Phase 2
Completed N=185
PT003 MDI Dose Confirmation Study
Source: ClinicalTrials.gov NCT01349816 ↗Enrolled (actual)
185
Serious AEs
0.9%
Results posted
Apr 2017
Primary outcomePrimary: FEV1 AUC0-12 — 1.467; 1.462; 1.493; 1.499 Liters
Summary
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 AUC0-12 |
1.467; 1.462; 1.493; 1.499; 1.399; 1.465 | — |
| SECONDARY Peak Change From Baseline in FEV1 |
0.312; 0.308; 0.344; 0.350; 0.248; 0.307 | — |
| SECONDARY Time to Onset of Action |
28; 21; 20; 30; 15; 24 | — |
| SECONDARY At Least 12% Improvement in FEV1 |
22; 17; 18; 27; 13; 22 | — |
| SECONDARY Peak Change in IC |
0.323; 0.242; 0.339; 0.326; 0.228; 0.316 | — |
| SECONDARY Morning Pre-dose FEV1 |
0.152; 0.110; 0.122; 0.131; 0.100; 0.103 | — |
| SECONDARY FEV1 Through 6 Hours |
0.362; 0.356; 0.388; 0.415; 0.283; 0.355 | — |
| SECONDARY Peak Change From Baseline in IC |
0.333; 0.267; 0.340; 0.351; 0.228; 0.354 | — |
| SECONDARY Mean Evening Trough FEV1 |
0.080; 0.073; 0.105; 0.112; 0.081; 0.120 | — |
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 (NCT01349816). 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.