- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02231372
Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
September 2, 2014 updated by: Boehringer Ingelheim
Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4602
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with diagonsis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology
Description
Inclusion Criteria:
- Men and women presenting with symptoms of chronic obstructive pulmonary disease
- Both previously untreated patients and patients treated previously with Berodual® or with other anti-obstructive respiratory tract agents may be included
Exclusion Criteria:
- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
chronic obstructive airways disease patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse drug reactions
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Change in overall severity rated on 3-point scale
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Change in reduction in breathlessness rated on a 4-point scale
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Change in restriction of activity due to breathlessness rated on a 4-point scale
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Number of awakening due to nocturnal breathlessness rated on 4-point scale
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Global assessment of efficacy by the patients rated on 5-point scale
Time Frame: after 4 weeks
|
after 4 weeks
|
Global assessment of efficacy by the investigator rated on 5-point scale
Time Frame: after 4 weeks
|
after 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
September 2, 2014
First Submitted That Met QC Criteria
September 2, 2014
First Posted (Estimate)
September 4, 2014
Study Record Updates
Last Update Posted (Estimate)
September 4, 2014
Last Update Submitted That Met QC Criteria
September 2, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 215.1362
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Disease, Chronic Obstructive
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Mylan Inc.Theravance BiopharmaCompletedChronic Obstructive Pulmonary Disease (COPD)United States
-
University Hospital, GhentGlaxoSmithKline; University GhentCompletedChronic Obstructive Pulmonary Disease (COPD)Belgium
-
Optimum Patient CareRespiratory Effectiveness Group; Boehringer Ingelheim Pharmaceutical Company... and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (13645005)United States
-
Poitiers University HospitalCompletedBroncho Chronic Obstructive Pulmonary DiseaseFrance
Clinical Trials on Berodual® Respimat® solution for inhalation
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic Obstructive
-
Boehringer IngelheimTerminatedPulmonary Disease, Chronic Obstructive
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveGermany
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveItaly
-
Glenmark Specialty S.A.CompletedMild to Moderate Chronic Obstructive Pulmonary Disease (COPD)United States