| CTRI Number |
CTRI/2024/10/075591 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
To see the effect of allergens associated respiratory symptoms in COPD patients |
|
Scientific Title of Study
|
Effect of Allergic Phenotype on Respiratory Sypmtoms And Exacerbations in Patients With Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragati Tyagi |
| Designation |
1st year Resident doctor |
| Affiliation |
Department of Respiratory Medicine Sir T Hospital campus Bhavnagar |
| Address |
Department of Respiratory Medicine Sir T Hospital campus Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9016060100 |
| Fax |
|
| Email |
pragatityagi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigna Trivedi |
| Designation |
Head of Department, Department of Respiratory Medicine |
| Affiliation |
Government medical college,bhavnagar |
| Address |
Department of Respiratory Medicine
Government Medical college
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825096289 |
| Fax |
|
| Email |
drjignadave@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigna Trivedi |
| Designation |
Head of Department, Department of Respiratory Medicine |
| Affiliation |
Government medical college,bhavnagar |
| Address |
Department of Respiratory Medicine
Government Medical college
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825096289 |
| Fax |
|
| Email |
drjignadave@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sir T Hospital Bhavnagar Gujarat India 364001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Bhavnagar |
| Address |
Government Medical College Behind ST Bus Stand Bhavnagar 364001 |
| 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 |
| Dr Pragati Tyagi |
Sir-Takhtasinhji hospital Bhavnagar |
Department of Respiratory Medicine Sir-T hospital Bhavnagar
Bhavnagar
GUJARAT |
9016060100
pragatityagi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee,GovernmentMedicalCollege,Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Skin Prick test and Absolutel Eosinophil count and Serum IgE and Spirometry and Chest Xray in Suspected Allergic COPD Patients |
15 month
|
| Comparator Agent |
Spirometry and Chest Xray in Suspected non Allergic COPD Patients |
15 month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with FEVI/FVC less than 70% post bronchodilator irreversibility, diagnosed as COPD on the basis of spirometry , radiological profile(bilateral hyperinflated lung) will be considered.
Patients between 30 to 70 years of age group
Patients ready to give informed consent for inclusion in the study and skin prick test.
|
|
| ExclusionCriteria |
| Details |
Patient on oral glucocorticosteroids greater than 4weeks in 6 month duration
Patients having history of dermatography.
Patients on immunosuppresive medication,patients on monoclonal antibodies like omalizumab,patient on immunoglobulin therapy and patient taking anti histaminic drugs.
Patient with past history of severe allergic reactions and anaphylaxis.
Patient having active tuberculosis infection.
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate prevalance of sensitivity to various allergens through absolute eosinophil count , Serum IgE and skin prick test in patients of COPD
To assess correlation between allergen positivity and various respiratory symptoms in COPD patients
|
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess gender wise prevalence of sensitivity to various allergens.
To study various aspect of patient profile like occupation, family history, medications used |
15 monthd |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/10/2024 |
| 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="1"
Months="3"
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
|
Introduction
•
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous lung
condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum
production and/or exacerbations) due to abnormalities of the airways
(bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent,
often progressive, airflow obstruction.
•
Cigarette smoking is a key environmental risk factor for COPD. Cigarette
smokers have a higher prevalence of respiratory symptoms and lung function
abnormalities, a greater annual rate of decline in FEV1, and a greater COPD
mortality rate than non-smokers
•
Wood, animal dung, crop residues, and coal, typically burned in open
fires or poorly functioning stoves, may lead to very high levels of household
air pollution which is associated with COPD.
•
Atopy coming from the greek atopos, meaning “out of place “, refers to
the hereditary predisposition to produce immunoglobulin E (Ig E) against common
environmental allergens.
•
Allergic sensitization has been shown to be a significant predictor of a
faster rate of lung function decline and allergen exposure in sensitized
individuals may provoke neutrophilic bronchial inflammation, similar to the
inflammation seen in airways of patients with COPD.
•
However, whether allergy worsens respiratory symptoms in patients with
COPD remains unknown.
Why this study
is essential? •
Only 10–15% of smokers go on to
develop chronic obstructive pulmo-nary disease (COPD). The reasons for this are
likely complex and relate primarily
to three factors:
genetic susceptibility ,dose and
timing of exposure, and interactions between smoking and other environmental
factors of interest in causing the disease. •
International chronic obstructive pulmonary disease (COPD) guidelines
such as the Global Initiative for Chronic Obstructive Lung Disease (GOLD) make
no recommendations for allergy diagnosis or treatment. This absence of
recommendations may be appropriate given the lack of available evidence. •
The goal of
this study is
to consider the
epidemiologic data that atopy defined as immediate type II
hypersensitivity, and not as clinical asthma, is a risk factor for the
development of chronic obstructive lung disease.
|