Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.

University of Malaya

Status and phase: Completed; Phase 4

Conditions: Bronchiectasis

Treatments: Drug: Nebulized 5% Hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04765033

2020729-8926

Details and patient eligibility

About

To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.

Secondary Aims:

To determine the:

1. Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.
2. Efficacy of nebulized 5% hypertonic saline on lung function
3. Adverse effects of nebulized 5% hypertonic saline in children

Full description

Primary Aim:

To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.

Here the investigators will be using validated pediatric cough questionnaires to asses this. Patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)

Secondary Aims:

To determine the:

1. Efficacy of nebulized 5% hypertonic saline on the airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.

   Here the investigators will be taking history on the exacerbations, use of antibiotics and healthcare utilization before and after use of the hypertonic saline. Furthermore, Nasopharyngeal swabs will be done to review possible changes in microbiota, again before and after use of the 5% HS.

2. Efficacy of nebulized 5% hypertonic saline on lung function. Here is investigators will be doing portable spirometry ( pre and post bronchodilator).

   Patients will perform at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)

3. Adverse effects of nebulized 5% hypertonic saline in children HS has been associated with side-effects. The investigators will monitor this. We will asses presence of these symptoms at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) to ensure these are from the nebulizer.

Enrollment: 46 patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients < 18 years old
• Followed up in the paediatric respiratory clinic of UMMC with a diagnosis of CSLD

Exclusion criteria

• Incomplete data or refusal to participate
• Unwell and/or unable to stop HS and/or antibiotics of any preparation other than azithromycin ( EOD
• On supplementary oxygen/home ventilation
• Poorly controlled asthma (as in the GINA guidelines) or bronchoconstriction that precedes the use of hypertonic saline.
• Oral antibiotics for less than 4 weeks before randomization for medication.
• Fall in PEFR > 20% post 5% HS challenge test or a positive HS challenge test in young children, as mentioned below.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

5% Hypertonic saline

Active Comparator group

Description:

5% hypertonic saline nebuliser 4 mls twice in a day for 3 months

Treatment:

Drug: Nebulized 5% Hypertonic saline

Placebo

Placebo Comparator group

Description:

0.9% saline nebuliser 4 mls twice in a day for 3 months

Treatment:

Drug: Nebulized 5% Hypertonic saline