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

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ClinicalTrials.gov Identifier: NCT01727024
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : January 6, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Tiotropium Drug: Indacaterol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : April 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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Arms and Interventions
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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 Name: Spiriva®


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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


  3. Number of Participants With Preference for Either Device [ Time Frame: day 7 ]
    Participants answered a single question to determine their device preference.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727024


Locations
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Brazil
Novartis Investigative Site
Goiania, GO, Brazil, 74110-030
Novartis Investigative Site
Belo Horizonte, MG, Brazil, 30130-100
Novartis Investigative Site
Belo Horizonte, MG, Brazil, 30150-281
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20551-030
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90020-090
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site
Florianopolis, SC, Brazil, 88040-970
Novartis Investigative Site
Ribeirao Preto, SP, Brazil, 14048-900
Novartis Investigative Site
Sao Paulo, SP, Brazil, 04039-004
Novartis Investigative Site
São Paulo, SP, Brazil, 01224-000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01727024    
Other Study ID Numbers: CQAB149BBR02
First Posted: November 15, 2012    Key Record Dates
Results First Posted: January 6, 2017
Last Update Posted: January 24, 2017
Last Verified: January 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breezhaler
Respimat
Indacaterol
Tiotropium
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action