Pulmonary Disease, Chronic ObstructiveNCT01810692

Preference Tiotropium Respimat Study in COPD

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 15 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Group1:Spiriva® Respimat® and Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®
Type of treatment: Medical device
How many people: 150 participants
Where: 15 sitesSpain
Study dates: Mar 2013to Mar 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: COPD

Who may be able to join

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.

Who cannot join

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®).

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Spain15 sites

Boehringer Ingelheim Investigational Site 13
A Coruña
Boehringer Ingelheim Investigational Site 5
Barcelona
Boehringer Ingelheim Investigational Site 6
Barcelona
Boehringer Ingelheim Investigational Site 8
Barcelona
Boehringer Ingelheim Investigational Site 12
Burgos
Boehringer Ingelheim Investigational Site 14
Galdako.
Boehringer Ingelheim Investigational Site 11
Laredo
Boehringer Ingelheim Investigational Site 1
Málaga
Boehringer Ingelheim Investigational Site 3
Mérida
Boehringer Ingelheim Investigational Site 15
Palma de Mallorca
Boehringer Ingelheim Investigational Site 9
Pozuelo de Alarcón
Boehringer Ingelheim Investigational Site 7
Sabadell
Boehringer Ingelheim Investigational Site 2
Seville
Boehringer Ingelheim Investigational Site 10
Torrelodones
Boehringer Ingelheim Investigational Site 4
Villanueva de la Serena

Other trials in Spain

About this study

Official title: Cross-sectional Study to Assess the Handling , Patient Satisfaction, and Preference for Inhalation Devices in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Read the detailed description

Purpose:

Study Design:

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Group1:Spiriva® Respimat®, Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group1:Spiriva® Respimat®Device
COPD patients using Respimat®
Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®Device
COPD patients using Breezhaler®®

Study groups in NCT01810692
Study group	Role	What they receive
Group 1		Not described Receives: Device: Group1:Spiriva® Respimat®
Group 2		Not described Receives: Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: day 1

Secondary outcomes (3)

Total Performance PASAPQ Score.
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.
Measured: day 1
Total Convenience PASAPQ Score
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.
Measured: day 1
Overall Satisfaction Question
The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.
Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Mar 2014

First posted13 Mar 2013 (estimated)
Study startMar 2013
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Cross-sectional
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01810692
Sponsor's protocol ID: 205.514
Status last verified: Mar 2015
First submitted: 12 Mar 2013
Last updated: 26 Mar 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cross-sectional Study to Assess the Handling , Patient Satisfaction, and Preference for Inhalation Devices in Patients With Chronic Obstructive Pulmonary Disease (COPD).
ClinicalTrials.gov ID: NCT01810692
Acronym / sponsor ID: 205.514
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 13 Mar 2013 (estimated)
Results: Posted 26 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Purpose:

Study Design:

Study design

Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Group 1	–	Device: Group1:Spiriva® Respimat®
Group 2	–	Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: COPD

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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®).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group1:Spiriva® Respimat®COPD patients using Respimat®	Device	Group 1
Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®COPD patients using Breezhaler®®	Device	Group 2

Primary outcome

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.

3 secondary outcomes

Total Performance PASAPQ Score.
Time frame: day 1
Total Convenience PASAPQ Score
Time frame: day 1
Overall Satisfaction Question
Time frame: day 1

Results and safety

Results posted to the registry on 26 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spiriva Respimat	77	77
Hirobriz/Onbrez/Oslif Breezhaler	77	77

Primary outcome: Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)

Time frame: day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Spiriva Respimat n = 77	Hirobriz/Onbrez/Oslif Breezhaler n = 77
Value	80.71 (10.47)	79.92 (12.68)

Population analysed: Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiriva Respimat	0 of 77 (0%)	0 of 77 (0%)	Not reported
Hirobriz/Onbrez/Oslif Breezhaler	0 of 77 (0%)	0 of 77 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 15 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01810692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.