Comparison of the effectiveness of 3% saline nebulization prior to chest physiotherapy over conventional physiotherapy in children with non cystic fibrosis bronchiectasis

Comparison of the effectiveness of hypertonic saline nebulization prior to chest physiotherapy over conventional physiotherapy in children with non cystic fibrosis bronchiectasis -Randomized Control Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2018/010

Enrollment

Unknown

Registered

2018-03-20

Start date

2018-03-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Non Cystic Fibrosis Bronchiectasis

Interventions

Study setting: Lady Ridgeway Hospital Colombo Method of randomization: Block randomization Intervention arm: Nebulized 3% sodium chloride 3 ml before physiotherapy for a period of 2 months Control

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 5-15 years with the clinical and radiological diagnosis of Bronchiectasis. 2. Negative sweat test

Exclusion criteria

Exclusion criteria: 1. Inability to comply with regular follow up 2. On regular hypertonic saline nebulization for one year. 3. Diagnosed with chronic colonization of Pseudomonas (2 or more sputum cultures positive) 4. Subjected to a change in antibiotic regimen within 4 weeks prior to enrollment 5. Any suspicion of hypersensitivity for any of the medications used (salbutamol, hypertonic saline) 6. Presence of typical extra pulmonary features of cystic fibrosis 7. Unable to perform spirometry test due to poor effort 8. Children who showed FEV1 <60% of expected at baseline spirometry even after a bronchodilator therapy

Design outcomes

Primary

Measure	Time frame
Directly measured FEV1 (Forced expiratory volume in one second) values using a spirometer will be compared pre and post treatment and a 10% improvement will be considered a significant change. [Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment]	—

Secondary

Measure	Time frame
Directly measured FEV1 and FVC (forced vital capacity) values using spirometry [Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment ] Six min walk test [Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment] Documented number of asthma exacerbations [Day 0, day 84 for 1st allocated intervention arm, day 84, day 168 for the 2nd allocated intervention arm (Day 168 = 4 weeks after the completion of the study)]	—

Measure

Time frame

Directly measured FEV1 and FVC (forced vital capacity) values using spirometry [Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment ] Six min walk test [Day 0, day 28, day 56, day 84, day 112, and day 140 from commencement of treatment] Documented number of asthma exacerbations [Day 0, day 84 for 1st allocated intervention arm, day 84, day 168 for the 2nd allocated intervention arm (Day 168 = 4 weeks after the completion of the study)]

—

Countries

Sri Lanka

Contacts

Public ContactDr.K.W.D.A Anuradha

Senior Registrar in Paediatric Respiratory Medicine

anujaya2008@gmail.com0112 693711 ext 201

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026