Asthma controlled patients by steroid inhaler and Montelucast will be recruited from Imam Khomeini pulmonary clinic. All patients enrolled in this study after explaining study goals and methods and getting their informed consent . Their demographic data and all past medical history will be recorded in designed forms. Patients will be randomized by four block randomization methods in A and B groups. In A group steroid inhaler dose will be halved and other medications will be continued. In B group Montelucast will be discontinued and steroid inhaler and other medications will be continued. All patients will be visited in the pulmonary clinic at months 1 and 3 and ACT questionnaire and spirometry will be done in each visit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052428037N1
Registration date:2016-07-01, 1395/04/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Hamidreza Abtahi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2646
Email address
hrabtahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr.Abidi Pharmaceutical Compani
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Reduction of steroid inhaler dose in comparison with Montelucast discontinuation in asthma patients controlled by steroid inhaler and Montelucast
Public title
Comparison of two methods of asthma medication reduction in patients with controlled asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1: Asthmatic patients with Asthma Control Test (ACT) >20 and FEV1> 80% predicted in two sequential visits
2: Age >18 years old
3.Asthma symptoms>1 year
4: Use of asthma controller medications >3 months
5: At least 2 monthly visits by his/her physician in Imam Khomeini pulmonary clinic
Exclusion Criteria:
1: Use of systemic steroids or emergency visit in the past 3 months due to asthma exacerbation
2: Pregnancy
3: Inability or unwillingness for scheduled visits by his/her physician
4: Patients request for increase in the asthma medication after enrolling in this study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Univecityof Medical Science
Street address
Tehran Univecityof Medical Science
City
Tehran
Postal code
Approval date
2016-05-15, 1395/02/26
Ethics committee reference number
94-03-159-30560
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthma control Rate
Timepoint
3 months
Method of measurement
Asthma Control Tool and Espirometry
Secondary outcomes
1
Description
Exacerbation numbers
Timepoint
during study
Method of measurement
Emergency visit due to exacerbation
Intervention groups
1
Description
In A group steroid inhaler dose will be halved and other medication will be continued
Category
Treatment - Drugs
2
Description
In B group Montelucast will be discontinued and steroid inhaler and other medication will be continued
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini pulmonary clinic
Full name of responsible person
Dr. Rahimi
Street address
Imam Khomeini pulmonary clinic
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr.Abidi Pharmaceutical Company
Full name of responsible person
Amir Razavian
Street address
Dr.Abidi Pharmaceutical Company
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr.Abidi Pharmaceutical Company
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
Full name of responsible person
Hamidreza Abtahi
Position
Pulmonologist
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2645
Fax
Email
hrabtahi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Hamidreza Abtahi
Position
Pulmonologist
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2645
Fax
Email
hrabtahi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Hamidreza Abtahi
Position
Pulmonologist
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2645
Fax
Email
hrabtahi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)