In this study 50 patients suffering from asthma who have referred to Kashan`s Beheshti Hospital in 1390 will be recruited. The patients will be observed completely by a doctor who is expert in respiratory diseases. Asthmatic patients with FEV1>=60% will be enrolled in this investigation; afterward these patients will be exposed to ultrasonic nebulizer with stable amount of nebulized hypertonic saline in 0.5, 1, 2, 4 and 8minutes and during these times FEV1, PEF, FEF25-75 and FVC will be measured. The nebulization will be continued till a 15% decrease in FEV1or 20% decrease in PEF happens. In this condition value of hypertonic saline, spent time &changes in FEF25-75 and FVC would be inserted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104266187N2
Registration date:2011-07-18, 1390/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-18, 1390/04/27
Registrant information
Name
Mohammadi Saba
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
saba-ma@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of time and amount of hyper tonic saline required to induce a 15% FEV1decrease in asthmatic patients with FEV1>60% predicted
Public title
Determination of time and amount of hyper tonic saline required to induce a 15% FEV1 decrease in asthmatic patients referred to shahid beheshti hospita,l Kashan
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: asthmatic patients, age between 15 to 60 with FEV1>60%
Exclusion criteria: pneumonia; bronchectasia, advance interstitial lung disease; pulmonary fibrosis; chronic obstructive pulmonary disease and valvular & congenital heart disease.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
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
Kashan University of Medical Sciences
Street address
Ghotb ravandi boulvard km5
City
Kashan
Postal code
87159/88141
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
p29513532
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.8
ICD-10 code description
Mixed asthma
Primary outcomes
1
Description
15% decrease in FEV1
Timepoint
0.5 minute
Method of measurement
Spirometry
2
Description
15%decrease in FEV1
Timepoint
1 minute
Method of measurement
spirometry
3
Description
15% decrease in FEV1
Timepoint
2 minute
Method of measurement
spirometry
4
Description
15% decrease in FEV1
Timepoint
4 minute
Method of measurement
spirometry
5
Description
15% decrease in FEV1
Timepoint
6 minute
Method of measurement
spirometry
6
Description
15% decrease in FEV1
Timepoint
8 minute
Method of measurement
spirometry
Secondary outcomes
1
Description
20% decrease in PEF
Timepoint
0.5 minute
Method of measurement
spirometry
2
Description
20% decrease in PEF
Timepoint
1 minute
Method of measurement
spirometry
3
Description
20% decrease in PEF
Timepoint
2 minute
Method of measurement
spirometry
4
Description
20% decrease in PEF
Timepoint
4 minute
Method of measurement
spirometry
5
Description
20% decrease in PEF
Timepoint
6 minute
Method of measurement
spirometry
6
Description
20% decrease in PEF
Timepoint
8 minute
Method of measurement
spirometry
Intervention groups
1
Description
Intervention: The patients will be exposed to ultrasonic nebulizer with stable amount of nebulized hypertonic saline in 0.5, 1, 2, 4 and 8 minutes. The nebulization will be continued till a 15% decrease in FEV1or 20% decrease in PEF
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohammadali Saba
Street address
Km5 Ghotb Ravandi Blv
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medicine Sciences
Full name of responsible person
Dr Gholamreza Hamidi
Street address
km 5 Ghotb Ravandi Blv
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medicine 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
Kashan University of Medicine Sciences
Full name of responsible person
Dr. Mohammad ali saba
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Beheshti hospital, km5 ghotb ravandi blv
City
Kashan
Postal code
87159/81151
Phone
+98 36 1555 0026
Fax
+98 36 1555 8900
Email
saba-ma@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medicine Sciences
Full name of responsible person
Dr Mohammadali Saba
Position
Assisstant Professor
Other areas of specialty/work
Street address
Shahid Beheshti hospital km5 ghotb ravandi blv
City
Kashan
Postal code
87159/81151
Phone
+98 36 1555 0026
Fax
+98 36 1555 8900
Email
saba-ma@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)