Bronchial AsthmaPhase 3NCT02624505
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
A Phase 3 study testing 90 mcg Reference Product, 180 mcg Reference Product and 90 mcg Test Product in people with Bronchial Asthma, run by Cipla Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- 90 mcg Reference Product, 180 mcg Reference Product and 90 mcg Test Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Nov 2016
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant female subjects (18-65 years of age)
- Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
- Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
- Written informed consent.
Who cannot join
- Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.
- History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
- History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
- History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma
- Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases
- Known intolerance or hypersensitivity or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230
About this study
Official title: To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
Read the detailed description
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
- Conditions
- Bronchial Asthma
- Being tested
- 90 mcg Reference Product, 180 mcg Reference Product, 90 mcg Test Product, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90 mcg Reference ProductDrug
Also called Albuterol
Drug: 90 mcg Reference Product
180 mcg Reference ProductDrug
Also called Albuetrol
Drug: 180 mcg of Reference Product
90 mcg Test ProductDrug
Also called Albuterol
Drug: 90 mcg of Test Product
PlaceboDrug
Placebo Product
| Study group | Role | What they receive |
|---|---|---|
| Placebo Product | Placebo comparator | One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols Receives: Drug: Placebo |
| 90 mcg Reference Product | Active comparator | Drug : 90 mcg Reference Product One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols Receives: Drug: 90 mcg Reference Product |
| 180 mcg Reference Product | Active comparator | Drug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols Receives: Drug: 180 mcg Reference Product |
| 90 mcg Test Product | Experimental | Drug: 90 mcg Test Product One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols Receives: Drug: 90 mcg Test Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cipla Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dhiraj Abhyankar, Study chair, Cipla Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624505
- Sponsor's protocol ID
- U-SS-M-AS312
- Status last verified
- Jul 2019
- First submitted
- 4 Dec 2015
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Undecided
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
- To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.
- ClinicalTrials.gov ID
- NCT02624505
- Acronym / sponsor ID
- U-SS-M-AS312
- Conditions
- Bronchial Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cipla Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Dec 2015 (estimated)
- 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.
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
Detailed description
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Product | Placebo comparator | Drug: PlaceboOne actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols |
| 90 mcg Reference Product | Active comparator | Drug: 90 mcg Reference ProductDrug : 90 mcg Reference Product One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols |
| 180 mcg Reference Product | Active comparator | Drug: 180 mcg Reference ProductDrug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols |
| 90 mcg Test Product | Experimental | Drug: 90 mcg Test ProductDrug: 90 mcg Test Product One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and non-pregnant female subjects (18-65 years of age)
- Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
- Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
- Written informed consent.
Key exclusion criteria (6 listed)
- Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.
- History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
- History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
- History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma
- Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases
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 |
|---|---|---|
| 90 mcg Reference ProductAlso: AlbuterolDrug: 90 mcg Reference Product | Drug | 90 mcg Reference Product |
| 180 mcg Reference ProductAlso: AlbuetrolDrug: 180 mcg of Reference Product | Drug | 180 mcg Reference Product |
| 90 mcg Test ProductAlso: AlbuterolDrug: 90 mcg of Test Product | Drug | 90 mcg Test Product |
| PlaceboPlacebo Product | Drug | Placebo Product |
Primary outcome
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)
Time frame: 1 day
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.
- Individual participant dataSharing planned: No. Undecided
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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.
Dhiraj Abhyankar study chair
Cipla Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 90 mcg Reference Product, 180 mcg Reference Product and 90 mcg Test Product in people with Bronchial Asthma, run by Cipla Ltd. at 1 site in United States.
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 5 inclusion and 6 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 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.