Health Condition 1: null- COPD
Conditions
Interventions
Intervention1: Indacaterol: Dosage - 150microgram or 300 microgram as mentioned in package insert as per investigators discreetion
Frequency - once daily
Route - Oral inhalation using Onbrez Breezhel
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Current diagnosis of moderate COPD (GOLD stage II) according to GOLD criteria 2009 (GOLD guidelines 2009) 2. Patients starting treatment for the first time with a long-acting bronchodilator monotherapy (indacaterol monotherapy or any other LABA or LAMA monotherapy) according to local prescribing information (PI)/Summary of Product Characteristics (SmPC) 3. Patients 40 years of age or older 4. Smoking history of at least 10 pack-years 5. COPD symptoms like cough, sputum secretion, wheezing 6. Patients who agree to complete Clinical COPD Questionnaire (CCQ) 7. Patients who provide written informed consent to have their data collected and used for the purpose of this study. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care
Exclusion criteria
Exclusion criteria: 1.Previous diagnosis of asthma 2.Contraindications mentioned in the local PI/SmPC for the prescribed study drug 3.History of cancer, concomitant pulmonary disease, prolonged QT syndrome, or alpha-1-anti-trypsin deficiency 4.Pregnant or lactating women 5.Patients in acute exacerbation (requiring antibiotics or hospitalization) at study entry 6.Patients with acute/active cardiovascular disease at study entry 7.Unwillingness or inability to comply with the study requirements 8.Patients on inhaled corticosteroids (ICS) therapy at study entry or during the 3 months prior to the study entry 9.Patients using 2 different LABAs, LABA+LAMA, LABA+ICS combination or triple therapy (LAMA+LABA+ICS) 10.Patients on maintenance therapy with SABA and/or SAMA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness and patient acceptance of indacaterol compared to other long-acting bronchodilators (LABA and LAMA) by a Patient Reported Outcomes (PRO) questionnaireTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess device user friendliness for indacaterol treatment and other long acting bronchodilatorsTimepoint: 1 year;To assess safety and tolerability of indacaterol and other long acting bronchodilatorsTimepoint: 1 year;To describe patient characteristics for COPD patients treated with indacaterol and those treated with other long acting bronchodilators (LABA and LAMA)Timepoint: 1 year;To evaluate global patients and physicians satisfaction with treatmentTimepoint: 1 year;To evaluate patients adherence to indacaterol and other long acting bronchodilatorsTimepoint: 1 year | — |
Countries
Bahrain, Egypt, India, Indonesia, Kuwait, Lebanon, Philippines, Taiwan, Thailand, United Arab Emirates
Contacts
Public ContactDr Mangala Kotnis
Novartis
Outcome results
None listed