FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/01/016940 [Registered on: 07/01/2019] Trial Registered Prospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the effect allergic rhinitis in a non asthmatic individual on the lung functions 
Scientific Title of Study   A study to assess the effect of non-asthmatic allergic rhinitis on pulmonary functions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ahmed Jalwa C 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of ENT, Kasturba Medical College, Tiger circle road, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9633457667  
Fax    
Email  jalwapalakki049@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rohit Singh 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of ENT, Kasturba Medical College, Tiger circle road, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9633457667  
Fax    
Email  rohit.singh@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ahmed Jalwa C 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of ENT, Kasturba Medical College, Tiger circle road, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9633457667  
Fax    
Email  jalwapalakki049@gmail.com  
 
Source of Monetary or Material Support  
Kasturba medical college and kasturba hospital institutional thesis grand 
 
Primary Sponsor  
Name  Nil 
Address  nil 
Type of Sponsor  Other [Nil] 
 
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 
Ahmed Jalwa C  Kasturba medical college  Tiger circle road, Madhav Nagar, Manipal - 576104
Udupi
KARNATAKA 
9633757667

jalwapalakki049@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients with features of allergic rhinitis
Age group 20-55 years
SFAR scoring of 7 or more 
 
ExclusionCriteria 
Details  History of asthma or bronchitis
History of smoking, immunotherapy
Treatment for Allergic Rhinitis in the last four weeks.
Subacute or chronic cardiorespiratoryDISEASES
chest wall disease
infectious disease including pulmonary TB
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
DETECT SUB CLINICAL CHANGES IN PULMONARY FUNCTION PARAMETERS IN SUBJECTS WITH ALLERGIC RHINITIS  AT THE FIRST OUT PATIENT VISIT, NO FOLLOW UP VISITS WILL BE ADVICED FOR THE STUDY 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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   Phase 1 
Date of First Enrollment (India)   10/01/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Allergic rhinitis, beginning right from childhood, is a global health problem. According to literature, allergic rhinitis has been found association with asthma and other allergic manifestations.In this study, by comparing pulmonary function test in Allergic and Non-Allergic subjects, we like to find out significance and prognostic importance of pulmonary function test in Allergic rhinitis. This study adds in the existing knowledge that even if the individual or patient is not asthmatic, but with subclinical changes in PFT indices these patients are in need of regular follow up.

         Inclusion criteria-

Patients presenting to Department of ENT – Head and Neck Surgery with features of allergic rhinitis in the age group of 20-55 years

SFAR score >/= 7

 

Exclusion criteria-

A history of asthma or bronchitis

A history of current or previous smoking, immunotherapy, anatomic nasal abnormalities

Any treatment for Allergic Rhinitis in the last four weeks.

Any subacute or chronic cardiorespiratory/ chest wall disease/ infectious disease including pulmonary TB

Biological materials required: Nil

Cases - Subjects in the age group of 20-55years with a diagnosis of Allergic Rhinitis confirmed by clinical history, clinical examination, SFAR score >/= 7

Pulmonary function assessment of the subjects in the Department of Respiratory Medicine

Done on a single visit and no repeat visit advised to the subjects for the study

 

Control – Retrospective data of the age matched healthy individuals will be analysed for the pulmonary function parameters

Individuals with SFAR score of less than 7

 

Pulmonary function parameters including Forced vital capacity (FVC), Forced expiratory volume in the first second (FEV1), Peak expiratory flow (PEF) and Forced expiratory flow at 25 – 75% of vital capacity (FEF25-75%) will be assessed. Pulmonary Function Test (PFT) is not a standard of care procedure for the subject and so, would consume half an hour in addition. The procedure is payable by the principal investigator or sponsor.

 

FEV1 and FVC were expressed as % predicted and were considered abnormal if < 80% predicted.  FEF25-75 was considered abnormal if less than 65% predicted

 

Comparing pulmonary function test in Allergic and Non-Allergic subjects

PROCEDURE OF RECRUITING SUBJECTS TO THE STUDY

The cases and controls will be recruited from the subjects in the age group of 20-55 years visiting the Department of ENT – Head and Neck surgery and/or Department of Respiratory Medicine, KMC Manipal. In addition, controls will be recruited from the retrospective data of healthy individuals available in the institute. The selected cases and controls will be encouraged to take part in the study, after providing the participant information sheet. Subjects willing for the study will be recruited after obtaining their written and informed consent in the informed consent form. The participants will be interviewed in the local language using a pretested study questionnaire. The format of the prescribed study is as follows:

DEPARTMENT OF ENT : Clinical History and examination for features of allergic rhinitis followed by SFAR scoring                                               

DEPARTMENT OF RESPIRATORY MEDICINE: Spirometry (Pulmonary function test)

 

Outcome measures: Detect subclinical changes in pulmonary function parameters in subjects with non-asthmatic allergic rhinitis

 
Close