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

Novartis Pharmaceuticals140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

TiotropiumDRUG

Tiotropium via Respimat® device once a day

IndacaterolDRUG

Indacaterol via Breezhaler® device once a day

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Key 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

Locations (10)

Novartis Investigative Site

Goiânia, Goiás, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Outcomes

Primary Outcomes

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.

Time frame: day 1

Secondary Outcomes

Number of Participants Correctly Using the Device After One Week of Handling

Time frame: 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

Time frame: day 7

Number of Participants With Preference for Either Device

Participants answered a single question to determine their device preference.

Time frame: 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.

Time frame: 1 week

Data from ClinicalTrials.gov

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