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Study of the prevalence of aspirin sensitivity in patients with chronic rhinosinusitis and nasal polyposis coming to allergy department of Rasool-e-Akram hospital according to response to standard treatment after three months.

Protocol summary

Summary
objectives: study of the prevalence of aspirin sensitivity in patients with chronic rhinosinusitis and nasal polyposisaccording to response to standard treatment after three months. Study design: a phase 2, single center, non randomized, non placcebo controlled, non blinded, clinical trial. Methods: patients aging 18-65 years old with chronic rhinosinusitis and nasal polyposis undergo tretment with intranasal beclometasone twice a day, 10 miligram montelukast, 10 miligram cetirizin, 50 miligram prednisolone daily and nasal rinse, after paranasal sinuses computed tumography scan and SNOT questionnaire are completed. then aspirin challenge will be done. Inclusion criteria: age 18-65 years old; symptoms of chronic rhinosinusitis with nasal polyps which is documented on CT scan. Exclusion criteria: serious underlying disease such as bleedin tendency, gastrointestinal, rheumatologic, malignancy, cardiac, renal, hepatic, psychological; history of IgE mediated reactions to aspirin or nonsteroidal anti inflammatory drugs; first second expiratory volume of more than 70 percent of predicted before aspirin challenge test; pregnancy; breast feeding; use of topical and systemic beta blockers; use of warfarin; mastocytosis; patients with poor adherence. Sample size:100 patients. Interventions: single intervention group including intranasal beclometasone, daily montelukast, cetirizine, prednisolone and aspirin challenge after three months. Primary outcome: rhinosinusitis symptom severity. Secondary outcome: complications of treatment such as epistaxis, nasal burning, septal perforation, drowsiness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015061322531N1
Registration date: 2015-07-22, 1394/04/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-22, 1394/04/31
Registrant information
Name
Mohamad Nabavi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2383
Email address
nabavi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-23, 1394/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the prevalence of aspirin sensitivity in patients with chronic rhinosinusitis and nasal polyposis coming to allergy department of Rasool-e-Akram hospital according to response to standard treatment after three months.
Public title
Study of the prevalence of aspirin sensitivity in patients with chronic rhinosinusitis and nasal polyposis coming to allergy department of Rasool-e-Akram hospital according to response to standard treatment after three months.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 years old; presence of symptoms of chronic rhinosinusitis with nasal polyps which is documented on CT scan. Exclusion criteria: existence of any serious underlying disease such as bleedin tendency, gastrointestinal, rheumatologic, malignancy, cardiac, renal, hepatic, psychological; history of IgE mediated reactions to aspirin or nonsteroidal anti inflammatory drugs; first second expiratory volume of more than 70 percent of predicted before aspirin challenge test; pregnancy; breast feeding; use of topical and systemic beta blockers; use of warfarin and warfarin derivates; mastocytosis; patients with poor cooperation and poor adherence.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
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
Iran University of Medical Sciences
Street address
Fifth floor, Central Cental Building, Iran University of Medical Sciences, between Chamran and Sheikh Fazlollah highway, Hemmat Highway, Tehran.
City
Tehran
Postal code
Approval date
2015-04-18, 1394/01/29
Ethics committee reference number
105/228/د/94

Health conditions studied

1

Description of health condition studied
chronic rhinosinusitis with nasal polyposis
ICD-10 code
J33.8
ICD-10 code description
Other polyp of sinus Polyp of sinus: accessory ethmoidal maxillary sphenoidal

Primary outcomes

1

Description
severity of symptoms of chronic rhinosinusitis with nasal polyposis
Timepoint
after 3 months
Method of measurement
Sino Nasal Outcome Test (SNOT) questionnaire

Secondary outcomes

1

Description
complications of conventional treatment including epistaxis, nasal burning sensation, nasal septal perforation, feeling sleepy
Timepoint
before intervention, three months after intervention.
Method of measurement
history taking

Intervention groups

1

Description
one intervention group which includes conventional treatment for chronic rhinosinusitis with nasal polyposis including intranasal beclomethasone one puff in each nostril twice per day, nasal saline rinse with 5 mililiter of salin three times a day, 10 miligarm montelukast tablet once daily, 10 miligram cetirizine tablet once daily for three consecutive months and a 10 days course of prednisolone 50 milligrams per day, and aspirin challenge test after three months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Allergy department of rasool-e-akram hospital
Full name of responsible person
Sima Shokri
Street address
Fourth floor, Building number one, Rasool-e-Akram hospital, Niayesh street, Satrkhan Avenue,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vce chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Mousavi
Street address
Department of internal medicine, seventh floor, Rasool-e-akram ospital-Niayesh street-Sattarkhan avenue.
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vce chancellor for research of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sima Shokri
Position
Allergy and clinical immunology fellow
Other areas of specialty/work
Street address
Allergy department, Fourth floor, Building number one, Rasool-e-Akram hospital, Niayesh street, Satarkhan avenue
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2383
Fax
Email
dr.shokri.83@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamad Nabavi
Position
Associated professor
Other areas of specialty/work
Street address
Allergy department, Fourth floor, Building number one, Rasool-e-Akram hospital, Niayesh street, Satarkhan avenue
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2383
Fax
+98 21 6655 4933
Email
nabavi.m@iums.ac.ir; mnabavi44@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sima Shokri
Position
Allergy and clinical immunology fellow
Other areas of specialty/work
Street address
Allergy department, Fourth floor, Building number one, Rasool-e-Akram hospital, Niayesh street, Satarkhan avenue
City
Tehran
Postal code
Phone
+98 21 6435 2383
Fax
+98 21 6655 4933
Email
dr.shokri.83@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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