The effects of 2 bronchodilators on lung function in COPD patients.

• Research type

  Research Study

• Full title

  A 4-Week Randomized Cross-Over Study to Evaluate Daily Lung Function Following the Administration of Albuterol/Salbutamol and Ipratropium in Subjects with Chronic Obstructive Pulmonary Disease.

• IRAS ID

  106570

• Contact name

  Dave Singh

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2012-000384-24

• Research summary

  This study will assess day-to-day changes in how the lungs of patients with Chronic Obstructive Pulmonary Disease (COPD) respond to treatment with salbutamol and ipratropium, which are approved for use in patients with obstructed airways. In COPD, the airways are narrowed, symptoms include cough and severe shortness of breath. Salbuterol and ipratropium are inhaled bronchodilator drugs that work by relaxing and opening up the airways in the lung making it easier to breathe. In this study there will be two groups, in which subjects will receive ether:- 1) salbutamol followed by ipratropium at the clinic visit for the first 10 days, switching to ipratropium followed by salbutamol at the clinic visit for the next 10 days or:- 2) The same dose of each inhaler but in the opposite order Subjects will be assigned to groups randomly but will know which group they are in. The study will have up to 22 visits over 21 to 35 days including the screening period. There is a pre-screening visit to discuss medications subjects are taking. Subjects may be asked to stop taking certain medications used to treat COPD before starting the study. At Visit 1 (screening), subjects will have tests to find out if they are eligible for the study. Eligibility tests include ?½ Physical examination, medical history, smoking history, and use of alcohol and recreational drugs. ?½ Vital signs: weight, height, blood pressure, pulse ?½ pregnancy tests for women who can become pregnant ?½ Breathing tests- to measure the amount of air in the lungs and how fast it can be blown out. ?½ Lung volume measurements- tests inside body box equipment to accurately measure how much air the lungs can hold. ?½ Subject COPD questionnaires Eligible subjects will then attend the clinic daily and will have breathing tests at every visit.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0416

• Date of REC Opinion

  18 Jun 2012

• REC opinion

  Favourable Opinion