Phase 2
Completed N=103
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01350128 ↗Enrolled (actual)
103
Serious AEs
0.7%
Results posted
Jun 2017
Primary outcomePrimary: FEV1 AUC0-12 — 1.477; 1.497; 1.443; 1.514 Liter
Summary
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 AUC0-12 |
1.477; 1.497; 1.443; 1.514; 1.465; 1.323 | — |
| SECONDARY Peak Change From Baseline in FEV1 on Day 1 |
0.245; 0.221; 0.181; 0.204; 0.250; 0.071 | — |
| SECONDARY Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1 |
32; 31; 19; 25; 48; 7 | — |
| SECONDARY Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1 |
66.67; 58.70; 52.27; 60.98; 77.78; 17.39 | — |
| SECONDARY Peak Change From Baseline in IC on Day 1 |
0.240; 0.276; 0.185; 0.187; 0.252; 0.040 | — |
| SECONDARY Change From Baseline in Morning Pre-dose FEV1 on Day 7 |
0.088; 0.075; 0.010; 0.084; -0.088; -0.043 | — |
| SECONDARY Peak Change From Baseline in FEV1 on Day 7 |
0.242; 0.224; 0.223; 0.238; 0.225; 0.070 | — |
| SECONDARY Peak Change From Baseline in IC on Day 7 |
0.213; 0.189; 0.161; 0.192; 0.191; -0.029 | — |
| SECONDARY Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7 |
0.018; 0.079; 0.004; 0.077; -0.041; -0.054 | — |
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 (or CT scan) 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 (NCT01350128). 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.