A randomised, double-blind, active-controlled study to evaluate the impact of stepwise withdrawal of inhaled corticosteroid treatment in patients with severe to very severe chronic obstructive pulmonary disease (COPD) on optimised bronchodilator therapy.

Boehringer Ingelheim Limited0 sites2,400 target enrollmentStarted: December 16, 2008Last updated: November 25, 2019

Conditions

Drugs

Trial Snapshot

No summary available.

•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 <50% of predicted and FEV1 < 70% of FVC.
•At least one documented* exacerbation during the 12-month period prior to initial screening.
•Able to perform all study related procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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.

Sponsor