Phase 2
Completed N=285
28-day Repeat Dose Study of GSK573719
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01030965 ↗
Enrolled (actual)
285
Serious AEs
1.1%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 — 0.013; 0.171; 0.181; 0.163 Liters — p=<0.001
Summary
The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 |
0.013; 0.171; 0.181; 0.163 | <0.001 sig |
| SECONDARY Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 |
0.005; 0.211; 0.224; 0.173; 0.009; 0.220 | — |
| SECONDARY Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 |
0.013; 0.196; 0.212; 0.145; 0.008; 0.255 | — |
Eligibility Criteria
Inclusion Criteria
- A signed and dated written informed consent prior to study participation
- Males or females of non-childbearing potential
- 40 to 80 years of age
- COPD diagnosis
- 10 pack-years history or greater of cigarette smoking
- Post-bronchodilator FEV1/FVC ratio of 0.70 or less
- Post-bronchodilator FEV1 of 25 to 70% of predicted normal
Exclusion Criteria
- Asthma
- Other significant respiratory disorders besides COPD, including alpha-1 deficiency
- Previous lung resection surgery
- Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
- Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
- Hospitalization for COPD or pneumonia within 3 months of screening
- Any significant disease that would put subject at risk through study participation
- BMI greater than 35
- Pacemaker
- Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C)
- Cancer
- Allergy or hypersensitivity to anticholinergics or inhaler excipients
- Diseases that would contraindicate the use of anticholinergics
- Use of oral corticosteroids within 6 weeks of screening
- Use of long-acting beta-agonists within 48 hours of screening
- Use of tiotropium within 14 days of screening
- Use of theophyllines or anti-leukotrienes within 48 hours of screening
- Use of short-acting bronchodilators within 4 to 6 hours of screening
- Use of investigational medicines within 30 days of screening
- Use of high dose inhaled corticosteroids
- Use of long-term oxygen therapy, CPAP or NIPPV
- Participation in acute phase of pulmonary rehabilitation program
- History of alcohol or drug abuse within 2 years prior to screening
- History of psychiatric disease limiting validity of consent
- Affiliation with the investigative site
- Previous use of GSK573719
Data sourced from ClinicalTrials.gov (NCT01030965). 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.