The main purpose of this study is to compare spirometry and oscillometry tests before and after anti reflux therapy. A total of 30 patients with GERD (without history of cardio pulmonary disease and smoking) will receive omeprazol, 40 mg, twice daily, for 12 weeks. Pulmonary function tests, including spirometry and oscillometry, were performed before and after the treatment and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102035749N1
Registration date:2011-03-15, 1389/12/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-15, 1389/12/24
Registrant information
Name
Masoumeh Hosaini
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8431
Email address
hosaini.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between spirometry and oscillation techniques result before and after gastroesophageal reflux disease treatment
Public title
Comparison between spirometry and oscillation techniques result before and after gastroesophageal reflux disease treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: GERD disease confirmed with endoscopy
Exclusion criteria: history of chronic heart disease, history of airway disease, pregnancy, smoking, liver disease
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Ahvaz Jundishapur University
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
3135
Health conditions studied
1
Description of health condition studied
Comparison between spirometry and ososcillation techniques
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
spirometry
Timepoint
before intervention and 3 months after intervention
Method of measurement
PFT
2
Description
Oscillometry
Timepoint
before intervention and 3 months after intervention
Method of measurement
PFT
Secondary outcomes
empty
Intervention groups
1
Description
Omperazole, 40 mg twice a day, for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahwaz
Full name of responsible person
Masoumeh Hosaini Askarabadi
Street address
Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Masoumeh Hosaini Askarabadi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Ahwaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Hosaini Askarabadi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1373 8431
Fax
Email
hosaini.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medicine Sciences
Full name of responsible person
Dr. Ismaeel Idani
Position
Assistant professor
Other areas of specialty/work
Street address
Internal Medicine Ward , Imam Khomeini Hospital
City
Ahwaz
Postal code
Phone
+98 61 1373 8431
Fax
Email
esmaileidani@GMAIL.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Hosaini Askarabadi
Position
Internal resident
Other areas of specialty/work
Street address
Golestan Hospital
City
Ahwaz
Postal code
Phone
+98 61 1373 8431
Fax
Email
hosaini.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)