â??Efficacy of doxycycline in comparison to azithromycin in adult patients with non-cystic fibrosis bronchiectasis
- Conditions
- Health Condition 1: J471- Bronchiectasis with (acute) exacerbation
- Registration Number
- CTRI/2019/01/017090
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the frequency of protocol-defined pulmonary exacerbations.Timepoint: First 6 months after the completion of intervention.
- Secondary Outcome Measures
Name Time Method 1.To evaluate the longitudinal changes in CT features in the patients with bronchiectasis. <br/ ><br> <br/ ><br>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. <br/ ><br>Timepoint: 6 months