A study to assess the effect allergic rhinitis in a non asthmatic individual on the lung functions

Phase 1

Recruiting

Conditions: Allergic rhinitis, unspecified,

Registration Number: CTRI/2019/01/016940

Brief Summary: 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 â€“ 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 â€“ 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 â€“ 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 â€“ 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 63

Inclusion Criteria

Patients with features of allergic rhinitis Age group 20-55 years SFAR scoring of 7 or more.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method

Trial Locations

Locations (1): Kasturba medical college
🇮🇳
Udupi, KARNATAKA, India
Kasturba medical college
🇮🇳Udupi, KARNATAKA, India
Ahmed Jalwa C
Principal investigator
9633757667
jalwapalakki049@gmail.com