Bronchial AsthmaPhase 3NCT06154304
BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma
A Phase 3 study testing Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation), Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 and Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2 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?
- Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation), Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 and Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to 29 Nov 2024
- 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
- Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)
- Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC
- If a subject's FEV1 at the pre-challenge (baseline/Pre-saline) spirometry is <80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days)
- Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC
- Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.
Who cannot join
- 1. Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC. 2. Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.
- -
Trial locations and contacts
1 site in 1 country.
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
- Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation), Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1, Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)Drug
Also called Albuterol Test Product
90 mcg
Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1Drug
Also called Albuterol Reference Product
90 mcg
Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2Drug
Also called Albuterol Reference Product
180 mcg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo Product | Placebo comparator | One actuation each from four different placebo inhalation aerosols. Receives: Drug: Placebo |
| Test Product | Experimental | One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols Receives: Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) |
| Reference 90mcg Product | Active comparator | One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols. Receives: Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 |
| Reference 180mcg Product | Active comparator | One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo inhalation aerosols Receives: Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)
- To compare the bronchoprotective effects of the test product, Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) [InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River - MA02720] with the Reference product, Ventolin HFA (Albuterol sulfate inhalation aerosol) 90 mcg per actuation (GlaxoSmithKline, USA), as assessed by methacholine bronchoprovocation challenge (MBPC) testing
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 posted4 Dec 2023
- Study start6 Dec 2023
- Primary completion16 Sep 2024
- Study completion29 Nov 2024
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cipla Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Smiley, Principal investigator, Velocity Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154304
- Sponsor's protocol ID
- CRD/58
- Status last verified
- Jul 2025
- First submitted
- 23 Nov 2023
- Last updated
- 16 Jul 2025
- 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 16 Jul 2025. 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
- NCT06154304
- Acronym / sponsor ID
- CRD/58
- Conditions
- Bronchial Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cipla Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 4 Dec 2023 (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.
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 four different placebo inhalation aerosols. |
| Test Product | Experimental | Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols |
| Reference 90mcg Product | Active comparator | Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols. |
| Reference 180mcg Product | Active comparator | Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo 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)
- Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)
- Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC
- Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC
- Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.
Key exclusion criteria (2 listed)
- 1. Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC. 2. Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.
- -
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 |
|---|---|---|
| Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)Also: Albuterol Test Product90 mcg | Drug | Test Product |
| Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1Also: Albuterol Reference Product90 mcg | Drug | Reference 90mcg Product |
| Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2Also: Albuterol Reference Product180 mcg | Drug | Reference 180mcg Product |
| PlaceboPlacebo | Drug | Placebo Product |
Primary outcome
Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)
Time frame: 1 day
• To compare the bronchoprotective effects of the test product, Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) [InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River - MA02720] with the Reference product, Ventolin HFA (Albuterol sulfate inhalation aerosol) 90 mcg per actuation (GlaxoSmithKline, USA), as assessed by methacholine bronchoprovocation challenge (MBPC) testing
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 16 Jul 2025.
- 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.
Sarah Smiley principal investigator
Velocity Clinical Research
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 Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation), Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 and Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2 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 2 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 16 Jul 2025. 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 Dose of Methacholine Causing 20 % Fall (PD20) 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 16 Jul 2025.