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

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ClinicalTrials.gov Identifier: NCT02233920
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
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

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
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


Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02233920     History of Changes
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:
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