Objective: Prevalence of aspirin sensitivity in patients with moderate to severe asthma according to the response to 3 months asthma standard therapy.
Design: Single arm study, not blinded, placebo not used, single center.
Major Inclusion criteria: Patients 18 to 65 years old with moderate to severe asthma based on history, spirometric findings and Expert Panel Report 3 (EPR-3) guidelines.
Major Exclusion criteria: Patients with serious underlying disease; medical history of immediate hypersensitivity reactions to aspirin and nonsteroidal anti-inflammatory drugs; Forced Expiratory Volume in the first second (FEV1) less than 70% at the time of aspirin challenge; pregnancy; breast-feeding; using of medication interfering with the aspirin challenge.
Sample size: 100 patients.
Intervention: Patients are treated with asthma standard treatment for 3 months according to the EPR-3 guidelines including inhaled corticosteroids and inhaled long-acting bronchodilators (fluticasone-salmeterol 250/50 microgram) and if necessary montelukast or oral corticosteroids (prednisolone) and treatment of comorbidities such as gastroesophageal reflux disease and rhinosinusitis if required.
Main outcome measures: Evaluation of asthma symptoms according to standard questionnaire ACT (Asthma Control Test), pulmonary function based on spirometry test and monitored for treatment side effect according to questionnaire are performed at first and after 3 months of study. At the end of 3 months, after obtaining informed consent, aspirin challenges are performed for them and the prevalence of aspirin sensitivity in moderate to severe asthma are evaluated according to the asthma control (based on ACT score and spirometric findings) after 3 months of asthma standard therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042721970N1
Registration date:2015-07-29, 1394/05/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-29, 1394/05/07
Registrant information
Name
Saba Arshi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2383
Email address
arshi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran Uiversity of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevalence of aspirin sensitivity in patients with moderate to severe asthma according to the response to 3 months asthma standard therapy
Public title
Prevalence of aspirin sensitivity in moderate to severe asthma according to the response to 3 months asthma standard therapy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 65 years old; moderate to severe asthma according to the history and spirometric findings and EPR-3 (Expert Panel Report 3) guidelines
Exclusion criteria: Presence of serious underlying disease such as bleeding disorders, gastrointestinal, rheumatologic, cancer, heart, kidney, liver and mental diseases; medical history of immediate hypersensitivity reactions to aspirin and nonsteroidal anti-inflammatory drugs; Forced Expiratory Volume in the first second (FEV1) less than 70% at the time of aspirin challenge; pregnancy; breast-feeding; the use of systemic and topical beta-blocker, angiotensin-converting enzyme inhibitor, angiotensinogen ǁ receptor blocker, warfarin; mastocytosis; nonadherent patients; patients with high risk jobs or lifestyle
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Iran University of Medical Sciences
Street address
Iran University of Medical Science, Hemmat highway, Tehran
City
Tehran
Postal code
Approval date
2015-04-18, 1394/01/29
Ethics committee reference number
105/227/د/94
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.8
ICD-10 code description
Mixed asthma Combination of conditions listed in J45.0 and J45.1
Primary outcomes
1
Description
Asthma symptoms
Timepoint
At first and after 3 months of study
Method of measurement
Standard questionnaire "Asthma Control Test"
2
Description
Pulmonary function
Timepoint
At first and after 3 months of study
Method of measurement
Spirometry test
Secondary outcomes
1
Description
Asthma standard treatment side effect: mouth thrush
Timepoint
Monthly
Method of measurement
Questionair
2
Description
Asthma standard treatment side effect: hoarseness
Timepoint
Monthly
Method of measurement
Questionnaire
Intervention groups
1
Description
Standard treatment of moderate to severe asthma based on EPR-3 guidelines, include inhaled corticosteroids, inhaled long acting bronchodilators(for moderate asthma: Fluticasone-Salmeterol 250/50 microgram oral inhaler (Salmeflo “SADAF DAROU SABA”) 1 puff every 12 hours and for severe asthma: Fluticasone-Salmeterol 250/50 microgram oral inhaler (Salmeflo “SADAF DAROU SABA”) 2 puff every 12 hours) and if necessary montelukast 10 mg (Abidi) daily or oral corticosteroids (prednisolone) and treatment of comorbidities such as gastroesophageal reflux disease and rhinosinusitis if required.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy and clinical immunology department of Rasool Akram hospital
Full name of responsible person
Dr Narges Eslami, fellowship of allergy and clinical immunology
Street address
Allergy and clinical immunology department, Rasool Akram hospital, Niyayesh avenue, Sattarkhan street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran Uiversity of Medical Sciences
Full name of responsible person
Dr Seyyed Ali Javad Mosavi, Deputy of Research and Technology
Street address
Iran University of Medical Science, Hemmat highway, 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, Iran Uiversity 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
Allergy and clinical immunology department of Rasool Akram hospital
Full name of responsible person
Dr Narges Eslami
Position
Fellowship of Allergy and clinical immunology
Other areas of specialty/work
Street address
Tehran, Sattarkhan street, Niyayesh avenue, Rasool Akram hospital, Allergy and clinical immunology department
City
Tehran
Postal code
Phone
+98 21 6435 2383
Fax
Email
drnarges@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allergy and Clinical Immunology department of Rasool Akram hospital
Full name of responsible person
Dr Saba Arshi
Position
Head of Allergy and Clinical Immunology department
Other areas of specialty/work
Street address
Allergy and clinical immunology department, Rasool Akram hospital, Niyayesh avenue, Sattarkhan street, Tehran
City
Tehran
Postal code
Phone
+98 21 6435 2383
Fax
Email
arshi.s@iumc.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Allergy and clinical immunology department of Rasool Akram hospital
Full name of responsible person
Dr Narges Eslami
Position
Fellowship of allergy and clinical Immunology
Other areas of specialty/work
Street address
Allergy and clinical immunology department, Rasool Akram hospital, Niyayesh avenue, Sattarkhan street, Tehran
City
Tehran
Postal code
Phone
+98 21 6435 2383
Fax
Email
drnarges@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)