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

January 23, 2017 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • GO
      • Goiania, GO, Brazil, 74110-030
        • Novartis Investigative Site
    • MG
      • Belo Horizonte, MG, Brazil, 30130-100
        • Novartis Investigative Site
      • Belo Horizonte, MG, Brazil, 30150-281
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20551-030
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Novartis Investigative Site
      • Porto Alegre, RS, Brazil, 90610-000
        • Novartis Investigative Site
    • SC
      • Florianopolis, SC, Brazil, 88040-970
        • Novartis Investigative Site
    • SP
      • Ribeirao Preto, SP, Brazil, 14048-900
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazil, 04039-004
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 01224-000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Indacaterol
Indacaterol via Breezhaler® device once a day
Other Names:
  • Onbrez™
  • Onbrize™
Active Comparator: 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.
Drug: Tiotropium
Tiotropium via Respimat® device once a day
Other Names:
  • Spiriva®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149BBR02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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