Phase 2
N=46
Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03371459 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose — 0.421; 0.488; 0.548; 0.586 Liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AS MDI (Drug); Proventil (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose |
0.421; 0.488; 0.548; 0.586; 0.619; 0.647 | — |
| SECONDARY Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose |
0.561; 0.602 | — |
Summary
This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma
Eligibility Criteria
Inclusion Criteria
- Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
- Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
- Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria
- Pre-bronchodilator FEV1 of ≥50 to 10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
- Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years
- Hospitalized for psychiatric disorder or attempted suicide within 1 year
- Unable to abstain from protocol-defined prohibited medications during the study
Data sourced from ClinicalTrials.gov (NCT03371459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.