Phase 3
N=1,756
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT02343458 ↗Enrolled (actual)
1,756
Serious AEs
8.4%
Results posted
Feb 2019
Primary outcome: Primary: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach) — 120; 47; 60; -45 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GFF MDI (PT003) (Drug); FF MDI (PT005) (Drug); GP MDI (PT001) (Drug); Placebo MDI (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pearl Therapeutics, Inc.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach) |
120; 47; 60; -45 | — |
| PRIMARY Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach |
128; 54; 74; -25 | — |
| PRIMARY Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach. |
135; 63; 80; -20 | — |
| SECONDARY TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach |
1.6; 1.5; 1.3; 0.8 | — |
| SECONDARY TDI Focal Score Over Weeks 12-24 Japan Approach |
1.7; 1.5; 1.4; 0.8 | — |
| SECONDARY TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population |
1.5; 1.3; 1.1; 0.7 | — |
| SECONDARY TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population |
1.5; 1.4; 1.1; 0.7 | — |
| SECONDARY Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach |
358; 247; 214; 55 | — |
| SECONDARY Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach |
368; 255; 228; 70 | — |
| SECONDARY Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach |
375; 277; 234; 82 | — |
| SECONDARY Change From Baseline in SGRQ Total Score at Week 24, US/China Approach |
-5.3; -5.6; -3.7; -0.9 | — |
| SECONDARY Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach |
-5.2; -5.0; -3.6; -1.7 | — |
| SECONDARY Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach |
-6.9; -7.8; -3.8; -1.6 | — |
| SECONDARY Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach |
-6.9; -7.3; -3.9; -3.1 | — |
| SECONDARY Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches |
-1.4; -1.0; -0.6; -0.4 | — |
| SECONDARY FEV1 Measured at 5 Minutes Post-dose on Day 1 |
0.202; 0.186; 0.059; 0.022 | — |
| SECONDARY FEV1 Measured at 15 Minutes Post-dose on Day 1 |
0.241; 0.220; 0.105; 0.033 | — |
Summary
A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.
Eligibility Criteria
Inclusion Criteria
- Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.
- FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).
Exclusion Criteria
- Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
- Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
Data sourced from ClinicalTrials.gov (NCT02343458). 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.