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

Completed · Phase 4

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT01691482

Run by

GlaxoSmithKline

People needed

56

Starts

2012-07-23

Expected to finish

2012-10-22

Last updated by the study team

2018-06-20

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 .

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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