Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT03549897
- Run by
- Amneal Ireland Limited
- People needed
- 100
- Starts
- 2018-03-16
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2018-06-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Amneal Pharmaceuticals LLC — Brookhaven, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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