Health Condition 1: J471- Bronchiectasis with (acute) exacerbation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: I. Subjects with clinical suspicion of bronchiectasis (daily signs/symptoms, such as cough, sputum production, haemoptysis or had at least one pulmonary exacerbation requiring antibiotic treatment in the past year). II. Subjects with confirmed diagnosis of bronchiectasis on high-resolution computed tomography.
Exclusion criteria
Exclusion criteria: I. Patients who have received or receiving antibiotics prolonged (more than four weeks) macrolide therapy during the previous 1 months of screening for the study. II. Patients who have received or receiving corticosteroids within 1 months of screening of the study. III. Patients having CT findings consistent with traction bronchiectasis due to pulmonary fibrosis or cystic fibrosis at the screening. IV. Patients having CT findings with chronic pulmonary aspergillosis or allergic bronchopulmonary aspergillosis at the screening. V. Patients having a diagnosis of active pulmonary tuberculosis (microbiological or radiological evidence) at the screening. VI. Subjects who refuse to give their consent to take part in the study. VII. Female subjects who are pregnant, planning for pregnancy in next month or are lactating.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the longitudinal changes in CT features in the patients with bronchiectasis. 2. To assess and compare the lung functions (pre-bronchodilator and post-bronchodilator forced vital capacity, forced expiratory volume at 1 sec, FEV1) between the two-intervention arm. Timepoint: 6 months | — |
Primary
| Measure | Time frame |
|---|---|
| Reduction in the frequency of protocol-defined pulmonary exacerbations.Timepoint: First 6 months after the completion of intervention. | — |
Countries
India
Contacts
AIIMS, NEW DELHI