Phase 3
Completed N=1,071
Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
Source: ClinicalTrials.gov NCT03358147 ↗Enrolled (actual)
1,071
Serious AEs
2.9%
Results posted
Aug 2020
Primary outcomePrimary: 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
◆ Published Evidence
Established
21citations · ~5 / year
Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis.
Summary
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
Linked Publications
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Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis.
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 | — |
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) and the linked publication. 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.