Status:
COMPLETED
Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol ...
Detailed Description
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3-...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Are at least 12 years of age and no older than 65 years
- 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 ≥40 to \<90% predicted normal value after withholding SABA for ≥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 Criteria:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2018
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03364608
Start Date
December 15 2017
End Date
March 30 2018
Last Update
July 24 2019
Active Locations (10)
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1
Research Site
Rolling Hills Estates, California, United States, 90274
2
Research Site
Stockton, California, United States, 95207
3
Research Site
Winter Park, Florida, United States, 32789
4
Research Site
North Dartmouth, Massachusetts, United States, 02747