| CTRI Number |
CTRI/2019/01/017171 [Registered on: 21/01/2019] Trial Registered Prospectively |
| Last Modified On: |
17/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Distribution of blood eosinophils in patients with chronic
obstructive pulmonary disease (COPD) living in areas of
endemic helminth infections: a cross-sectional study in South-
East Asia (Helminth study) |
|
Scientific Title of Study
|
Distribution of blood eosinophils in patients with chronic obstructive pulmonary disease (COPD) living in areas of endemic helminth infections:a cross-sectional study in South East Asia (Helminth study) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2018N359600_00 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jitendra Rathore |
| Designation |
Project Manager |
| Affiliation |
George Clinical |
| Address |
George Clinical India PVT
Plot No 5 Prestige Khoday Towers 12th Floor Raj Bhavan Road
Bangalore
KARNATAKA
560001
India |
| Phone |
9959744472 |
| Fax |
|
| Email |
jrathore@georgeclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jitendra Rathore |
| Designation |
Project Manager |
| Affiliation |
George Clinical |
| Address |
George Clinical Ind Pvt
Plot No 5 Prestige Khoday Towers 12th Floor Raj Bhavan Road
Bangalore
KARNATAKA
560001
India |
| Phone |
9959744472 |
| Fax |
|
| Email |
jrathore@georgeclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Jitendra Rathore |
| Designation |
Project Manager |
| Affiliation |
George Clinical |
| Address |
George Clinical Ind Pvt
Plot No 5 Prestige Khoday Towers 12th Floor Raj Bhavan Road
Bangalore
KARNATAKA
560001
India |
| Phone |
9959744472 |
| Fax |
|
| Email |
jrathore@georgeclinical.com |
|
|
Source of Monetary or Material Support
|
| George Clinical
Plot No. 5 Prestige Khoday Towers 12th Floor Raj Bhavan Road
Bangalore 560 001 Karnataka India
|
|
|
Primary Sponsor
|
| Name |
Glaxo Smith Kline |
| Address |
GlaxoSmithKline Research & Development Limited 980 Great West Road Brentford Middlesex TW8 9GS UK |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Angira Dasgupta |
BR Singh Hospital and Centre for Medical Education and Research |
Departments of Medicine and Pulmonary Medicine, Kolkata, 700014, West Bengal
Kolkata
WEST BENGAL |
9002021543
angiradasgupta@gmail.com |
| Dr Devasahayam Christopher |
Christian Medical College |
Christian Medical College, Department of Pulmonary Medicine, Ida Scudder Road,Vellore, 632 004 TAMILNADU
Vellore
TAMIL NADU |
4162283373
djchris@cmcvellore.ac.in |
| Dr Sarbani Ghosh |
IPGME & R and SSKM Hospital |
Department of Medicine, 4th Floor, Ronald Ran Building, Arsenic Clinic, 244, AJC Bose Road, Kolkata, 700020
Kolkata
WEST BENGAL |
9433295970
drsrabanighosh73@gmail.com |
| Dr M Koushik Muthu Raja |
SRI Ramachandra Medical Centre |
Department of Pulmonary Medicine No.1 Ramachandra Nagar, Porur
Chennai, Tamil Nadu,
India 600 116
Chennai
TAMIL NADU |
9894678080
srmcclinicalresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institute Medical Science banaras Hindu university |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Review Board |
Submittted/Under Review |
| IPGMER & R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J708||Respiratory conditions due to other specified external agents, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female at least 40 years old
2.Capable of giving written informed consent
3.Have a prior diagnosis of COPD documented in the medical record
4. Have COPD diagnosis confirmed by post-bronchodilator spirometry test at
enrolment
5. Have moderate-severe airflow limitation defined as a forced expiratory volume in
one second (FEV1)/forced vital capacity (FVC) less than 0.7 and FEV1 less than
80% predicted on post-bronchodilator spirometry at enrolment |
|
| ExclusionCriteria |
| Details |
1. Onset of COPD symptoms before 30 years of age
2. Experienced an acute exacerbation of COPD (defined as an acute worsening of
symptoms that result in treatment with an antibiotic or oral steroid) within the
four weeks prior to, or on the date of, enrolment
3. Have diagnosed asthma over the past 12 months or have experienced asthma
symptoms with a clinical history suggestive of asthma in the past 12 months
4. Have cystic fibrosis, pulmonary fibrosis or bronchiectasis documented in the
medical record
5. Have active tuberculosis or are taking medication for tuberculosis
6. Have had pulmonary resection surgery
7. Are pregnant (women of childbearing potential with positive urine pregnancy test
will be excluded) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will include circulating blood eosinophil count; for each patient two
estimates will be derived: cells per μL, and as % total white blood cell count (WCC). |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Primary outcome will include circulating blood eosinophil count; for each patient two
estimates will be derived: cells per μL, and as % total white blood cell count (WCC). |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
30/01/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will consist of a single clinic visit during which data will be collected by spirometry, blood, stool and urine tests, review of medical history, review of COPD exacerbation history, and review of concomitant or recent medications. Participants’ self-report will be used to complement medical records and to collect information on previous exposure to dust, fumes and biomass smoke. This study aims to recruit a total of 500 participants with COPD from India. COPD symptoms must have started after 30 years of age. Areas with high prevalence of helminth infection will be selected with the assumption that approximately 20% to 30% of recruited patients will have helminth infections. Recruitment is estimated to take six months. The study will be conducted at established healthcare sites with respiratory specialists who have access to bronchodilators and spirometers. Sites will also have a local laboratory capable of performing haematology testing and detection of helminth infection. Rural sites will be preferred due to the increased prevalence of helminth infections in these areas. Study investigators will invite patients from their practices to participate in the study. Patients who are diagnosed with a helminth infection during this study will be referred to a hospital or health care centre for treatment according to institutional practice.
|