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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Tiotropium
Indacaterol
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Breezhaler, Respimat, Indacaterol, Tiotropium

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indacaterol (QAB149) Breezhaler®

Tiotropium Respimat®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Correctly Using the Device After One Week of Handling
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
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
Number of Participants With Preference for Either Device
Participants answered a single question to determine their device preference.
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.

Full Information

First Posted
September 12, 2012
Last Updated
January 23, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01727024
Brief Title
Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
Acronym
INHALATOR
Official Title
Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Breezhaler, Respimat, Indacaterol, Tiotropium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol (QAB149) Breezhaler®
Arm Type
Experimental
Arm Description
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.
Arm Title
Tiotropium Respimat®
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Tiotropium
Other Intervention Name(s)
Spiriva®
Intervention Description
Tiotropium via Respimat® device once a day
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Other Intervention Name(s)
Onbrez™, Onbrize™
Intervention Description
Indacaterol via Breezhaler® device once a day
Primary Outcome Measure Information:
Title
Number of Participants Who Correctly Used the Device at the Start of Handling the Device
Description
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 Outcome Measure Information:
Title
Number of Participants Correctly Using the Device After One Week of Handling
Description
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 7
Title
Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire
Description
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
Title
Number of Participants With Preference for Either Device
Description
Participants answered a single question to determine their device preference.
Time Frame
day 7
Title
Number of Participnats With Difficulties Experienced When Handling the Devices
Description
Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Goiania
State/Province
GO
ZIP/Postal Code
74110-030
Country
Brazil
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-281
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88040-970
Country
Brazil
Facility Name
Novartis Investigative Site
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01224-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30366585
Citation
Oliveira MVC, Pizzichini E, da Costa CH, Fritscher CC, Vianna EO, Teixeira PJZ, Stirbulov R, Rabahi MF, Pinho NC. Evaluation of the preference, satisfaction and correct use of Breezhaler(R) and Respimat(R) inhalers in patients with chronic obstructive pulmonary disease - INHALATOR study. Respir Med. 2018 Nov;144:61-67. doi: 10.1016/j.rmed.2018.10.006. Epub 2018 Oct 9.
Results Reference
derived

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

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