| CTRI Number |
CTRI/2025/10/096677 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Estimation of Fractional Exhaled Nitric Oxide and Nasal Nitric Oxide measured among Healthy Adults |
|
Scientific Title of Study
|
Estimation of Fractional Exhaled Nitric Oxide and Nasal Nitric Oxide measured by
Electrochemical Sensor among Healthy Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sajal De |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences Raipur |
| Address |
Dept of Pulmonary Medicine
All India Institute of Medical Sciences
G E Road
Raipur G E Road, Tatiabndh Raipur CHHATTISGARH 492099 India |
| Phone |
9406573825 |
| Fax |
|
| Email |
sajalde@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sajal De |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences Raipur |
| Address |
Dept of Pulmonary Medicine
All India Institute of Medical Sciences
G E Road
Raipur G E Road, Tatiabndh
CHHATTISGARH 492099 India |
| Phone |
9406573825 |
| Fax |
|
| Email |
sajalde@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Sajal De |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences Raipur |
| Address |
Dept of Pulmonary Medicine
All India Institute of Medical Sciences
G E Road
Raipur G E Road, Tatiabndh
CHHATTISGARH 492099 India |
| Phone |
9406573825 |
| Fax |
|
| Email |
sajalde@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Material support by AIIMS Raipur |
|
|
Primary Sponsor
|
| Name |
Not a sponsored study Institutional resource will be used for the tests |
| Address |
AIIMS Raipur |
| 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 |
| Sajal De |
All India Institute of Medical Sciences Raipur |
Dept of Pulmonary Medicine
All India Institute of Medical Sciences
G E Road
Raipur
G E Road, Tatiabndh Raipur CHHATTISGARH |
09406573825
sajalde@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients aged 18 years and not having any current or past respiratory disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 18 years and not having any current or past respiratory disease |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Unacceptable FeNO/nNO data, defined as a confidence index of the test (a quality control measure) less than 80%.
History of allergic rhinitis/acute or chronic sinusitis/nasal polyp, bronchial asthma, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Values of concentration of Nitric Oxide present in expired air
Concentration of Nasal nitric oxide |
At the time of test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To develop & evaluate regression models that best explain the variation in normative fractional exhaled nitric oxide (FeNO) & nasal nitric oxide (nNO) values among healthy adults.
|
After data collection |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Nitric oxide (NO) plays a vital role in the physiology of the respiratory system, acting as a biomarker of airway inflammation. Two key noninvasive measurements—fractional exhaled nitric oxide (FeNO) and nasal nitric oxide (nNO)—are increasingly used to evaluate respiratory and nasal pathology. NO is primarily produced by inducible nitric oxide synthase (iNOS), which is expressed in various cells, including epithelial cells, macrophages, neutrophils, endothelial cells, and vascular smooth muscle cells [1]. The majority of the NO of the lung originates from the central airways, with minimal contribution from the alveolar or peripheral regions. While nNO serves as a marker for upper airway inflammation and is notably reduced in disorders like primary ciliary dyskinesia and increased in allergic rhinitis. The existing reference values of FeNo and nNO have largely been derived from non-Indian populations, primarily Caucasian cohorts. Ethnic, environmental, and anthropometric differences significantly influence NO levels, and therefore, applying reference standards from other populations may not yield accurate clinical interpretations in the Indian context. Moreover, variations in measurement techniques and devices, such as chemiluminescence versus electrochemical sensors, further impact the generalizability of these values. This study aims to fill this gap by determining the reference ranges and exploring the demographic and physiological predictors of FeNO and nNO levels among healthy Indian adults using standardized measurement techniques. |