NCT02242253
Completed
Phase 2
A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of the Free Combinations of Tiotropium Inhalation Powder Capsule (18 μg) QD + Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) QD or BID, Tiotropium Inhalation Powder Capsule (18 μg) QD and Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) BID in Patients With (COPD)
ConditionsPulmonary Disease, Chronic Obstructive
Overview
- Phase
- Phase 2
- Intervention
- Tiotropium
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 97
- Primary Endpoint
- Area under the curve of forced expiratory volume in one second (FEV1 AUC0-24h)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Main Study: To evaluate and to compare the lung function response to the free combinations of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18 μg QD at the end of 6-week treatment periods in patients with COPD.
Sub-Study: Was performed in subset of patients participating in the Main Study to assess the effect of the four randomised treatments on dynamic hyperinflation.
Extension Study: To establish whether the FEV1 time profile following combination bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical formulation of salmeterol, i.e. the MDI or the Diskus®.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions
- •All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- •Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visits 1 and 2)
- •Male or female patients 40 years of age or older
- •Patients must be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes have to be excluded)
- •Patients must be able to perform technically acceptable pulmonary function tests and must be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol
- •Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)
Exclusion Criteria
- •Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- •Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1
- •Patients with a recent history (i.e. six months or less) of myocardial infarction
- •Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalised for such an event within the past year
- •Patients with a 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
- •Patients with known narrow-angle glaucoma
- •Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm3
- •Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
- •Patients with known active tuberculosis
- •Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1
Arms & Interventions
Tiotropium+salmeterol QD
free combination of tiotropium and salmeterol
Intervention: Tiotropium
Tiotropium+salmeterol QD
free combination of tiotropium and salmeterol
Intervention: Salmeterol
Tiotropium+salmeterol QD
free combination of tiotropium and salmeterol
Intervention: Placebo-MDI
Tiotropium+salmeterol BID
free combination of tiotropium and salmeterol
Intervention: Tiotropium
Tiotropium+salmeterol BID
free combination of tiotropium and salmeterol
Intervention: Salmeterol
Tiotropium+salmeterol BID
free combination of tiotropium and salmeterol
Intervention: Placebo-MDI
Tiotropium QD
Intervention: Tiotropium
Tiotropium QD
Intervention: Placebo-MDI
Salmeterol BID
Intervention: Salmeterol
Salmeterol BID
Intervention: Placebo HandiHaler®
Outcomes
Primary Outcomes
Area under the curve of forced expiratory volume in one second (FEV1 AUC0-24h)
Time Frame: up to 12 hours after morning and evening dose
FEV1 AUC0-12h
Time Frame: up to 12 hours after morning and evening dose
Secondary Outcomes
- FEV1 AUC12-24h(after 6 weeks of each treatment)
- AUC of forced vital capacity (FVC AUC0-12h)(after 6 weeks of each treatment)
- FVC AUC0-24h(after 6 weeks of each treatment)
- FVC AUC12-24h(after 6 weeks of each treatment)
- Peak FEV1(after 6 weeks of each treatment)
- Trough FEV1(after 6 weeks of each treatment)
- Peak FVC(after 6 weeks of each treatment)
- Trough FVC(after 6 weeks of each treatment)
- Individual FEV measurements at each time point(up to 6 weeks)
- Individual FVC measurements at each time point(up to 6 weeks)
- Peak expiratory flow rate (PEFR) measured twice daily(weeks 4 to 6 of each treatment period)
- Number of inhalations of rescue salbutamol therapy used per day(weeks 4 to 6 of each treatment period)
- Change in focal score of the Mahler Transition Dyspnea Index (TDI)(after 6 weeks of each treatment)
- Number of patients with adverse events(up to 33 weeks)
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