Bronchial AsthmaPhase 3NCT05292976
Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation
A Phase 3 study testing Methacholine Chloride, Albuterol Sulfate HFA 0.09 mg (Reference) and Albuterol Sulfate HFA 0.18 mg (Reference) in people with Bronchial Asthma, run by Aurobindo Pharma Ltd at 1 site in United States.
Trial summary
Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg 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?
- Methacholine Chloride, Albuterol Sulfate HFA 0.09 mg (Reference) and Albuterol Sulfate HFA 0.18 mg (Reference)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2022to Dec 2022
- 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 or equivalent PD20.
- 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.
About this study
Official title: Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients
Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg
Read the detailed description
To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH [Aurobindo Pharma, USA, Inc] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation [Teva Pharmaceuticals USA, Inc] in stable mild asthma patients, under Methacholine induced bronchoprovocation.
- Conditions
- Bronchial Asthma
- Being tested
- Methacholine Chloride, Albuterol Sulfate HFA 0.09 mg (Reference), Albuterol Sulfate HFA 0.18 mg (Reference), Albuterol Sulfate HFA 0.09 mg (Test), Albuterol Sulfate HFA 0.18 mg (Test)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine ChlorideOther
Serial Methacholine dilutions
Albuterol Sulfate HFA 0.09 mg (Reference)Drug
Also called Reference single dose
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.
Albuterol Sulfate HFA 0.18 mg (Reference)Drug
Also called Reference double dose
One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
Albuterol Sulfate HFA 0.09 mg (Test)Drug
Also called Test single dose
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.
Albuterol Sulfate HFA 0.18 mg (Test)Drug
Also called Test double dose
One actuation each from two different Test inhalation aerosols and one actuation each from two different placebo Reference inhalation aerosols.
PlaceboDrug
Also called Test and Ref Placebos
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
| Study group | Role | What they receive |
|---|---|---|
| Zero dose: | Placebo comparator | Not described Receives: Other: Methacholine Chloride; Drug: Placebo |
| Reference 0.09 mg | Active comparator | Not described Receives: Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.09 mg (Reference) |
| Reference 0.18 mg | Active comparator | Not described Receives: Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.18 mg (Reference) |
| Test 0.09 mg | Experimental | Not described Receives: Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.09 mg (Test) |
| Test 0.18 mg | Experimental | Not described Receives: Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.18 mg (Test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-dose PD20
Provocative dose of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation.
Measured: Over a period of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Business reasons
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurobindo Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Marialouis, MD, Study director, Aurobindo Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292976
- Sponsor's protocol ID
- CR206-19
- Status last verified
- May 2022
- First submitted
- 15 Mar 2022
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients
- ClinicalTrials.gov ID
- NCT05292976
- Acronym / sponsor ID
- CR206-19
- Conditions
- Bronchial Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aurobindo Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Mar 2022 (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.
Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg
Detailed description
To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH [Aurobindo Pharma, USA, Inc] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation [Teva Pharmaceuticals USA, Inc] in stable mild asthma patients, under Methacholine induced bronchoprovocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Zero dose: | Placebo comparator | Other: Methacholine Chloride, Drug: Placebo |
| Reference 0.09 mg | Active comparator | Other: Methacholine Chloride, Drug: Albuterol Sulfate HFA 0.09 mg (Reference) |
| Reference 0.18 mg | Active comparator | Other: Methacholine Chloride, Drug: Albuterol Sulfate HFA 0.18 mg (Reference) |
| Test 0.09 mg | Experimental | Other: Methacholine Chloride, Drug: Albuterol Sulfate HFA 0.09 mg (Test) |
| Test 0.18 mg | Experimental | Other: Methacholine Chloride, Drug: Albuterol Sulfate HFA 0.18 mg (Test) |
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 or equivalent PD20.
- 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 |
|---|---|---|
| Methacholine ChlorideSerial Methacholine dilutions | Other | Reference 0.09 mg, Reference 0.18 mg, Test 0.09 mg, Test 0.18 mg, Zero dose: |
| Albuterol Sulfate HFA 0.09 mg (Reference)Also: Reference single doseOne actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols. | Drug | Reference 0.09 mg |
| Albuterol Sulfate HFA 0.18 mg (Reference)Also: Reference double doseOne actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols. | Drug | Reference 0.18 mg |
| Albuterol Sulfate HFA 0.09 mg (Test)Also: Test single doseOne actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols. | Drug | Test 0.09 mg |
| Albuterol Sulfate HFA 0.18 mg (Test)Also: Test double doseOne actuation each from two different Test inhalation aerosols and one actuation each from two different placebo Reference inhalation aerosols. | Drug | Test 0.18 mg |
| PlaceboAlso: Test and Ref PlacebosOne actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols. | Drug | Zero dose: |
Primary outcome
Post-dose PD20
Time frame: Over a period of 4 weeks
Provocative dose of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
Related trials for Bronchial Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Joseph Marialouis, MD study director
Aurobindo Pharma 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 Methacholine Chloride, Albuterol Sulfate HFA 0.09 mg (Reference) and Albuterol Sulfate HFA 0.18 mg (Reference) in people with Bronchial Asthma, run by Aurobindo Pharma 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 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: withdrawn, as of the sponsor's last update on 20 May 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Post-dose PD20 (time frame: Over a period of 4 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 20 May 2022.