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OpenTrials
Completed

NCT Number: NCT02236715

Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose vial 500 µg 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

30 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 of both gender, older than 30 years, who suffer from chronic obstructive airways disease
  • Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion criteria

  • Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® unit dose vial 500 µg

Treatment and study plan

Atrovent®

Drug

Primary outcomes

  1. Change in total severity of the clinical picture rated on a 4-point scale

    Time frame: after 4 weeks

Secondary outcomes

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

    Time frame: after 4 weeks

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

    Time frame: after 4 weeks

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

    Time frame: after 4 weeks

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

    Time frame: after 4 weeks

  5. Number of patients with adverse drug reactions

    Time frame: up to 4 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 Atrovent® Unit Dose Vial 500 µg in Chronic Obstructive Airways Disease

Important dates

Study start
1999
Primary completion
2000
First posted
Sep 11, 2014
Registry last updated
Sep 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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