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Post-marketing Surveillance of Ventilat® Metered Dose Inhaler in Chronic Obstructive Bronchitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02233920
First Posted: September 9, 2014
Last Update Posted: September 9, 2014
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of daily practice

Condition Intervention
Pulmonary Disease, Chronic Obstructive Drug: Ventilat® - metered dose inhaler

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postmarketing Surveillance Study (as Per § 67(6) AMG [German Drug Law]) of Ventilat® Metered-dose Inhaler in Chronic Obstructive Bronchitis

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in the clinical picture [ Time Frame: after 4 weeks ]

Secondary Outcome Measures:
  • Assessment of efficacy by investigator on a 4-point scale [ Time Frame: after 4 weeks ]
  • Assessment of efficacy by patient on a 4-point scale [ Time Frame: after 4 weeks ]
  • Number of patients with adverse drug reactions [ Time Frame: up to 4 weeks ]
  • Assessment of tolerability by investigator on a 4-point scale [ Time Frame: after 4 weeks ]
  • Assessment of patient by investigator on a 4-point scale [ Time Frame: after 4 weeks ]

Enrollment: 716
Study Start Date: January 2000
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic obstructive bronchitis patients Drug: Ventilat® - metered dose inhaler

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

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

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02233920     History of Changes
Other Study ID Numbers: 54.564
First Submitted: September 8, 2014
First Posted: September 9, 2014
Last Update Posted: September 9, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections
Oxitropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs