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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Indacaterol; Drug: Tiotropium

• Registration Number: NCT01727024
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-15
• Study Start: 2013-04
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2016-11-09
• Results First Submitted QC: 2016-11-09
• Status Verified: 2017-01
• Results First Posted: 2017-01-06
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure.

2. 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:

1. Previous diagnosis of asthma
2. Pregnant or nursing women
3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indacaterol (QAB149) Breezhaler®	Indacaterol	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.
Tiotropium Respimat®	Tiotropium	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Correctly Used the Device at the Start of Handling the Device	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 Outcome Measures

Name	Time	Method
Number of Participants With Preference for Either Device	day 7	Participants answered a single question to determine their device preference.
Number of Participnats With Difficulties Experienced When Handling the Devices	1 week	Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.
Number of Participants Correctly Using the Device After One Week of Handling	day 7	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.
Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire	day 7	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇧🇷 São Paulo, SP, Brazil