Completed
Cross-sectional Study to Assess the Handling , Patient Satisfaction, and Preference for Inhalation Devices in Patients With Chronic Obstructive Pulmonary Disease (COPD).
What is being collected
Device Data
+ device Data
Collected at a single point in time - Cross-sectionalDevice
Who is being recruted
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Over 18 Years
+5 Eligibility Criteria
How is the trial designed
Observational
Study Start: March 2013
Summary
Principal SponsorBoehringer Ingelheim
Last updated: March 26, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.Purpose: Study Design:
Principal SponsorBoehringer Ingelheim
Last updated: March 26, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive
Criteria
2 inclusion criteria required to participate
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
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
3 exclusion criteria prevent from participating
Patients who are treated simultaneously with both respiratory medications (Spiriva Respimat and Hirobriz Breezhaler / Onbrez Breezhaler / Oslif Breezhaler)
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Boehringer Ingelheim Investigational Site 13
A Coruña, SpainOpen Boehringer Ingelheim Investigational Site 13 in Google MapsBoehringer Ingelheim Investigational Site 5
Barcelona, SpainBoehringer Ingelheim Investigational Site 6
Barcelona, SpainBoehringer Ingelheim Investigational Site 8
Barcelona, SpainCompleted15 Study Centers