Phase 2
Completed N=176
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00950807 ↗
Enrolled (actual)
176
Serious AEs
0.6%
Results posted
Mar 2014
Primary outcomePrimary: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period — -0.047; 0.081; 0.099; 0.048 Liters — p=<0.001
Summary
The study will evaluate the dose response, 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 15 of Each Treatment Period |
-0.047; 0.081; 0.099; 0.048; 0.092; 0.138 | <0.001 sig |
| SECONDARY Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period |
-0.059; 0.085; 0.077; 0.077; 0.072; 0.080 | — |
| SECONDARY Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period |
-0.002; 0.140; 0.101; 0.167; 0.095; 0.120 | — |
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 35 to 70% of predicted normal
Exclusion Criteria
- Asthma
- Other significant respiratory disorders besides COPD, including alpha-1 deficiency
- Previous lung resection surgery
- 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, Holter, or clinical lab finding (including Hepatitis B or C)
- Cancer
- Allergy or hypersensitivity to anticholinergics or inhaler excipients
- Diseases that would contra-indicate 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
- Previous use of GSK573719
Data sourced from ClinicalTrials.gov (NCT00950807). 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.