Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD
NCT ID: NCT02055352
Last Updated: 2017-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
222 participants
INTERVENTIONAL
2014-05-30
2016-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Budesonide/indacaterol
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
Budesonide
Budesonide 400 mcg twice a day via Breezhaler® device
Fluticasone
Fluticasone 250 mcg twice daily via Accuhaler® device
Indacaterol
Indacaterol 150 mcg once daily via Breezhaler® device
Salmeterol
Salmeterol 50 mcg twice daily via Diskus® device
Fluticasone / salmeterol
Fixed combination of fluticasone and salmeterol
Fluticasone
Fluticasone 250 mcg twice daily via Accuhaler® device
Salmeterol
Salmeterol 50 mcg twice daily via Diskus® device
Interventions
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Budesonide
Budesonide 400 mcg twice a day via Breezhaler® device
Fluticasone
Fluticasone 250 mcg twice daily via Accuhaler® device
Indacaterol
Indacaterol 150 mcg once daily via Breezhaler® device
Salmeterol
Salmeterol 50 mcg twice daily via Diskus® device
Eligibility Criteria
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Inclusion Criteria
* Outpatients with stable COPD groups C and D according to the 2011 GOLD Guidelines.
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Patients with a history of at least one exacerbation.
* Patients able to read and complete
Exclusion Criteria
* Patients with a history of hypersensitivity to any of the study drugs
* History or current diagnosis of ECG abnormalities
* Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range
* Patients who have not achieved an acceptable spirometry result at Visit 1
* Patients with a body mass index (BMI) of more than 40 kg/m2
* Patients with lung cancer or a history of lung cancer
* Patients with a history of malignancy of any organ system
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
* Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers)
* Patients that are uncontrolled or unstable on permitted therapy, who in the opinion of the investigator, have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
* Patients requiring oxygen therapy for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
* Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension
* Patients with a known diagnosis of Alpha-1 Antitrypsin deficiency.
* Patients with history of lung surgery
* Patients who are participating in the active phase of a supervised pulmonary rehabilitation program.
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
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Novartis Investigative Site
Florida, Buenos Aires, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, Argentina
Novartis Investigative Site
Vicente López, Buenos Aires, Argentina
Novartis Investigative Site
Zárate, Buenos Aires, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As, Argentina
Novartis Investigative Site
Santa Rosa, La Pampa Province, Argentina
Novartis Investigative Site
Salta, Salta Province, Argentina
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Bernardo do Campo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Rancagua, Rancagua, Chile
Novartis Investigative Site
Santiago, Santiago Metropolitan, Chile
Novartis Investigative Site
Santo Domingo, Republica Dominicana, Dominican Republic
Novartis Investigative Site
Santo Domingo, Republica Dominicana, Dominican Republic
Novartis Investigative Site
Guayaquil, Guayas, Ecuador
Novartis Investigative Site
San Pedro Sula, Honduras, Honduras
Novartis Investigative Site
Tegucigalpa, Honduras, Honduras
Novartis Investigative Site
León, Guanajuato, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Panama City, Provincia de Panamá, Panama
Countries
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Other Identifiers
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CQAB149BAR01
Identifier Type: -
Identifier Source: org_study_id
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