Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients

Study Overview
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Brief Summary
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This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD

Official Title
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Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Tiotropium
* Drug: Indacaterol


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure. Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD Guidelines 2010 or grade A in GOLD 2011and including: Smoking history of at least 10 pack years FEV1/FVC < 70% Key Exclusion criteria: Previous diagnosis of asthma Pregnant or nursing women Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol (QAB149) Breezhaler®<br>In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days. | Drug: Indacaterol<br>* Indacaterol via Breezhaler® device once a day<br>* Other names: Onbrize™;|
| Active Comparator: Tiotropium Respimat®<br>In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days. | Drug: Tiotropium<br>* Tiotropium via Respimat® device once a day<br>* Other names: Spiriva®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Correctly Used the Device at the Start of Handling the Device | The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Correctly Using the Device After One Week of Handling | The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices. | day 7 | 
| Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire | Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices. The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction | day 7 | 
| Number of Participants With Preference for Either Device | Participants answered a single question to determine their device preference. | day 7 | 
| Number of Participnats With Difficulties Experienced When Handling the Devices | Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breezhaler, Respimat, Indacaterol, Tiotropium