Status:
COMPLETED
Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
COPD
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices with t...
Detailed Description
Salbutamol (VentolinTM) is a short acting beta agonist (SABA) which is used to treat wheezing, dyspnea and breathing difficulties caused by asthma and COPD. Further, it is also used to prevent broncho...
Eligibility Criteria
Inclusion
- Patients with documented COPD based on the following criteria:
- Smoking history of at least 10 pack-years.
- Decreased Tiffeneau index (FEV1/(F)VC \< 0.70).
- Patients aged ≥ 40 years.
- Patients should present moderate to severe COPD with an FEV1 between 30 and 80% of predicted (GOLD 2 and 3).
- Patients should be treated according to GOLD guidelines.
- Able to inhale study drug.
- Maintained on stable respiratory medications for 6 weeks prior to visit 1.
- Able to perform lung function tests.
- Able to follow study procedures.
Exclusion
- Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product.
- Patients allergic to sojalecithin and products on the basis of soja and peanut.
- Patients who have or ever had glaucoma.
- Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
- Patients with a recent history (i.e. six months or less) of myocardial infarction.
- Patients with any unstable or life threatening cardiac arrhythmia.
- Patients with severe kidney insufficiency (creatinine clearance ≤50 ml/min)a.
- Patients below the age of 40.
- Patients who are pregnant or are breast-feeding.
- Patients who are treated with other anticholinergic medications, that cannot be stopped during the study period.
- A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
- Significant alcohol or drug abuse within the past 12 months.
- Participation in another trial with an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
- Known active tuberculosis.
- A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
- A history of thoracotomy with pulmonary resection.
- Active or untreated malignancy.
- Use of oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses ≥ 10 mg/day.
- a Cockroft's formulae should be applied: in male: creatinine clearance = (140-age) x weight / 72 x creatininemia in female: creatinine clearance = 0.85 x (140-age) x weight / 72 x creatininemia
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00911651
Start Date
June 1 2008
End Date
August 1 2008
Last Update
June 2 2009
Active Locations (1)
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1
Antwerp University Hospital
Antwerp, Antwerp, Belgium, 2650