Phase 2
Completed N=140
PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
Source: ClinicalTrials.gov NCT01566773 ↗Enrolled (actual)
140
Serious AEs
1.0%
Results posted
Oct 2017
Primary outcomePrimary: FEV1 AUC0-12 — 1.448; 1.416; 1.432; 1.416 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 |
1.448; 1.416; 1.432; 1.416; 1.386; 1.353 | — |
| SECONDARY Peak Change From Baseline in FEV1 |
288; 288; 287; 261; 246; 188 | — |
| SECONDARY Time to Onset of Action (>10% Improvement in FEV1) on Day 1 |
29; 30; 14; 21; 18; 7 | — |
| SECONDARY Percentage of Subjects Achieving at Least 12% Improvement in FEV1 |
70; 59; 40; 47; 40; 31 | — |
| SECONDARY Peak Change From Baseline in Inspiratory Capacity (IC) |
234; 263; 151; 183; 126; 82 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Trough FEV1 |
89; 80; 67; 77; 68; 29 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC) |
137; 57; 101; 142; 73; 54 | — |
| SECONDARY Peak Change From Baseline in IC |
280; 259; 288; 226; 261; 172 | — |
| SECONDARY Change From Baseline in Mean Morning Pre-dose Daily PEFR |
8.6; 6.2; 2.0; 4.4; 0.3; -0.5 | — |
| SECONDARY Change From Baseline in Morning Post-dose Daily PEFR |
32.3; 23.9; 17.2; 18.3; 14.3; 13.7 | — |
| SECONDARY Change From Baseline in Mean Evening Pre-dose PEFR |
15.8; 12.6; 4.7; 11.2; 7.5; 5.9 | — |
| SECONDARY Change From Baseline in Mean Evening Post-dose PEFR |
42.2; 30.3; 21.6; 24.3; 20.2; 22.1 | — |
| SECONDARY Mean Number of Puffs of Rescue Medication |
0.9; 1.3; 1.2; 1.2; 1.5; 1.6 | — |
| SECONDARY Change From Baseline for Mean Morning Pre-dose Trough IC |
94; 45; 64; 104; 69; 34 | — |
| SECONDARY Change From Baseline in 12-hour Post-dose Trough FEV1 |
116; 69; 99; 112; 66; 55 | — |
| SECONDARY Change From Baseline in Mean Morning Post-dose Daily PEFR |
33.5; 26.7; 20.2; 20.3; 14.8; 14.3 | — |
| SECONDARY Change From Baseline in Mean Evening Pre-dose Daily PEFR |
15.7; 14.9; 7.2; 11.7; 5.0; 6.9 | — |
| SECONDARY Change From Baseline in Mean Evening Post-dose Daily PEFR |
41.4; 32.7; 24.7; 27.0; 19.4; 22.7 | — |
| SECONDARY Mean Number of Puffs of Rescue Medication (End of Treatment) |
0.85; 1.25; 1.19; 1.11; 1.43; 1.57 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14 |
0.088; 0.087; 0.090; 0.086; 0.056; 0.023 | — |
Eligibility Criteria
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
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 (NCT01566773). 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.