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Trial record 18 of 150 for:    Ipratropium OR atrovent

Post-marketing Surveillance of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02233894
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Atrovent® - inhalets

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Study Type : Observational
Actual Enrollment : 526 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
Study Start Date : February 2001
Actual Primary Completion Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Chronic obstructive pulmonary disease patients Drug: Atrovent® - inhalets

Primary Outcome Measures :
  1. Change in overall severity of the clinical picture [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Assessment of efficacy by investigator on a 4-point scale [ Time Frame: after 3 months ]
  2. Assessment of efficacy by patient on a 4-point scale [ Time Frame: after 3 months ]
  3. Number of patients with adverse drug reactions [ Time Frame: 3 months ]
  4. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: after 3 months ]
  5. Assessment of tolerability by patient on a 4-point scale [ Time Frame: after 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with chronic obstructive pulmonary disease recruited at general practitioners

Inclusion Criteria:

  • Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
  • Only patients who have not been treated with Atrovent® within the last year are to be considered for inclusion

Exclusion Criteria:

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

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02233894     History of Changes
Other Study ID Numbers: 244.2502
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action