NCT02231372

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,602

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
Last Updated

September 4, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

September 2, 2014

Last Update Submit

September 2, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (7)

  • Change in overall severity rated on 3-point scale

    up to 4 weeks

  • Change in reduction in breathlessness rated on a 4-point scale

    up to 4 weeks

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

    up to 4 weeks

  • Number of awakening due to nocturnal breathlessness rated on 4-point scale

    up to 4 weeks

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

    after 4 weeks

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

    after 4 weeks

  • Number of patients with adverse drug reactions

    up to 4 weeks

Study Arms (1)

chronic obstructive airways disease patients

Drug: Berodual® Respimat® solution for inhalation

Interventions

Berodual® Respimat® solution for inhalationDRUG
chronic obstructive airways disease patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory 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

March 1, 2004

Primary Completion

December 1, 2004

Last Updated

September 4, 2014

Record last verified: 2014-09