AsthmaPhase 3NCT03528577

A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)

A Phase 3 study testing Zero-dose, 90 mcg of PROAIR® HFA and 180 mcg of 90 mcg of PROAIR® HFA in people with Asthma, run by Sun Pharmaceutical Industries Limited at 8 sites in United States.

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

To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: Zero-dose, 90 mcg of PROAIR® HFA and 180 mcg of 90 mcg of PROAIR® HFA
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 8 sitesUnited States
Study dates: 22 Sep 2018to 3 Aug 2019
Phase: Phase 3
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or non-pregnant women 18 to 65 years of age.
Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.
Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test
Ability to use inhalation aerosol correctly.

Who cannot join

Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.
Employees of the Investigator or research center or their immediate family members.
Previous participation in this study.
Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

SPARC site 01
Bethesda, Maryland, 20814
SPARC Site 08
Boerne, Texas, 78006
SPARC Site 05
Edmond, Oklahoma, 73034
SPARC Site 06
Gastonia, North Carolina, 28054
SPARC Site 02
Miami Lakes, Florida, 33014
SPARC Site 04
St Louis, Missouri, 63141
SPARC Site 03
Waco, Texas, 76712
SPARC Site 07
Warwick, Rhode Island, 02886

Other trials in United States

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 (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma

Conditions: Asthma
Being tested: Zero-dose, 90 mcg of PROAIR® HFA, 180 mcg of 90 mcg of PROAIR® HFA, 90 mcg of albuterol sulfate inhalation aerosol
Medical subject headings: Asthma

What participants receive

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

Zero-doseDrug
Treatment A
90 mcg of PROAIR® HFADrug
Treatment B
180 mcg of 90 mcg of PROAIR® HFADrug
Treatment C
90 mcg of albuterol sulfate inhalation aerosolDrug
Treatment D

Study groups in NCT03528577
Study group	Role	What they receive
Test	Experimental	Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Receives: Drug: Zero-dose; Drug: 90 mcg of PROAIR® HFA; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Drug: 90 mcg of albuterol sulfate inhalation aerosol
Reference	Active comparator	PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg Receives: Drug: Zero-dose; Drug: 90 mcg of PROAIR® HFA; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Drug: 90 mcg of albuterol sulfate inhalation aerosol
Test Placebo	Placebo comparator	Placebo for Albuterol Sulfate Inhalation Aerosol Receives: Drug: Zero-dose; Drug: 90 mcg of PROAIR® HFA; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Drug: 90 mcg of albuterol sulfate inhalation aerosol
Reference Placebo	Placebo comparator	Placebo for Albuterol Sulfate Inhalation Aerosol Receives: Drug: Zero-dose; Drug: 90 mcg of PROAIR® HFA; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Drug: 90 mcg of albuterol sulfate inhalation aerosol

What is being measured

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

Pharmacodynamic Endpoint Post-dose PC20
The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation.
Primary analysis group -pharmacodynamic population.
Measured: Approximately 15 minutes after last inhalation of study product

Timeline

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

22 Sep 20183 Aug 2019

First posted18 May 2018
Study start22 Sep 2018
Primary completion11 Mar 2019
Study completion3 Aug 2019

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.
More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03528577
Sponsor's protocol ID: CLR_17_08
Status last verified: Jan 2021
First submitted: 21 Apr 2018
Last updated: 22 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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?

See locations

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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
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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. 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 (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
ClinicalTrials.gov ID: NCT03528577
Acronym / sponsor ID: CLR_17_08
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
Study start: 22 Sep 2018 (actual)
Primary completion: 11 Mar 2019 (actual)
Study completion: 3 Aug 2019 (actual)
First posted: 18 May 2018 (actual)
Results: Posted 22 Jan 2021

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Test	Experimental	Drug: Zero-dose, Drug: 90 mcg of PROAIR® HFA, Drug: 180 mcg of 90 mcg of PROAIR® HFA, Drug: 90 mcg of albuterol sulfate inhalation aerosolAlbuterol Sulfate Inhalation Aerosol, eq 90 mcg
Reference	Active comparator	Drug: Zero-dose, Drug: 90 mcg of PROAIR® HFA, Drug: 180 mcg of 90 mcg of PROAIR® HFA, Drug: 90 mcg of albuterol sulfate inhalation aerosolPROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
Test Placebo	Placebo comparator	Drug: Zero-dose, Drug: 90 mcg of PROAIR® HFA, Drug: 180 mcg of 90 mcg of PROAIR® HFA, Drug: 90 mcg of albuterol sulfate inhalation aerosolPlacebo for Albuterol Sulfate Inhalation Aerosol
Reference Placebo	Placebo comparator	Drug: Zero-dose, Drug: 90 mcg of PROAIR® HFA, Drug: 180 mcg of 90 mcg of PROAIR® HFA, Drug: 90 mcg of albuterol sulfate inhalation aerosolPlacebo for Albuterol Sulfate Inhalation Aerosol

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men or non-pregnant women 18 to 65 years of age.
Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.
Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test
Ability to use inhalation aerosol correctly.

Key exclusion criteria (4 listed)

Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.
Employees of the Investigator or research center or their immediate family members.
Previous participation in this study.
Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

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
Zero-doseTreatment A	Drug	Reference, Reference Placebo, Test, Test Placebo
90 mcg of PROAIR® HFATreatment B	Drug	Reference, Reference Placebo, Test, Test Placebo
180 mcg of 90 mcg of PROAIR® HFATreatment C	Drug	Reference, Reference Placebo, Test, Test Placebo
90 mcg of albuterol sulfate inhalation aerosolTreatment D	Drug	Reference, Reference Placebo, Test, Test Placebo

Primary outcome

Pharmacodynamic Endpoint Post-dose PC20
Time frame: Approximately 15 minutes after last inhalation of study product
The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population.

Results and safety

Results posted to the registry on 22 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total	128	126

Primary outcome: Pharmacodynamic Endpoint Post-dose PC20

Time frame: Approximately 15 minutes after last inhalation of study product. Mean (90% Confidence Interval). Unit: mg/mL

Measure	Primary Analysis Group n = 126
Value	114 (52.8 to 162.0)

Population analysed: The statistical analysis was performed based on the Dose-Scale approach. This approach was referenced in FDA's draft Guidance on albuterol sulfate metered/inhalation and described in FDA's draft Guidance on Orlistat capsule. The PC20 data from various treatments (such as placebo, 90 mcg Test, 90 mcg Reference and 180 mcg Reference) from different study period was pooled to perform the Dose-Scale model using NONMEM. Therefore, per test arm values were not reported.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 125 (0%)	7 of 125 (5.6%)	0 of 125
Treatment B	0 of 125 (0%)	3 of 125 (2.4%)	0 of 125
Treatment C	0 of 123 (0%)	9 of 123 (7.3%)	0 of 123
Treatment D	0 of 126 (0%)	5 of 126 (4%)	0 of 126

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Asthma

RecruitingPhase 1
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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.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zero-dose, 90 mcg of PROAIR® HFA and 180 mcg of 90 mcg of PROAIR® HFA in people with Asthma, run by Sun Pharmaceutical Industries Limited at 8 sites 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 4 inclusion and 4 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

Yes. Results are posted in the registry (first posted 22 Jan 2021). 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?

Pharmacodynamic Endpoint Post-dose PC20 (time frame: Approximately 15 minutes after last inhalation of study product). 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 NCT03528577.

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 22 Jan 2021.