Randomized, double-blind, double-dummy, active-controlled, 4 period complete cross-over study to compare the effect on lung function of 6 weeks once daily treatment with orally inhaled tiotropium+olodaterol fixed dose combination delivered by the Respimat® inhaler vs. 6 weeks twice daily treatment with fluticasone propionate+salmeterol fixed dose combination delivered by the Accuhaler® in patients with Chronic Obstructive Pulmonary Disease (COPD) - ENERGITO

Boehringer Ingelheim0 sites66 target enrollmentStarted: TBDLast updated: April 29, 2024

Conditions

Trial Snapshot

No summary available.

•Written informed consent; Diagnosis of COPD; Male or female patients, 40 years of age or older; Smoking or non-smoker, smoking history of more than 10 pack years; Ability to perform requested procedures (spirometry, diary completion, inhalation of (study)medication.

•Significant disease other than COPD ; COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months before visit 1; Clinically relevant abnormal lab values; clinically relevant cardiovascular diseases; history of asthma; known active tuberculosis; pregnancy/breastfeeding; malignancies for which treatment is given in the past 5 years; history of life-threatening pulmonary obstruction; History of cystic fibrosis; Clinically evident bronchiectasis; History of significant alcohol or drug abuse; thoracotomy with pulmonary resection; oral or patch ß-adrenergics; Oral corticosteroid medication within 6 weeks prior to Visit 1; use daytime oxygen therapy for more than one hour per day; Pulmonary rehabilitation program in the six weeks prior to the screening visit; Investigational drug within one month or six half lives (whichever is greater) prior to screening visit ;Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA; Pregnant or nursing women

Sponsor