Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 4
- Intervention
- Indacaterol
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Correctly Used the Device at the Start of Handling the Device
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Indacaterol (QAB149) Breezhaler®
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.
Intervention: Indacaterol
Tiotropium Respimat®
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.
Intervention: Tiotropium
Outcomes
Primary Outcomes
Number of Participants Who Correctly Used the Device at the Start of Handling the Device
Time Frame: day 1
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.
Secondary Outcomes
- Number of Participants With Preference for Either Device(day 7)
- Number of Participnats With Difficulties Experienced When Handling the Devices(1 week)
- Number of Participants Correctly Using the Device After One Week of Handling(day 7)
- Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire(day 7)