Trial conducted to check Assessment of safety and efficacy for COPD patients. The patients will be on once daily treatment of tiotropium plus olodaterol fixed dose combination inhalation solution delivered by the Respimat® inhaler

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2012
INTERVENTION: Intervention1: Tiotropium+olodaterol 2.5 µg /5 µg combination: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks Intervention2: Tiotropium+olodaterol 5 µg /5 µg combination: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks Control Intervention1: Olodaterol 5 µg : Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks Control Intervention2: Tiotropium 2.5 µg: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks Control Intervention3: Tiotropium 5 µg: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks CONDITION: Chronic Obstructive Pulmonary Disorder PRIMARY OUTCOME: â?¢ FEV1 AUC0‐3h response ; â?¢ Trough FEV1 response ; â?¢ SGRQ (total score) (Combined data from 1237.5 and1237.6) ; ‐‐‐‐‐‐Timepoint: 24 weeks SECONDARY OUTCOME: The TDI focal score (to measure the effect of tiotropium plus olodaterol combination on patientsâ?? health‐related quality of life) is key secondary endpoint (Combined data from 1237.5 and1237.6) ; ‐‐‐‐‐‐Timepoint: 24 weeks INCLUSION CRITERIA: 1. All patients must sign an informed consent consistent with ICH‐GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of COPD [P10‐01267] and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post‐bronchodilator FEV1 < 80% of predicted normal (ECSC, [R94‐1408]; GOLD II ‐ IV, [P10‐01267] and a post‐bronchodilator FEV1/FVC <70% at Visit 1 (See Appendix 10.3 for ECSC predicted normal equations). 3. Male or female patients, 40 years of age or older. 4. Patients must be current or ex‐smokers with a smoking history of more than 10 pack years. (see Appendix 10.3 for calculation): Patients who have never smoked cigarettes must be excluded. 5. Patients must be able to â?¢ perform technically acceptab
Epistemonikos ID: 1dcf10a4d934c8672eefaf31791b7faaa8fdfa03
First added on: Aug 22, 2024