Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of cumulative doses of Albuterol ...
Eligibility Criteria
Inclusion
- 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 \<80% predicted normal value after withholding SABA ≥6 hours
- Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
- Only 2 reversibility testing attempts are allowed
Exclusion
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- Oral corticosteroid use (any dose) within 6 weeks
- Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol
- Current smokers, former smokers with \>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
Key Trial Info
Start Date :
December 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03371459
Start Date
December 29 2017
End Date
March 26 2018
Last Update
July 23 2019
Active Locations (5)
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1
Research Site
Winter Park, Florida, United States, 32789
2
Research Site
North Dartmouth, Massachusetts, United States, 02747
3
Research Site
St Louis, Missouri, United States, 63141
4
Research Site
Raleigh, North Carolina, United States, 27607