Unspecified Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Approximately 242 participants will be included in this study in approximately 35 research centers in South America In Brazil 35 patients will be enrolled.
Investigational Group: 121 patients with Ch
Drug
D27.505.519.625.050.100.200
Sponsors
Novartis Biociências S.A.
Novartis Biociências S.A.
Centro de Pesquisa em Pneumologia e Infectologia do Hospital Mãe de Deus (Centro Coordenador)
Eligibility
Inclusion criteria
Inclusion criteria: Patients both genders, age greater than 40 years in outpatient treatment with a diagnosis of COPD in groups C and D, according to the GOLD with post-bronchodilator FEV1 <60% guidelines and 30% predicted, FEV 1 / FVC post-bronchodilator <0.7; smoking for at least 10 pack-years (defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years and so on); smokers and ex-smokers are eligible; history of at least one exacerbation of COPD.
Exclusion criteria
Exclusion criteria: Patients requiring oxygen therapy for chronic hypoxemia (excluding acute exacerbation of COPD), typically with oxygen> 15 h per day; COPD exacerbation within 6 weeks prior to visit 1 or between visits 1 and 2 or the presence of infection of the upper or lower respiratory tract infection during the screening period (Visit to 2) shall be permitted to a new screening after a minimum and 6 weeks after resolution of the episode; Pulmonary disease associated, for example, (except confirmed by chest radiography and no longer active) pulmonary tuberculosis or clinically significant bronchiectasis, sarcoidosis, interstitial lung disease or pulmonary hypertension; known diagnosis of deficiency of Alpha-1 Antitrypsin; Pulmonary lobectomy; lung volume reduction or lung transplantation; participation in the active phase of a program of supervised pulmonary rehabilitation; Asthma history marked by (but not limited to):.. onset of respiratory symptoms (coughing, wheezing, shortness of breath) suggestive of asthma before age 40 and history of a diagnosis of asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is change from baseline in trough FEV1 after 12 weeks (84 days) of treatment in patients with moderate to severe COPD. FEV1 is defined as the average FEV1 23.10 min and 23.45 min after the morning dose of study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Both superiority assessment of the free combination indacaterol/budesonide over salmeterol/fluticasone on trough FEV1 after 12 weeks of treatment and the non-inferiority comparison after 24 weeks of treatment will be analyzed. | — |
Countries
Argentina, Brazil, Chile, Dominican Republic, Ecuador, Honduras, Mexico, Panama, Venezuela
Contacts
Public ContactMaurício Lutaif
Novartis Biociências S.A.
Outcome results
None listed