Preference Tiotropium Respimat Study in COPD

NCT01810692 | Completed Results

• 1 other identifier: 205.514
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 15

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)

  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.

  day 1

Secondary Outcomes (3)

• Total Performance PASAPQ Score.

  day 1

• Total Convenience PASAPQ Score

  day 1

• Overall Satisfaction Question

  day 1

Study Arms (2)

Group 1

Device: Group1:Spiriva® Respimat®

Group 2

Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®

Interventions

Group1:Spiriva® Respimat® DEVICE

COPD patients using Respimat®

Group 1

Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler® DEVICE

COPD patients using Breezhaler®®

Group 2

Eligibility Criteria

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

Study Population

COPD

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (15)

Boehringer Ingelheim Investigational Site 13

A Coruña, Spain

Location

Boehringer Ingelheim Investigational Site 5

Barcelona, Spain

Location

Boehringer Ingelheim Investigational Site 6

Barcelona, Spain

Location

Boehringer Ingelheim Investigational Site 8

Barcelona, Spain

Location

Boehringer Ingelheim Investigational Site 12

Burgos, Spain

Location

Boehringer Ingelheim Investigational Site 14

Galdako., Spain

Location

Boehringer Ingelheim Investigational Site 11

Laredo, Spain

Location

Boehringer Ingelheim Investigational Site 1

Málaga, Spain

Location

Boehringer Ingelheim Investigational Site 3

Mérida, Spain

Location

Boehringer Ingelheim Investigational Site 15

Palma de Mallorca, Spain

Location

Boehringer Ingelheim Investigational Site 9

Pozuelo de Alarcón, Spain

Location

Boehringer Ingelheim Investigational Site 7

Sabadell, Spain

Location

Boehringer Ingelheim Investigational Site 2

Seville, Spain

Location

Boehringer Ingelheim Investigational Site 10

Torrelodones, Spain

Location

Boehringer Ingelheim Investigational Site 4

Villanueva de la Serena, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 26, 2015
• Results First Posted: March 26, 2015

Record last verified: 2015-03

Locations

ES (15)