Skip to main content
OpenTrials
Completed

NCT Number: NCT02231346

Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Comparison to a Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease

New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients aged at least 18 years
  • Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices
  • During the PMS the Diskus® therapy is to be continued

Exclusion criteria

  • Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

Treatment and study plan

Berodual® Respimat® - inhaler

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: up to 4 weeks

  2. Number of patients who prematurely discontinued therapy with Berodual® Respimat®

    Time frame: up to 4 weeks

Secondary outcomes

  1. Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler

    Time frame: up to 4 weeks

    by means of a patient satisfaction and preference questionnaire (PASAPQ)

  2. Assessment of patient satisfaction with regard to handling of Diskus® inhaler

    Time frame: Baseline

    by means of patient satisfaction and preference questionnaire (PASAPQ)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction in Comparison to a Powder Inhaler

Important dates

Study start
2005
Primary completion
2006
First posted
Sep 4, 2014
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.