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

Launched by GLAXOSMITHKLINE · Sep 20, 2012

Keywords

ClinConnect Summary

Beta2-agonist and anticholinergics are a principle component of the pharmacologic management of chronic obstructive pulmonary disease COPD. It has been demonstrated that the combination of a short acting beta2-agonist and a short acting anticholinergic yields greater efficacy as measured by FEV1 when compared with the response to the individual short acting bronchodilators. However, daily bronchial response to these agents is poorly understood. It is also poorly understood how the variation in magnitude of the response to the individual agents and how the variation in response for one agent...

Gender

ALL

Eligibility 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