Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Correctly Used the Device at the Start of Handling the Device
Study Overview
Brief Summary
This study compared the correct use of and patient preference for two drug delivery systems (inhalers) in patients with COPD
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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 (Drug)
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)