Chronic obstructive pulmonary disease (COPD).
Conditions
Interventions
Trade Name: SPIRIVA 18 microgram, inhalation powder, hard capsule
Pharmaceutical Form: Inhalation powder, hard capsule
Other descriptive name: Tiotropium
Concentration unit: µg microgram(s)
Concentrat
Sponsors
SCS Boehringer Ingelheim Comm.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients 40 years of age or older. Current or ex-smokers with a cigarette smoking history of = 10 pack years. A diagnosis of severe to very severe chronic obstructive pulmonary disease with post-bronchodilator FEV1 =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of thoracotomy with pulmonary resection. Current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy. Regular daytime oxygen therapy for more than 1 hour. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to or during screening. Myocardial infarction, unstable or life-threatening cardiac arrhythmia within three months prior to screening . Hospitalisation for cardiac failure in 12 months prior to initial screening. Malignancy requiring radiation or chemotherapy. Clinical diagnosis of bronchiectasis. Pregnant or nursing women or women of childbearing potential who are not using a medically approved means of contraception. Known hypersensitivity to study drugs. Current participation or recent completion of pulmonary rehabilitation program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to clarify the need for continuous inhaled corticosteroid use in patients with severe to very severe COPD (GOLD stage III to IV) on otherwise optimised therapy (according to guidelines) and to describe the effect of stepwise withdrawal of inhaled corticosteroids in these patients. ;Secondary Objective: An additional objective of this study is to characterise the patient population, potentially identifying sub-populations and markers of steroid need.;Primary end point(s): The primary endpoint for this study will be time to first moderate or severe on-treatment COPD exacerbation during the 12 month randomised period. | — |
Countries
Belgium, Bulgaria, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed