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

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: NCT02233920
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 Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of daily practice

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Ventilat® - metered dose inhaler

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Study Type : Observational
Actual Enrollment : 716 participants
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
Study Start Date : January 2000
Actual Primary Completion Date : December 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Group/Cohort Intervention/treatment
Chronic obstructive bronchitis patients Drug: Ventilat® - metered dose inhaler

Primary Outcome Measures :
  1. Change in the clinical picture [ 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. Number of patients with adverse drug reactions [ Time Frame: up to 4 weeks ]
  4. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: after 4 weeks ]
  5. Assessment of patient by investigator on a 4-point scale [ Time Frame: after 4 weeks ]

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 bronchitis disease recruited at pneumologists

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

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02233920    
Other Study ID Numbers: 54.564
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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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs