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OpenTrials
Completed

NCT Number: NCT02232594

Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract 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

40 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 over 40 years with the symptoms of a chronic obstructive airways disease
  • Only patients which have not been treated with Berodual® within the last year should be included

Exclusion criteria

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

Treatment and study plan

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. Assessment of efficacy by investigator on a 4-point scale

    Time frame: after 3 and 6 weeks

  2. Assessment of efficacy by patient on a 4-point scale

    Time frame: after 3 and 6 weeks

  3. Assessment of tolerability by investigator on a 4-point scale

    Time frame: after 3 and 6 weeks

  4. Assessment of tolerability by patient on a 4-point scale

    Time frame: after 3 and 6 weeks

  5. Number of patients with adverse drug reactions

    Time frame: up to 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 Respiratory Tract Disease

Important dates

Study start
2000
Primary completion
2000
First posted
Sep 5, 2014
Registry last updated
Sep 5, 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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