless of the clinical significance or current stability of the disease.
positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C.
Bacterial or viral infection of the upper respiratory tract (including the common cold and flu), sinus, or middle ear within 2 weeks of dosing.
Lower respiratory tract infection/pneumonia within the past 3 months.
Presence of any disease or condition or regular concomitant treatment (including vitamins and herbal products) known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Screening haemoglobin value of less than 1g/dL above the Lower Limit of Normality
History of recurrent vasovagal collapses.
History of anaphylactic/anaphylactoid reactions.
History of seizures including febrile seizures excluding childhood febrile convulsions.
Unable to demonstrate proper inhalation techniques involved in using the delivery devices at screening.
Exposure to any investigational drug within 90 days of the Screening Visit.
Known or suspected hypersensitivity or idiosyncratic reaction to any steroid, any β2 agonist; allergy to milk protein.
Use of an inhaled corticosteroid within 30 days or systemic corticosteroid within 60 days of the Screening Visit.
Use of medications or herbal medicines that are strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 30 days prior to Screening Visit
Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
Use of caffeine containing beverages more than 5 cups/day.
Recent or current (suspected) drug abuse or positive result in the drugs abuse test.
Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 14 units per week for females)
Predictable poor compliance, intolerance to charcoal solution, or inability to communicate well with the study centre personnel or inability to participate in all treatment periods.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Clinical Ltd
Ruddington, NG11 6JS

Other trials in United Kingdom

About this study

Official title: An Open-Label, Randomized, Five-Period Cross-over, Single-dose Study to Compare Pharmacokinetics Profiles of Z7200 Medium Strength and Symbicort Turbohaler, With and Without Charcoal Blockade in Healthy Volunteers.

Brief Summary:

The primary objective was:

to assess the bioequivalence of a single dose (two inhalations) of the test product compared to the reference product, with and without charcoal blockade.

The secondary objectives were:

to assess the pharmacokinetic profile of budesonide and formoterol in plasma after a single dose (two inhalations) of the test product and the reference product, with and without charcoal blockade.
to assess the safety and tolerability of the test product and the reference product, with and without charcoal blockade.

Read the detailed description

This was a single center, open label, randomized, five-period crossover, single-dose study in healthy volunteers aged 18 to 45 years. A total of 90 volunteers were planned to be enrolled, with 9 subjects in each of the 10 treatment sequences.

The study consisted of 5 treatment periods, each lasting approximately 48h, separated by a washout period of a minimum of 5 days. RS01 and/or Symbicort Turbohaler device use training was provided on Day -1 and Day 1 of each treatment period. Subjects were screened for eligibility to participate in the study -28 to -2 days prior to the first treatment period, and were randomized to one of 10 treatment sequences containing the following 5 treatment arms on Day 1 of the first treatment period:

Treatment A: Z7200 without oral activated charcoal* Treatment B1: Symbicort 1 without oral activated charcoal* Treatment B2: Symbicort 2 without oral activated charcoal* Treatment C: Z7200 with oral activated charcoal Treatment D: Symbicort with oral activated charcoal

Subjects were admitted to the clinical unit at 8.00 on the morning of Day -1, and were dosed on the morning of Day 1 following an overnight fast (minimum of 8h). On Day 2, following collection of the 24-h PK blood sample, subjects were discharged.

Subjects who received treatments A, B1 and B2 rinsed their mouth vigorously with 50 mL water for 3 to 5 sec immediately after the second inhalation.

** A charcoal blockade was used to prevent absorption from oropharyngeal and GI tract, in order to assess the pulmonary deposition of budesonide and formoterol, with periods performed without a charcoal blockade allowing the assessment of the total systemic exposure to the drug.

Conditions: Asthma
Being tested: Z7200 without oral activated charcoal, Symbicort Turbohaler without oral activated charcoal, Z7200 with oral activated charcoal, Symbicort Turbohaler with oral activated charcoal
Medical subject headings: Asthma

What participants receive

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

Z7200 without oral activated charcoalDrug
Also called budesonide/formoterol
160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).
Symbicort Turbohaler without oral activated charcoalDrug
Also called budesonide/formoterol
320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2 denote Symbicort without oral activated charcoal administered in two different periods).
Z7200 with oral activated charcoalDrug
Also called budesonide/formoterol with coadministration of charcoal
160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).
Symbicort Turbohaler with oral activated charcoalDrug
Also called budesonide/formoterol with coadministration of charcoal
320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation from a Symbicort Turbohaler, with charcoal blockade (Treatment D).

Study groups in NCT02631941
Study group	Role	What they receive
A-B1-B2-C-D	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 days followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
B1-C-A-D-B2	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
C-D-B1-B2-A	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
D-B2-C-A-B1	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
B2-A-D-B1-C	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
D-C-B2-B1-A	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
B2-D-A-C-B1	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
A-B2-B1-D-C	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
B1-A-C-B2-D	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal
C-B1-D-A-B2	Experimental	Subjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2. Receives: Drug: Z7200 without oral activated charcoal; Drug: Symbicort Turbohaler without oral activated charcoal; Drug: Z7200 with oral activated charcoal; Drug: Symbicort Turbohaler with oral activated charcoal

What is being measured

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

AUC0-last of Budesonide With and Without Charcoal Blockade
Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
AUC0-last of Formoterol With and Without Charcoal Blockade
Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Cmax of Budesonide With and Without Charcoal Blockade
Maximum plasma level of budesonide with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Cmax of Formoterol With and Without Charcoal Blockade
Maximum plasma level of formoterol with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)

Secondary outcomes (11)

AUC0-30 of Budesonide With and Without Charcoal Blockade.
Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-30 min (0, 2, 5, 10, 15, 20, and 30 min)
AUC0-30 of Formoterol With and Without Charcoal Blockade.
Area under the plasma concentration-time curve from time zero to 30 minutes calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-30 min (0, 2, 5, 10, 15, 20, and 30 min)
AUC0-∞ of Budesonide With and Without Charcoal Blockade
Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
AUC0-∞ of Formoterol With and Without Charcoal Blockade
Area under the plasma concentration-time curve from time zero to infinity calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Tmax for Budesonide With and Without Charcoal Blockade
Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Tmax for Formoterol With and Without Charcoal Blockade
Time at which the maximum plasma level (Cmax) occurred with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
t1/2 for Budesonide With and Without Charcoal Blockade
Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
t1/2 for Formoterol With and Without Charcoal Blockade
Apparent elimination half-life calculated as 0.693/lambda zeta, with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 refers to the volume of air that an individual can exhale during a forced breath in 1 second. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: At 75 min (1.25 hours) post-dose
Change From Baseline in the Ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC)
FVC = Forced vital capacity. It is the full amount of air that can be exhaled with effort in a complete breath.
FEV1/FVC = Tiffenau-Pinelli Index. This parameter represents the measurement of the amount of air an individual can forcefully exhale from his/her lungs. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: At 75 min (1.25 hours) post-dose
Change From Baseline in Peak Expiratory Flow Rate (PEFR)
PEFR is the highest rate at which gases can be expelled from the lungs via an open mouth. Its measurement is a simple procedure in which an individual takes a full inspiration and blows out as forcibly as possible into an instrument called a peak flow meter, which measures the maximal gas flow in an exhalation in liters per minute. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Measured: At 75 min (1.25 hours) post-dose

Timeline

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

Jan 2016Jul 2016

First posted16 Dec 2015 (estimated)
Study startJan 2016
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02631941
Sponsor's protocol ID: Z7200J04
Other IDs: 2015-003233-95, 2015
Status last verified: Feb 2022
First submitted: 14 Dec 2015
Last updated: 23 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Five-Period Cross-over, Single-dose Study to Compare Pharmacokinetics Profiles of Z7200 Medium Strength and Symbicort Turbohaler, With and Without Charcoal Blockade in Healthy Volunteers.
ClinicalTrials.gov ID: NCT02631941
Acronym / sponsor ID: Z7200J04
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Zambon SpAIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 16 Dec 2015 (estimated)
Results: Posted 26 Jan 2022

Clinical summary

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

Brief Summary:

The primary objective was:

to assess the bioequivalence of a single dose (two inhalations) of the test product compared to the reference product, with and without charcoal blockade.

The secondary objectives were:

to assess the pharmacokinetic profile of budesonide and formoterol in plasma after a single dose (two inhalations) of the test product and the reference product, with and without charcoal blockade.
to assess the safety and tolerability of the test product and the reference product, with and without charcoal blockade.

Detailed description

Subjects who received treatments A, B1 and B2 rinsed their mouth vigorously with 50 mL water for 3 to 5 sec immediately after the second inhalation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
A-B1-B2-C-D	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following 5 treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 days followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
B1-C-A-D-B2	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
C-D-B1-B2-A	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
D-B2-C-A-B1	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
B2-A-D-B1-C	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
D-C-B2-B1-A	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
B2-D-A-C-B1	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
A-B2-B1-D-C	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
B1-A-C-B2-D	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.
C-B1-D-A-B2	Experimental	Drug: Z7200 without oral activated charcoal, Drug: Symbicort Turbohaler without oral activated charcoal, Drug: Z7200 with oral activated charcoal, Drug: Symbicort Turbohaler with oral activated charcoalSubjects were dosed on Day 1 of each treatment period with one of the following five treatments according to the randomization schedule using a Williams Latin Square design: 1. Treatment A: Z7200 without oral activated charcoal 2. Treatment B1: Symbicort 1 without oral activated charcoal 3. Treatment B2: Symbicort 2 without oral activated charcoal 4. Treatment C: Z7200 with oral activated charcoal 5. Treatment D: Symbicort with oral activated charcoal A washout period of a minimum of 5 day followed treatment periods 1 to 4. Treatment B1 and B2 denote Symbicort without oral activated charcoal administered in two different period, designated as Symbicort 1 and Symbicort 2.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

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
Z7200 without oral activated charcoalAlso: budesonide/formoterol160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).	Drug	A-B1-B2-C-D, A-B2-B1-D-C, B1-A-C-B2-D, B1-C-A-D-B2, B2-A-D-B1-C, B2-D-A-C-B1, C-B1-D-A-B2, C-D-B1-B2-A, D-B2-C-A-B1, D-C-B2-B1-A
Symbicort Turbohaler without oral activated charcoalAlso: budesonide/formoterol320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2 denote Symbicort without oral activated charcoal administered in two different periods).	Drug	A-B1-B2-C-D, A-B2-B1-D-C, B1-A-C-B2-D, B1-C-A-D-B2, B2-A-D-B1-C, B2-D-A-C-B1, C-B1-D-A-B2, C-D-B1-B2-A, D-B2-C-A-B1, D-C-B2-B1-A
Z7200 with oral activated charcoalAlso: budesonide/formoterol with coadministration of charcoal160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).	Drug	A-B1-B2-C-D, A-B2-B1-D-C, B1-A-C-B2-D, B1-C-A-D-B2, B2-A-D-B1-C, B2-D-A-C-B1, C-B1-D-A-B2, C-D-B1-B2-A, D-B2-C-A-B1, D-C-B2-B1-A
Symbicort Turbohaler with oral activated charcoalAlso: budesonide/formoterol with coadministration of charcoal320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation from a Symbicort Turbohaler, with charcoal blockade (Treatment D).	Drug	A-B1-B2-C-D, A-B2-B1-D-C, B1-A-C-B2-D, B1-C-A-D-B2, B2-A-D-B1-C, B2-D-A-C-B1, C-B1-D-A-B2, C-D-B1-B2-A, D-B2-C-A-B1, D-C-B2-B1-A

Primary outcome

AUC0-last of Budesonide With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
AUC0-last of Formoterol With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Area under the plasma concentration-time curve from time zero to the last detectable level calculations were performed using the linear trapezoidal rule. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Cmax of Budesonide With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Maximum plasma level of budesonide with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.
Cmax of Formoterol With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Maximum plasma level of formoterol with and without charcoal blockade. Participants for the Treatment B are counted for both Symbicort 1 and Symbicort 2, together.

11 secondary outcomes

AUC0-30 of Budesonide With and Without Charcoal Blockade.
Time frame: 0-30 min (0, 2, 5, 10, 15, 20, and 30 min)
AUC0-30 of Formoterol With and Without Charcoal Blockade.
Time frame: 0-30 min (0, 2, 5, 10, 15, 20, and 30 min)
AUC0-∞ of Budesonide With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
AUC0-∞ of Formoterol With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Tmax for Budesonide With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Tmax for Formoterol With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
t1/2 for Budesonide With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
t1/2 for Formoterol With and Without Charcoal Blockade
Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: At 75 min (1.25 hours) post-dose
Change From Baseline in the Ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC)
Time frame: At 75 min (1.25 hours) post-dose
Change From Baseline in Peak Expiratory Flow Rate (PEFR)
Time frame: At 75 min (1.25 hours) post-dose

Results and safety

Results posted to the registry on 26 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A-B1-B2-C-D	9	9
B1-C-A-D-B2	10	8
C-D-B1-B2-A	9	9
D-B2-C-A-B1	9	9
B2-A-D-B1-C	9	8
D-C-B2-B1-A	8	8
B2-D-A-C-B1	9	9
A-B2-B1-D-C	9	8
B1-A-C-B2-D	10	9
C-B1-D-A-B2	9	9

Primary outcome: AUC0-last of Budesonide With and Without Charcoal Blockade

Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min). Geometric mean (Geometric Coefficient of Variation). Unit: pg*h/mL

Measure	Treatment A n = 87	Treatment B n = 172	Treatment C n = 86	Treatment D n = 86
Value	1710 (17.9)	1710 (33.1)	1570 (20.2)	1530 (39.7)

Treatment A vs Treatment B: Adjusted geometric means ratio: 100.64 (90% CI 95.82 to 105.69), p <0.001, Mixed Models Analysis
Treatment C vs Treatment D: Adjusted geometric means ratio: 102.11 (90% CI 95.55 to 109.13), p <0.001, Mixed Models Analysis

Population analysed: PK population included subjects who had received both test and reference for at least one dose of each treatment without or with oral charcoal. Treatment B "Number of Participants" counted for both Symbicort 1 and Symbicort 2 treatment group.

Primary outcome: AUC0-last of Formoterol With and Without Charcoal Blockade

Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min). Geometric mean (Geometric Coefficient of Variation). Unit: pg*h/mL

Measure	Treatment A n = 87	Treatment B n = 172	Treatment C n = 86	Treatment D n = 86
Value	46.1 (22.7)	52.6 (37.3)	39.0 (25.4)	42.8 (50.8)

Treatment A vs Treatment B: Adjusted geometric means ratio: 87.96 (90% CI 83.31 to 92.86), p = 0.002, Mixed Models Analysis
Treatment C vs Treatment D: Adjusted geometric means ratio: 91.17 (90% CI 83.94 to 99.04), p = 0.005, Mixed Models Analysis

Primary outcome: Cmax of Budesonide With and Without Charcoal Blockade

Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min). Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Treatment A n = 87	Treatment B n = 172	Treatment C n = 86	Treatment D n = 86
Value	1080 (69.8)	686 (53.2)	1110 (72.8)	663 (50.6)

Treatment A vs Treatment B: Adjusted geometric means ratio: 157.86 (90% CI 144.12 to 172.91), p = 1.00, Mixed Models Analysis
Treatment C vs Treatment D: Adjusted geometric means ratio: 166.81 (90% CI 148.35 to 187.57), p = 1.00, Mixed Models Analysis

Primary outcome: Cmax of Formoterol With and Without Charcoal Blockade

Time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min). Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Treatment A n = 87	Treatment B n = 172	Treatment C n = 86	Treatment D n = 86
Value	10.1 (37.1)	11.9 (46.1)	10.3 (35.7)	11.7 (50.4)

Treatment A vs Treatment B: Adjusted geometric means ratio: 85.22 (90% CI 79.66 to 91.17), p = 0.012, Mixed Models Analysis
Treatment C vs Treatment D: Adjusted geometric means ratio: 87.74 (90% CI 81.48 to 94.47), p = 0.020, Mixed Models Analysis

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study till the end of trial assessment, that is from the first day of screening up to 6 weeks.. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 88 (0%)	15 of 88 (17%)	0 of 88
Treatment B	0 of 91 (0%)	22 of 91 (24.2%)	0 of 91
Treatment C	0 of 86 (0%)	13 of 86 (15.1%)	0 of 86
Treatment D	0 of 87 (0%)	11 of 87 (12.6%)	0 of 87

Limitations and caveats (from the sponsor): Limitations and Caveats not specified

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Sharan Sidhu, MBChB principal investigator

Quotient Clinical Limited

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?

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 23 Feb 2022. 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?

Yes. Results are posted in the registry (first posted 26 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUC0-last of Budesonide With and Without Charcoal Blockade (time frame: 0-24h (0, 2, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 1440 min)). The study lists 4 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 NCT02631941.

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 23 Feb 2022.