Phase 2
N=159
Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01587079 ↗Enrolled (actual)
159
Serious AEs
1.1%
Results posted
Jun 2016
Primary outcome: Primary: FEV1 AUC 0-12 on Day 7 — 1.452; 1.591; 1.547; 1.539 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PT003 (Drug); PT001 (Drug); PT005 (Drug); Tiotropium inhalation powder (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pearl Therapeutics, Inc.
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 AUC 0-12 on Day 7 |
1.452; 1.591; 1.547; 1.539; 1.538; 1.508 | — |
| SECONDARY Peak Change From Baseline in FEV1 on Treatment Day 1 |
209; 339; 329; 348; 333; 312 | — |
| SECONDARY Time to Onset of Action (>10% Improvement in FEV1) on Day 1 |
27; 65; 51; 62; 65; 66 | — |
| SECONDARY Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1 |
56; 93; 85; 84; 86; 83 | — |
| SECONDARY Peak Change From Baseline in Inspiratory Capacity on Day 1 |
204; 393; 320; 387; 347; 348 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7 |
120; 183; 150; 154; 163; 130 | — |
| SECONDARY Peak Change From Baseline in FEV1 on Day 7 |
300; 444; 414; 403; 388; 363 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Trough IC on Day 7 |
109; 185; 183; 215; 203; 151 | — |
| SECONDARY Peak Change From Baseline IC on Day 7 |
223; 430; 441; 409; 368; 371 | — |
| SECONDARY Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7 |
99; 196; 162; 118; 133; 110 | — |
| SECONDARY Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7 |
7.6; 25.2; 16.6; 12.4; 18.0; 13.8 | — |
| SECONDARY Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7 |
31.0; 58.8; 55.0; 46.7; 52.1; 49.6 | — |
| SECONDARY Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7 |
11.7; 32.5; 25.0; 19.0; 25.6; 19.9 | — |
| SECONDARY Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7 |
35.0; 61.5; 56.1; 51.5; 53.7; 53.8 | — |
Summary
The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD
Eligibility Criteria
Key Inclusion Criteria
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- A measured post-bronchodilator FEV1/FVC ratio of or = 750ml or 30% predicted and < or = 80% of predicted normal values
- Able to change COPD treatment as required by protocol
Key Exclusion Criteria
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
- Abnormal chest X-ray not due to the presence of COPD
- Hospitalized due to poorly controlled COPD within 3 months of Screening
- Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
- Cancer that has not been in complete remission for at least 5 years
- Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
Other inclusion/exclusion criteria as defined in the protocol
Data sourced from ClinicalTrials.gov (NCT01587079). 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.