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Completed

NCT Number: NCT02182583

Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

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

Treatment and study plan

Ba253MDI

Drug

Other names: Tersigan® aerosol

Ba253BINEB

Drug

Primary outcomes

  1. Change in COPD daily symptom scores

    Time frame: Baseline and up to 4 weeks after first drug administration

Secondary outcomes

  1. Change from baseline in times of cough

    Time frame: Baseline, up to 4 weeks after first drug administration

  2. Change from baseline in peak expiratory flow rate (PEFR)

    Time frame: Baseline, up to 4 weeks after first drug administration

  3. Number of Patients with Adverse Events

    Time frame: Up to 4 weeks

  4. Number of patients with significant changes in vital sings (blood pressure, pulse rate)

    Time frame: Baseline, week 4

  5. Number of patients with abnormal changes in electrocardiogram (ECG)

    Time frame: Baseline, week 4

  6. Number of patients with abnormal changes in laboratory values

    Time frame: Baseline, week 4

  7. Physician's global evaluation

    Time frame: 4 weeks after first drug administration

  8. Patient's impression

    Time frame: 4 weeks after first drug administration

  9. Change from baseline in times and volume of sputum

    Time frame: Baseline, up to 4 weeks after first drug administration

  10. Change from baseline in transition of nocturnal sleep

    Time frame: Baseline, up to 4 weeks after first drug administration

  11. Change from baseline in FEV1 (Forced expiratory volume in one second)

    Time frame: Baseline, week 4

  12. Change from baseline in FVC (Forced vital capacity)

    Time frame: Baseline, week 4

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI

Important dates

Study start
1998
Primary completion
2000
First posted
Jul 8, 2014
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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