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OpenTrials
Completed

NCT Number: NCT02231359

Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice

Completed

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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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms
  • Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included

Exclusion criteria

  • Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Treatment and study plan

Berodual® Respimat® solution for inhalation

Drug

Primary outcomes

  1. Change in overall severity of clinical picture rated on 3-point scale

    Time frame: up to 12 weeks

  2. Change in breathlessness rated on a 4-point scale

    Time frame: up to 12 weeks

  3. Change in restriction of activity due to breathlessness rated on a 4-point scale

    Time frame: up to 12 weeks

  4. Change in number of awakening due to nocturnal breathlessness rated on 4-point scale

    Time frame: up to 12 weeks

  5. Global assessment of efficacy by the patients rated on 5-point scale

    Time frame: after 4, 8 and 12 weeks

  6. Global assessment of efficacy by the investigator rated on 5-point scale

    Time frame: after 4, 8 and 12 weeks

  7. Number of patients with adverse drug reactions

    Time frame: up to 12 weeks

  8. Assessment of tolerability on a 5-point scale

    Time frame: after 4, 8 and 12 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Important dates

Study start
2004
Primary completion
2004
First posted
Sep 4, 2014
Registry last updated
Sep 4, 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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