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Preference Tiotropium Respimat Study in COPD

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ClinicalTrials.gov Identifier: NCT01810692
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : March 26, 2015
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
In COPD the patient's ability to use inhalers correctly and their preference for the inhaler are both important factors in selecting an appropriate treatment for COPD. This is a cross-sectional study where satisfaction, preference and handling of two different devices such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD patients

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Device: Group1:Spiriva® Respimat® Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®

Detailed Description:

Purpose:

Study Design:


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Study Type : Observational
Actual Enrollment : 150 participants
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Study to Assess the Handling , Patient Satisfaction, and Preference for Inhalation Devices in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Group 1 Device: Group1:Spiriva® Respimat®
COPD patients using Respimat®

Group 2 Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®
COPD patients using Breezhaler®®




Primary Outcome Measures :
  1. Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) [ Time Frame: day 1 ]
    Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.


Secondary Outcome Measures :
  1. Total Performance PASAPQ Score. [ Time Frame: day 1 ]
    All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.

  2. Total Convenience PASAPQ Score [ Time Frame: day 1 ]
    All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.

  3. Overall Satisfaction Question [ Time Frame: day 1 ]
    The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
COPD
Criteria

Inclusion criteria:

  1. All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the study and conducting any study procedures.
  2. Adult male or female patients with chronic obstructive pulmonary disease (COPD) for less than a year who follow usual clinical practice of the participant sites and who are on treatment with Spiriva® Respimat®, Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler® for at least of 3 months but not more than maximum of 6 months before the informed consent date.

Exclusion criteria:

  1. Previously included in this study or currently participating in another interventional study.
  2. Visual, cognitive, or motor impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaire.
  3. Patients who are treated simultaneously with both respiratory medications (Spiriva® Respimat® and Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler®).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810692


Locations
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Spain
Boehringer Ingelheim Investigational Site 13
A Coruña, Spain
Boehringer Ingelheim Investigational Site 5
Barcelona, Spain
Boehringer Ingelheim Investigational Site 6
Barcelona, Spain
Boehringer Ingelheim Investigational Site 8
Barcelona, Spain
Boehringer Ingelheim Investigational Site 12
Burgos, Spain
Boehringer Ingelheim Investigational Site 14
Galdako., Spain
Boehringer Ingelheim Investigational Site 11
Laredo, Spain
Boehringer Ingelheim Investigational Site 1
Málaga, Spain
Boehringer Ingelheim Investigational Site 3
Mérida, Spain
Boehringer Ingelheim Investigational Site 15
Palma de Mallorca., Spain
Boehringer Ingelheim Investigational Site 9
Pozuelo de Alarcón, Spain
Boehringer Ingelheim Investigational Site 7
Sabadell, Spain
Boehringer Ingelheim Investigational Site 2
Sevilla, Spain
Boehringer Ingelheim Investigational Site 10
Torrelodones, Spain
Boehringer Ingelheim Investigational Site 4
Villanueva de la Serena, Spain
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01810692     History of Changes
Other Study ID Numbers: 205.514
First Posted: March 13, 2013    Key Record Dates
Results First Posted: March 26, 2015
Last Update Posted: March 26, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action