Title: Comparison of the efficacy and safety of Salmeflo and Seretide in patients with asthma, Objectives: Review clinical efficacy, adverse effects and patients satisfacation of Salmeflo compared to Seretide, Design: Controlled clinical trial,Blinding: Single blind , Inclusion criteria: Patients aged 18 years and older who are willing to participate and sign a consent form; Patients who have the ability of using the inhaler with correct technique;
exclusion criteria: Using of Inhaled Corticosteroid or Long Acting Beta Agonist in the last month before entering the study; patients with known hypersensitivity to Beta 2 agonist or Inhaled Corticosteroid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083014727N5
Registration date:2014-12-23, 1393/10/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-23, 1393/10/02
Registrant information
Name
Fanak Fahimi
Name of organization / entity
Shahid Behesti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 0939
Email address
fahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Sadaf Darou Saba Company
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of Salmeflo and Seretide in patients with asthma
Public title
Clinical safety and efficacy study in asthmatic patients who use Salmeflo Inhaler
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 18 years and older who are willing to participate and sign a consent form; Patients who have the ability of using the inhaler with correct technique;
exclusion criteria: Using of Inhaled Corticosteroid or Long Acting Beta Agonist in the last month before entering the study; patients with known hypersensitivity to Beta 2 agonist or Inhaled Corticosteroid; patients with lower respiratory system's infection (abnormal chest X ray) during the study; Alcoholics, drugs abuser; Patients who are pregnant or breastfeeding; Patients who use drug for another asthma trial; Patients with another severe and uncontrolled chronic disease, such as Heart failure, FC III, IV and history of myocardial infarction; Patients who show symptoms of acute reactions during the study; Non-compliance patient with treatment protocols; Requiring to use oxygen or systemic corticosteroid during the study; Disability to record the use of rescue medication accurately.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Use the table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Behesti University of Medical Sciences
Street address
Next to Taleghani Hospital, A'rabi St., Yaman St., Chamran highway
City
Tehran
Postal code
Approval date
2014-09-14, 1393/06/23
Ethics committee reference number
0308/10827
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45 , J46
ICD-10 code description
Asthma , Status asthmaticus
Primary outcomes
1
Description
Comparison of averages of FEV1
Timepoint
Before study, Every 4 weeks after study
Method of measurement
by Spirometry
2
Description
comparision of disease management
Timepoint
Before Study, Every 4 weeks after study
Method of measurement
ACT query
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Salmeflo 125/25 , 2 puffs BID
Category
Treatment - Drugs
2
Description
Control group: Seretide 125/25, 2 puffs BID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Dr Jalal Heshmat Nia
Street address
Shahid beheshti Street , Valiasr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sadaf Darou Saba Company
Full name of responsible person
Niloofar Shamsolketabi
Street address
No 19, Tirdad Alley, Aliakbari St., Motahari St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?