Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231359
• Other study ID #: 215.1363
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: September 2, 2014
• Start date: January 2004

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2006
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms

• Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included

Exclusion Criteria:

• Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Berodual® Respimat® solution for inhalation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in overall severity of clinical picture rated on 3-point scale		up to 12 weeks	No
Primary	Change in breathlessness rated on a 4-point scale		up to 12 weeks	No
Primary	Change in restriction of activity due to breathlessness rated on a 4-point scale		up to 12 weeks	No
Primary	Change in number of awakening due to nocturnal breathlessness rated on 4-point scale		up to 12 weeks	No
Primary	Global assessment of efficacy by the patients rated on 5-point scale		after 4, 8 and 12 weeks	No
Primary	Global assessment of efficacy by the investigator rated on 5-point scale		after 4, 8 and 12 weeks	No
Primary	Number of patients with adverse drug reactions		up to 12 weeks	No
Primary	Assessment of tolerability on a 5-point scale		after 4, 8 and 12 weeks	No

External Links

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