A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium

• Status: Completed
• Trial end date: 2012-10-22
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the daily variation in bronchodilator response to an inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting anticholinergic (ipratropium) individually and when used in combination in subjects with COPD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Albuterol; Ipratropium

Criteria

Inclusion Criteria:

• Subjects must give their signed and dated written informed consent to participate.

• Subjects 40 years of age or older at Visit 1.

• Male or female subjects .

• An established clinical history of COPD.

• Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Visit 1.

• A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of >=30 and <= 70% of predicted normal values at Visit 1 calculated using NHANES III reference equations .

Exclusion Criteria:

• A current diagnosis of asthma

• Women who are pregnant of lactating or are planning on becoming pregnant during the study.

• Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.

• Participation in pulmonary rehabilitation