| CTRI Number |
CTRI/2024/10/075492 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare hypertonic saline nebulization versus bicarbonate nebulization for improving lung function in children with cystic fibrosis |
|
Scientific Title of Study
|
Bicarbonate versus
hypertonic saline nebulization
for improving lung function in children with cystic fibrosis:
A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasudha Kohli |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of medical sciences, Delhi |
| Address |
PICU, First floor, Mother and child block, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868204014 |
| Fax |
|
| Email |
kohli.vasudha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kana Ram Jat |
| Designation |
Associate Professor |
| Affiliation |
All Delhi |
| Address |
8th floor, Mother and child block, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868152426 |
| Fax |
|
| Email |
drkanaram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kana Ram Jat |
| Designation |
Associate Professor |
| Affiliation |
All Delhi |
| Address |
8th floor, Mother and child block, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868152426 |
| Fax |
|
| Email |
drkanaram@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCE, DELHI |
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Delhi, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kana Ram Jat |
All India Institute of Medical Sciences, Delhi |
Room number 208, Pediatric Chest Clinic, 2nd floor, New RAK OPD
New Delhi
DELHI |
09868152426
drkanaram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J479||Bronchiectasis, uncomplicated, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3% saline nebulization |
4ml solution of 3% saline nebulization will be used for nebulization for enrolled patients randomized to control arm, twice daily, for 3 months. Nebulization will be preceded by salbutamol nebulization and followed by chest physiotherapy and nebulization with inhaled steroids. |
| Intervention |
8.4% Sodium bicarbonate nebulization |
4ml solution of 8.4% sodium bicarbonate
nebulization will be used for nebulization for enrolled patients twice daily for 3 months. Nebulization will be preceded by salbutamol nebulization and will be followed by chest physiotherapy and inhaled steroid nebulization. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children 5-18 years of age, diagnosed with
Cystic fibrosis, on regular chest physiotherapy for at least 3
months |
|
| ExclusionCriteria |
| Details |
Children with history of adverse reaction to hypertonic saline or sodium bicarbonate, or history of exposure to inhaled sodium bicarbonate in preceding 3 months, or having acute severe exacerbation at the time of screening or very severe pulmonary dysfunction (FEV1 less than 30% predicted) or inability to perform spirometry or home oxygen therapy at the time of screening or within preceding 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare changes in pulmonary
function (FEV1) following 3 months of nebulization with sodium
bicarbonate compared to hypertonic saline nebulization in
children with cystic fibrosis age 5-18 years. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of 3 months of
nebulization with sodium bicarbonate compared to hypertonic
saline nebulization in children with cystic fibrosis age 5-18 years
on Ease of sputum expectoration |
3 months |
To study the effect of 3 months of
nebulization with sodium bicarbonate compared to hypertonic
saline nebulization in children with cystic fibrosis age 5-18 years
on Frequency of Pulmonary exacerbations requiring
hospitalization or i/v or oral antibiotic use. |
3 months |
To study the effect of 3 months of
nebulization with sodium bicarbonate compared to hypertonic
saline nebulization in children with cystic fibrosis age 5-18 years
on Clinical severity score using Modified N. Huang Clinical
Severity Score |
3 months |
To study the effect of 3 months of
nebulization with sodium bicarbonate compared to hypertonic
saline nebulization in children with cystic fibrosis age 5-18 years
on Airway colonization with respiratory pathogens commonly
colonizing airway in CF |
3 months |
To study the effect of 3 months of
nebulization with sodium bicarbonate compared to hypertonic
saline nebulization in children with cystic fibrosis age 5-18 years
on adverse effects |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cystic fibrosis is an inherited disorder characterized by dysfunction of CFTR, an anion channel present in a diverse range of epithelial tissues. Specifically in the lungs, it plays a role in airway hydration and pH regulation. CFTR dysfunction leads to defective mucociliary clearance causing thick mucus plugging and repeated infections. Although survival is gradually improving, majority patients still succumb to respiratory failure. In resource limited settings, there are only limited affordable therapies. CFTR modulators and dornase alpha are expensive and not readily available, leaving chest physiotherapy and hydrator therapies (nebulization with 3%saline) as the mainstay of treatment of CF patients in our country. Recent studies have highlighted the potential therapeutic benefits of bicarbonate inhalation in CF. Bicarbonate, a key ion transported by CFTR, plays a crucial role in modulating airway pH and influencing mucin properties. Alkalinization of airway surface liquid with bicarbonate has shown promise in preclinical models and early clinical trials, demonstrating improved mucus rheology, enhanced drug permeation, and reduced bacterial biofilm formation. Sodium bicarbonate, is an inexpensive, readily available drug. Due to its high osmolarity, with an additional useful property of alkaline pH, it may perform better than hypertonic saline for improving lung health in CF patients in poor resource settings. But no RCT till date has compared 3% NS nebulization with sodium bicarbonate in patients with CF with respect to clinical outcomes. The current study will explore repurposed novel utilization of an easily available drug. As CF is a lifelong disease, long-term improvement in lung health and quality of life will be multi-fold, if detected. |