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Completed

NCT Number: NCT02231424

Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

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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

6 year and older

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

  • Patients of either sex, including children over 6 years
  • Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)

Exclusion criteria

  • Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler

Treatment and study plan

Drug: Berodual®

Drug

Primary outcomes

  1. Overall severity of the clinical picture rated on a 4-point scale

    Time frame: after 3 and 6 weeks

Secondary outcomes

  1. Changes in dyspnea and/or asthma attacks rated on a 4-point scale

    Time frame: after 3 and 6 weeks

  2. Number of dyspnea episodes rated on a 4-point scale

    Time frame: after 3 and 6 weeks

  3. Number of awakenings due to night-time dyspnea rated on a 4-point scale

    Time frame: after 3 and 6 weeks

  4. Assessment of morning coughing with expectoration rated on a 4-point scale

    Time frame: after 3 and 6 weeks

  5. Assessment of tolerability on a 4-point scale

    Time frame: after 3 and 6 weeks

  6. Number of patients with adverse drug reactions

    Time frame: up to 6 weeks

  7. Changes in pathological auscultation findings rated on a 3-point scale

    Time frame: after 3 and 6 weeks

  8. Changes in concomitant medication

    Time frame: up to 6 weeks

  9. Assessment of efficacy on a 4-point scale

    Time frame: after 3 and 6 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

Important dates

Study start
1999
Primary completion
1999
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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