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

NCT02231359 | Completed

• 1 other identifier: 215.1363
• Study Type: observational
• Target: 2,006
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (8)

• Change in overall severity of clinical picture rated on 3-point scale

  up to 12 weeks

• Change in breathlessness rated on a 4-point scale

  up to 12 weeks

• Change in restriction of activity due to breathlessness rated on a 4-point scale

  up to 12 weeks

• Change in number of awakening due to nocturnal breathlessness rated on 4-point scale

  up to 12 weeks

• Global assessment of efficacy by the patients rated on 5-point scale

  after 4, 8 and 12 weeks

• Global assessment of efficacy by the investigator rated on 5-point scale

  after 4, 8 and 12 weeks

• Number of patients with adverse drug reactions

  up to 12 weeks

• Assessment of tolerability on a 5-point scale

  after 4, 8 and 12 weeks

Study Arms (1)

chronic obstructive airways disease patients

Drug: Berodual® Respimat® solution for inhalation

Interventions

Berodual® Respimat® solution for inhalation DRUG

chronic obstructive airways disease patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology in practice

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: January 1, 2004
• Primary Completion: September 1, 2004
• Last Updated: September 4, 2014

Record last verified: 2014-09