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临床试验/CTRI/2019/01/016940
CTRI/2019/01/016940招募中1 期

A study to assess the effect of non-asthmatic allergic rhinitis on pulmonary functions

未提供1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2019年10月1日最近更新:

试验速览

阶段
1 期
状态
招募中
入组人数
63
试验地点
1
主要终点
DETECT SUB CLINICAL CHANGES IN PULMONARY FUNCTION PARAMETERS IN SUBJECTS WITH ALLERGIC RHINITIS

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

DETECT SUB CLINICAL CHANGES IN PULMONARY FUNCTION PARAMETERS IN SUBJECTS WITH ALLERGIC RHINITIS

时间窗: AT THE FIRST OUT PATIENT VISIT, NO FOLLOW UP VISITS WILL BE ADVICED FOR THE STUDY

次要结局

未报告次要终点

研究者

发起方
未提供

研究点 (1)

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