Phase 2
Completed N=86
Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
Source: ClinicalTrials.gov NCT03364608 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in FEV1 AUC0-6 — 0.266; 0.203; 0.282; 0.240 Liters
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 Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in FEV1 AUC0-6 |
0.266; 0.203; 0.282; 0.240; 0.070 | — |
| SECONDARY Change From Baseline in FEV1 AUC0-4 |
0.331; 0.263; 0.349; 0.297; 0.080 | — |
| SECONDARY Peak Change From Baseline in FEV1 |
0.509; 0.433; 0.516; 0.472; 0.233 | — |
Eligibility Criteria
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 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 (NCT03364608). 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. Informational only — not medical advice.