Clinical trial NCT02182583: Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 163
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.


Eligibility criteria: Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

1. Patients whose symptoms are stable and have at least 4 symptomatic days a week
2. Patients with FEV1.0/FVC of \<= 70% in the screening test
3. Patients aged \>= 40 years or older
4. Patients must be able to inhale the study drug via BINEB and MDI
5. Patients must be able to understand the patient information form

Exclusion Criteria:

Those who correspond to the following shall be excluded from the subjects of study.

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients who are constantly administered oral steroid
3. Patients with glaucoma
4. Patients who have prostatic hypertrophy
5. Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
6. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
7. Women who are pregnant or who may become pregnant, or nursing women
8. Patients who are judged by the investigator as inappropriate as the subjects of the study

Primary outcomes:
measure: Change in COPD daily symptom scores
timeFrame: Baseline and up to 4 weeks after first drug administration
Secondary outcomes:
measure: Change from baseline in times of cough
timeFrame: Baseline, up to 4 weeks after first drug administration
measure: Change from baseline in peak expiratory flow rate (PEFR)
timeFrame: Baseline, up to 4 weeks after first drug administration
measure: Number of Patients with Adverse Events
timeFrame: Up to 4 weeks
measure: Number of patients with significant changes in vital sings (blood pressure, pulse rate)
timeFrame: Baseline, week 4
measure: Number of patients with abnormal changes in electrocardiogram (ECG)
timeFrame: Baseline, week 4
measure: Number of patients with abnormal changes in laboratory values
timeFrame: Baseline, week 4
measure: Physician's global evaluation
timeFrame: 4 weeks after first drug administration
measure: Patient's impression
timeFrame: 4 weeks after first drug administration
measure: Change from baseline in times and volume of sputum
timeFrame: Baseline, up to 4 weeks after first drug administration
measure: Change from baseline in transition of nocturnal sleep
timeFrame: Baseline, up to 4 weeks after first drug administration
measure: Change from baseline in FEV1 (Forced expiratory volume in one second)
timeFrame: Baseline, week 4
measure: Change from baseline in FVC (Forced vital capacity)
timeFrame: Baseline, week 4
Other outcomes:
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