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Trial record 8 of 151 for:    Ipratropium OR atrovent

Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

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ClinicalTrials.gov Identifier: NCT02236715
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

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

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Study Type : Observational
Actual Enrollment : 1039 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Unit Dose Vial 500 µg in Chronic Obstructive Airways Disease
Study Start Date : September 1999
Actual Primary Completion Date : February 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Group/Cohort Intervention/treatment
Chronic Obstructive Airways Disease Drug: Atrovent®



Primary Outcome Measures :
  1. Change in total severity of the clinical picture rated on a 4-point scale [ Time Frame: after 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02236715     History of Changes
Other Study ID Numbers: 244.2493
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Ipratropium
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
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