Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchiectasis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: Double-blind Placebo-controlled trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Younger than 318 years
- Gender
- Both males and females
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 ( ...
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: 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. 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) 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.
Tracking Information
- NCT #
- NCT04765033
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Anna M Nathan UMMC