Patients of either sex, 40 years of age or older, and with a diagnosis of moderate to severe COPD MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: Tiotropium / Salmeterol 7.5/25 µg inhalation powder
Product Code: Ba 679 Br / BIIM 98 XI
Pharmaceutical Form: Inhalation powder, hard capsule
CAS Number: 411207313
Current Sponsor code:
Sponsors
Boehringer Ingelheim Pharma GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions. 2.) All patients must have a diagnosis of COPD and must meet the following criteria: relatively stable* airway obstruction with a post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.) Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or may influence either the results of the study or the patient’s ability to participate in the study. 2.) Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion 3.) Patients with a recent history (i.e., six months or less) of myocardial infarction. 4.) Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year. 5.) Hospitalisation for cardiac failure during the past year. 6.) Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 7.) Patients with a history of asthma or who have a total blood eosinophil count = 600/mm3. A repeat eosinophil count will not be conducted in these patients. 8.) Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis. 9.) Known active tuberculosis. 10.) Patients with a history (within the past two years) of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1. 11.) Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1. 12.) Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study. 13.) Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy. 14.) Patients who have taken an investigational drug within 30 days or six half-lives (whichever is greater) prior to Screening Visit (Visit 1). 15.) Use of antihistamines (H1 receptor antagonists), anti-leukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion No 7. 16.) Use of cromolyn sodium or nedocromil sodium. 17.) Use of systemic corticosteroid medication at unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 18.) Known hypersensitivity to anticholinergic drugs, ß2-adrenergic drugs, lactose or any other component of the study medication delivery systems. 19.) Pregnant or nursing women 20.) Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. 21.) Treatment with oral beta-adrenergics within 4 weeks prior to Screening Visit (Visit 1) or during the 2-week run-in period. 22
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to establish superiority of the once-daily Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in daytime lung function response (FEV1 AUC0-12, peak FEV1) and non-inferiority in night-time lung function response (FEV1 AUC12-24, trough FEV1) over the individual components inhaled in their established dose regimens when administered for 6-week periods.;Secondary Objective: The secondary objectives are to compare the safety of the Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder with the single marketed formulations administered as single drugs or as free combination in their established dose regimens. In addition, the 24-hour FEV1 profile of the free combination of Tiotropium (18 µg) Inhalation Powder in the morning plus Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening will be characterized and compared with the 24-hour profiles obtained with the other treatments.;Primary end point(s): The primary objective of this trial is to establish superiority of the once-daily Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in daytime lung function response (FEV1 AUC0-12, peak FEV1) and non-inferiority in night-time lung function response (FEV1 AUC12-24, trough FEV1) over the individual components inhaled in their established dose regimens when administered for 6-week periods. | — |
Countries
Germany
Outcome results
None listed