Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients
NCT ID: NCT01727024
Last Updated: 2017-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2013-04-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
Indacaterol
Indacaterol via Breezhaler® device once a day
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.
Tiotropium
Tiotropium via Respimat® device once a day
Interventions
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Tiotropium
Tiotropium via Respimat® device once a day
Indacaterol
Indacaterol via Breezhaler® device once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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%
Exclusion Criteria
2. Pregnant or nursing women
3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Goiânia, Goiás, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Florianópolis, Santa Catarina, Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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CQAB149BBR02
Identifier Type: -
Identifier Source: org_study_id
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