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OpenTrials
Completed

NCT Number: NCT02238197

Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease

To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary 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

13 year–89 year

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 both genders, older than 40 years,who suffer from chronic obstructive Pulmonary 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® 500µg/2ml Inhalation Solution
  • Patients who exhibited adverse drug reactions

Treatment and study plan

Atrovent® Inhalation Solution

Drug

Primary outcomes

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

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

  2. Investigator assessment of improvement of 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. Assessment of efficacy by investigator on a 4-point scale

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

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

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

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

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

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

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

  5. Number of patients with adverse drug reactions

    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® 500µg/2ml Inhalation Solution in Chronic Obstructive Pulmonary Disease

Important dates

Study start
2001
Primary completion
2001
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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