A clinical trial to comrare the effects of 3% and 7% hypertonic saline on lung function in children with cystic fibfosis
Phase 1
- Registration Number
- CTRI/2010/091/001279
- Lead Sponsor
- Sumita Gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1.Patients aged between 6-16 years of either sex with confirmed diagnosis of cystic fibrosis(sweat chloride more than or equal to 60mEq/l)
2.Ability to perform reproducible pulmonary function test.
3.Regular performance of chest physiotherapy at home.
4.A regular medication regime for at least last 14 days.
Exclusion Criteria
1.Hypersensitivity to hypertonic saline (FEV1 falls by more than 15% from baseline following the test dose) 24.
2.Had a lower respiratory tract infection requiring antibiotics or change in bronchodilator treatment during the last 4 weeks prior to enrolment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY OUTCOME VARIABLE:<br>?Difference in the mean FEV1 between the two groups at day 14 and 28.<br><br>Timepoint: 2 weeks and 4 weeks
- Secondary Outcome Measures
Name Time Method SECONDARY OUTCOME VARIABLES:<br>?Difference in the mean FVC between the two groups at day 14 and 28<br>?Difference in the mean of the results of 3 minutes step test between the two groups<br>Timepoint: 2 weeks and 4 weeks