AsthmaPhase 3NCT03549897
Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base
A Phase 3 study testing 90 mcg Reference Product, 180 mcg Reference Product and 90 mcg Test Product in people with Asthma, run by Amneal Ireland Limited at 1 site in United States.
Trial summary
This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2018to Sep 2018
- 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).
- Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- FEV1 ≥ 80% of predicted.
- Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
- Nonsmokers for at least six 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
- Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
- History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
- History of cystic fibrosis, bronchiectasis or other respiratory diseases.
- History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
- Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
- Known intolerance or hypersensitivity to any component of the albuterol MDI.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Amneal Pharmaceuticals LLC
Brookhaven, New York, 11719
Irshad Haque, 631-952-0214, ihaque@amneal.com
About this study
Official title: A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Amneal Ireland Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Patients With Stable, Mild Asthma
This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.
- Conditions
- Asthma
- Being tested
- Placebo, 90 mcg Reference Product, 180 mcg Reference Product, 90 mcg Test Product
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo Product
90 mcg Reference ProductDrug
Also called Albuterol
90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
180 mcg Reference ProductDrug
Also called Albuterol
180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
90 mcg Test ProductDrug
Also called Albuterol
90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED]
| 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 | 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 | One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols Receives: Drug: 180 mcg Reference Product |
| 90 mcg Test Product | Experimental | 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.
Primary Pharmacodynamic Endpoint Post-dose PC20
Provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol or placebo by inhalation. The 20% reduction in FEV1 will be determined relative to the post-saline FEV1 measure before the placebo or albuterol administration.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start16 Mar 2018
- Primary completionAug 2018 (estimated)
- Study completionSep 2018 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amneal Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irshad Haque, Study director, Amneal Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549897
- Sponsor's protocol ID
- AI-ABL-001
- Status last verified
- Jun 2018
- First submitted
- 6 Apr 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Amneal Ireland Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Patients With Stable, Mild Asthma
- ClinicalTrials.gov ID
- NCT03549897
- Acronym / sponsor ID
- AI-ABL-001
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amneal Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 8 Jun 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 randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in 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 ProductOne 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 ProductOne actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols |
| 90 mcg Test Product | Experimental | Drug: 90 mcg Test ProductOne 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 (6 listed)
- Male and non-pregnant female subjects (18-65 years of age).
- Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- FEV1 ≥ 80% of predicted.
- Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
- Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
Key exclusion criteria (6 listed)
- Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
- History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
- History of cystic fibrosis, bronchiectasis or other respiratory diseases.
- History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
- Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
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 |
|---|---|---|
| PlaceboPlacebo Product | Drug | Placebo Product |
| 90 mcg Reference ProductAlso: Albuterol90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC] | Drug | 90 mcg Reference Product |
| 180 mcg Reference ProductAlso: Albuterol180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC] | Drug | 180 mcg Reference Product |
| 90 mcg Test ProductAlso: Albuterol90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED] | Drug | 90 mcg Test Product |
Primary outcome
Primary Pharmacodynamic Endpoint Post-dose PC20
Time frame: 6 weeks
Provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol or placebo by inhalation. The 20% reduction in FEV1 will be determined relative to the post-saline FEV1 measure before the placebo or albuterol administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Irshad Haque study director
Amneal Pharmaceuticals, LLC
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 Asthma, run by Amneal Ireland Limited 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 6 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: status not confirmed, as of the sponsor's last update on 14 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irshad Haque (631-952-0214, ihaque@amneal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Pharmacodynamic Endpoint Post-dose PC20 (time frame: 6 weeks). 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 14 Jun 2018.