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OpenTrials
Completed

NCT Number: NCT02238132

Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Airways Disease

To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways Disease under conditions of 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

Age range

18 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

  • Primarily, Patients with chronic obstructive airways disease
  • Only patients who had not been treated with Atrovent® in the last year were to be considered for inclusion

Exclusion criteria

  • Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® inhalets

Treatment and study plan

Atrovent® inhalets

Drug

Primary outcomes

  1. Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile

    Time frame: Up to 4 weeks after first study drug administration

Secondary outcomes

  1. Investigator assessment of efficacy on a 4-point scale

    Time frame: Up to 4 weeks after first study drug administration

  2. Investigator assessment of tolerability on a 4-point scale

    Time frame: Up to 4 weeks after first study drug administration

  3. Number of patients with adverse drug reactions

    Time frame: Up to 4 weeks after first study drug administration

  4. Number of patients who withdrew from the study

    Time frame: Up to 4 weeks after first study drug administration

  5. Number of patients who changed the concomitant medication

    Time frame: Up to 4 weeks after first study drug administration

  6. Number of patients who continued the treatment

    Time frame: Up to 4 weeks after first study drug administration

  7. Patient assessment of efficacy on a 4-point scale

    Time frame: Up to 4 weeks after first study drug administration

  8. Patient assessment of tolerability on a 4-point scale

    Time frame: Up to 4 weeks after first study drug administration

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 Atrovent® Inhalets in Chronic Obstructive Airways Disease

Important dates

Study start
1998
Primary completion
1999
First posted
Sep 12, 2014
Registry last updated
Sep 12, 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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