FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 
Close