1.Objectives: Evaluation of subjective response, using a course of empiric treatment in clinically suspected asthma despite negative paraclinic tests . 2.Design: Patients with high clinical probability of asthma despite negative methacholine test will receive a trial of treatment for assessing before and after subjective response. This also may be a diagnostic mean for confirming asthma. 3.Setting and conduct: after 2 weeks run in period, patients will be treated with 12 weeks course of inhaled Fluticasone. 4.Participants including major eligibility criteria: Patients with mild to moderate persistent complaints, that are highly suggestive of asthma,will be included in this study. Those with history and physical examination or imaging compatible with other diagnosis or environmental toxic exposure will be excluded from study. 5.Intervention: Flixotide (gsk, Australia) in metered dose inhaler (MDI) with dose of 250 µg 2 puff BID for 12 weeks 6.Main outcome measures variables: evaluating before and after treatment subjective response with “Asthma Control Test” and “numeric cough score”.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202297795N1
Registration date:2012-03-23, 1391/01/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-23, 1391/01/04
Registrant information
Name
Soheil Peiman
Name of organization / entity
Tehran University of Medical Science, Imam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 2450
Email address
s-peiman@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-02-15, 1390/11/26
Expected recruitment end date
2012-05-01, 1391/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Subjective response to inhaled steroid in patients with clinically suspected asthma and negative methacholine challenge test
Public title
Asthma treatment in patients with negative Methacholine test
Purpose
Diagnostic
Inclusion/Exclusion criteria
Study inclusion criteria :
1. high clinical probability of asthma;
2.Normal chest-x-ray;
3.Normal spirometry;
4.Negative methacholine challenge test;
5.Symptoms for at least 2 month;
6.Those who complete treatment course and follow up;
Study Exclusion criteria:
1.Low clinical probability of asthma;
2.Abnormality in imaging and spirometry;
3.More than 20 pack year smoking;
4.Prominent medical disease;
5.Significant occupational injury;
6.Those who do not complete treatment course and follow up;
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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 of Tehran university of medical sciences
Street address
6th floor, central organization of Tehran university of medical sciences, ghods street,
City
Tehran
Postal code
Approval date
2012-02-15, 1390/11/26
Ethics committee reference number
130/2251
Health conditions studied
1
Description of health condition studied
Asthma/Airway hyperactivity symptoms
ICD-10 code
J45.8
ICD-10 code description
Combination of Nonallergic asthma and allergic asthma
Primary outcomes
1
Description
Asthma Control Test questionnaire Score
Timepoint
12 weeks
Method of measurement
questionnaire
2
Description
Numeric Cough Score
Timepoint
12 weeks
Method of measurement
questionnaire
Secondary outcomes
1
Description
General satisfaction of patients
Timepoint
after 12 weeks
Method of measurement
ACT questionnaire (question number 5) score
Intervention groups
1
Description
12 weeks course of inhaled Fluticasone (Flixotide®-GlaxoSmithKline Australia) in metered dose inhaler (MDI) with dose of 250 µg 2 puff BID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Respirstory clinic
Full name of responsible person
Street address
Noor Day clinic, Motahhari street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Tehran University of Medical Sciences
Street address
Floor 4, Central organization of Tehran university of medical sciences, Ghods street, Keshavaez blv, Tehran
City
Tehran
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, Tehran 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
Tehran university of medical science, Imamkhomeini medical center
Full name of responsible person
Dr. Soheil Peiman
Position
MD, Internal medicine Resident
Other areas of specialty/work
Street address
Internal medicine education office, Imamkhomeini medical center, Keshavarz blv, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1639
Fax
Email
s-peiman@razi.tums.ac.ir; soheil_peiman@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical science, Imamkhomeini medical center, Pulmonary disease division
Full name of responsible person
Dr. HamidReza Abtahi
Position
Assistant professor
Other areas of specialty/work
Street address
Respiratory reasearch center, Imamkhomeini hospital, Keshavarz blv, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1639
Fax
Email
hrabtahi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical science, Imamkhomeini medical center
Full name of responsible person
Dr. Soheil Peiman
Position
MD, Internal medicine resident
Other areas of specialty/work
Street address
Internal medicine education office, Imamkhomeini medical center, Keshavarz blv, Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1639
Fax
Email
soheil_peiman@yahoo.com; s-peiman@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)