A clinical trial to comrare the effects of 3% and 7% hypertonic saline on lung function in children with cystic fibfosis

COMPARISON OF EFFECTS OF 3% AND 7% HYPERTONIC SALINE NEBULISATION ON LUNG FUNCTION IN CHILDREN WITH CYSTIC FIBROSIS: A RANDOMIZED CONTROLLED TRIAL

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001279

Enrollment

Registered

2010-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 7% hypertonic saline: 10 ml bd for 28 days through nebulization Control Intervention1: 3% hypertonic saline: 10ml bd for 28 days through nebulization

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
PRIMARY OUTCOME VARIABLE: ?Difference in the mean FEV1 between the two groups at day 14 and 28. Timepoint: 2 weeks and 4 weeks	—

Secondary

Measure	Time frame
SECONDARY OUTCOME VARIABLES: ?Difference in the mean FVC between the two groups at day 14 and 28 ?Difference in the mean of the results of 3 minutes step test between the two groups Timepoint: 2 weeks and 4 weeks	—

Countries

India

Contacts

Public ContactDr.S.K.Kabra

skkabra@hotmail.com01126594610

Outcome results