GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00950807
• Date of registration: 30/07/2009
• Primary sponsor: GlaxoSmithKline
• Public title: GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects With COPD
• Date of first enrolment: September 2009
• Target sample size: 176
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00950807
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Germany, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Bronchitis

Chronic Obstructive Pulmonary Disease (COPD)

Emphysema

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: GSK573179

Drug: Placebo

Drug: Tiotropium

Primary Outcome(s)

Pre-dose (trough) forced expiratory volume in one second (FEV1) [Time Frame: 15 days]

Secondary Outcome(s)

24 hour Holter monitoring [Time Frame: 15 days]

Adverse events [Time Frame: 15 days]

Albuterol use [Time Frame: 15 days]

Clinical chemistry, haematology, and urinalysis assessments [Time Frame: 15 days]

ECG measures [Time Frame: 15 days]

Serial FEV1 over 28 hours [Time Frame: 15 days]

Vital signs [Time Frame: 15 days]

Weighted mean FEV1 over 24 hours [Time Frame: 15 days]

Secondary ID(s)

113073

Source(s) of Monetary Support

Please refer to primary and secondary sponsors