24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD

CompletadoFase 4ClinicalTrials.gov

ID: NCT02055352Tipo: INTERVENTIONALInicio: 30 de may de 2014Fin estimado: 26 de ene de 2016

Traducción no disponible, mostrando original

Resumen

To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Patients able to read and complete
Written informed consent must be obtained before any assessment is performed
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.

Criterios de exclusión

Use of other investigational drugs within 30 days
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.

Intervenciones

drug

Budesonide

Budesonide 400 mcg twice a day via Breezhaler® device

drug

Fluticasone

Fluticasone 250 mcg twice daily via Accuhaler® device

drug

Indacaterol

Indacaterol 150 mcg once daily via Breezhaler® device

drug

Salmeterol

Salmeterol 50 mcg twice daily via Diskus® device

Ubicaciones

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

Patrocinadores

PrincipalNovartis Pharmaceuticals

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