Phase 3
N=1,071
Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03358147 ↗Enrolled (actual)
1,071
Serious AEs
2.9%
Results posted
Aug 2020
Primary outcome: Primary: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4) — 0.294; 0.284; 0.308; 0.240 Liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GP MDI 28.8 μg (Drug); GP MDI 14.4 μg (Drug); GP MDI 7.2 μg (Drug); Placebo MDI (Drug); Spiriva Respimat 2.5 μg (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Pearl Therapeutics, Inc.
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4) |
0.294; 0.284; 0.308; 0.240; 0.347 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Trough FEV1 |
0.142; 0.108; 0.142; 0.129; 0.150 | — |
| SECONDARY Rate of Moderate to Severe Asthma Exacerbations |
0.43; 0.44; 0.41; 0.55; 0.50 | — |
| SECONDARY Change From Baseline in ACQ-7 (Asthma Control Questionnaire) |
-0.78; -0.73; -0.90; -0.80; -0.90 | — |
| SECONDARY Change From Baseline in ACQ-5 (Asthma Control Questionnaire) |
-0.87; -0.80; -1.02; -0.93; -1.03 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) |
0.89; 0.90; 1.02; 0.96; 1.04 | — |
Summary
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
Eligibility Criteria
Inclusion Criteria
- Have a documented history of physician-diagnosed asthma
- Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA on a stable regimen for at least 4 weeks
- Documented reversibility to albuterol
- A pre-bronchodilator FEV1 >40% and 40% and 10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes, and marijuana)
- Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
- Completed treatment for lower respiratory infection or asthma exacerbation within 4 weeks
- Hospitalizations for asthma within 3 months
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years
- Treatment with investigational study drug (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer
- Previously randomized in any PT001 study
Data sourced from ClinicalTrials.gov (NCT03358147). 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.