Recruiting
Phase 3

Albuterol Sulfate

Sponsor:

Amneal Ireland Limited

Code:

NCT03549897

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Placebo

90 mcg Reference Product

180 mcg Reference Product

90 mcg Test Product

Study Details

Brief 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 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

Study ID

NCT03549897

Start date

Mar 16, 2018

Status verified date

Jun, 2018

Completion date

Sep, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Product

One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols

active comparator: 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

active comparator: 180 mcg Reference Product

One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols

experimental: 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

Interventions

Placebo

Placebo Product

90 mcg Reference Product

90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]

180 mcg Reference Product

180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]

90 mcg Test Product

90 mcg Test Product - ALBUTEROL SULFATE HFA \[AMNEAL IRELAND LIMITED\]

Primary outcome measure

  • Primary Pharmacodynamic Endpoint Post-dose PC20 [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Irshad Haque

631-952-0214ihaque@amneal.com

Locations

Amneal Pharmaceuticals LLC

Recruiting

Brookhaven, New York, United States, 11719

Contacts

Irshad Haque

631-952-0214ihaque@amneal.com

More Information

Sponsor

Amneal Ireland Limited

Last update posted

Jun 14, 2018

Last verified

Jun, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amneal Ireland Limited on 2018-06-14.