We aimed to evaluate the effects of anti-reflux therapy with omeprazole on gastrointestinal and respiratory symptoms in warfare victims of exposure to mustard gas with chronic cough. Study was conducted on 60 Iranian chemical warfare victims with a history of exposure to mustard gas and symptoms of chronic cough (more than 3 weeks) and GERD between 2008 and 2011. Current smokers and those with previous history of smoking and also those under recent anti-reflux therapy were not included. Patients were randomized to receive omeprazole (20 mg twice daily) for four months followed by one month washout and four months of placebo (OP), or the reverse treatment (PO). Assessments included GERD and cough symptoms as primary outcomes, and quality of life, and pulmonary function using spirometry as secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072510398N1
Registration date:2012-08-17, 1391/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
Mohammad Hassan Emami
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66801680098311
Email address
mh_emami@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Chemical Injuries Research Cennter
Expected recruitment start date
2008-01-01, 1386/10/11
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Anti-reflux Therapy with Omeprazole on Gastrointestinal and Respiratory Symptoms in Victims of Mustard Gas Exposure with Chronic Cough
Public title
Treatment of Gastro-esophageal Reflux Disease in Victims of Mustard Gas Exposure with Chronic Cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male; Chemical warfare victim; Having a history of exposure to mustard gas; Having symptoms of chronic cough (more than 3 weeks); Having symptoms of GERD; Willing to participate
Exclusion criteria:
Current smokers; Having previous history of smoking; Being under recent anti-reflux therapy; Contraindication for using omeprazole
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences
Street address
Molla Sadra Ave., Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-08-01, 1389/05/10
Ethics committee reference number
86414
Health conditions studied
1
Description of health condition studied
Gastro-oesophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-oesophageal reflux disease
Primary outcomes
1
Description
GERD Symptoms
Timepoint
Before and After the Trial
Method of measurement
Questionnaire
2
Description
Cough Symptoms
Timepoint
Every one month
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and After the Trial
Method of measurement
Questionnaire
2
Description
Pulmonary Function
Timepoint
Before and After the Trial
Method of measurement
Spirometry
Intervention groups
1
Description
Omeprazole (20 mg twice daily) for four months followed by one month washout and four months of placebo
Category
Treatment - Drugs
2
Description
Reverse treatment: Placebo twice daily for four months, then one month washout period, then omeprazole 20 mg twice daily for four months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Almomenin Hospital
Full name of responsible person
Dr. Mohammad Talaei
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Mostafa Ghanei
Street address
Molla Sadra Ave., Baqiyatallah University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences and Poursina Hakim Research Institute
Full name of responsible person
Dr Mohammad Talaei
Position
MD, MPH, Research Assistant
Other areas of specialty/work
Street address
#23, Fribourg Crossroads, Azadi Ave.
City
Isfahan
Postal code
Phone
+98 31 1668 0168
Fax
Email
mtalaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, and Poursina Hakim Research Institute
Full name of responsible person
Dr. Mohammad Hassan Emami
Position
MD, Associate Prof. of Gastroenterology
Other areas of specialty/work
Street address
#23, Fribourg Crossroads, Azadi Ave.
City
Isfahan
Postal code
Phone
+98 31 1668 0168
Fax
Email
mh_emami@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences, and Poursina Hakim Research Institute
Full name of responsible person
Dr. Mohammad Talaei
Position
MD, MPH, Research Assistant
Other areas of specialty/work
Street address
#23, Fribourg Crossroads, Azadi Ave.
City
Isfahan
Postal code
Post Box: 81465-1798
Phone
+98 31 1668 0168
Fax
+98 31 1668 0168
Email
mtalaei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)