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Completed

NCT Number: NCT02182661

A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 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 bronchial asthma and who satisfy the following criteria

  • Patients aged >= 20 years or older
  • Patients with mild to moderate severity
  • Patients must be able to understand the patient information form

Exclusion criteria

  • Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the screening test
  • Patients using corticosteroid medication( p.o./ i.h.) at a dose in excess of the equivalent 10 mg/day of prednisolone
  • Patients with glaucoma
  • Patients who have prostatic hypertrophy
  • Patients with hypersensitivity to anticholinergic drugs
  • Patients who began treatment with hyposensitization or immunoregulator therapy within 3 month before the screening test
  • Patients complicated with chronic bronchitis, emphysema or bronchiectasis, making the assessment of drug efficacy against bronchial asthma difficult
  • 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

Ba253BINEB

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 30 weeks

  2. Number of patients with abnormal changes in blood pressure and heart rate

    Time frame: Baseline, up to 28 weeks

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

    Time frame: Baseline, up to 28 weeks

  4. Number of patients with abnormal changes in laboratory parameters

    Time frame: Baseline, up to 28 weeks

Secondary outcomes

  1. Change from baseline in symptom score

    Time frame: Baseline, up to 28 weeks

  2. Change from baseline in treatment score

    Time frame: Baseline, up to 28 weeks

  3. Change from baseline in asthma score

    Time frame: Baseline, week 28

  4. Change from baseline in daily life score

    Time frame: Baseline, up to 28 weeks

  5. Change from baseline in nocturnal sleep score

    Time frame: Baseline, up to 28 weeks

  6. Change from baseline in Peak expiratory flow rate (PEFR)

    Time frame: Baseline, up to 28 weeks

  7. Physician's global evaluation (overall improvement and final overall improvement)

    Time frame: Baseline, up to 28 weeks

  8. Patient's impression

    Time frame: Week 28

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

    Time frame: Baseline, up to 28 weeks

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

    Time frame: Baseline, up to 28 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase III Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

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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