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comparison of frequency of aspirin hypersensitivity in people with and without nasal polyps

Protocol summary

Summary
We want to compare the frequency of aspirin hypersensitivity in people with and without nasal polyps. in this study, we select 2 group of people in range of 18-60 years old. The first group is patients who referred to ENT service in Rasht, Amiralmomenin hospital and diagnosis of nasal polyps is definite for them by endoscopy or CTs, and the second group select from healthy people (without the nasal polyps). The size of the samples is 48 in each group.In both group oral aspirin challenge test is done.Those with contraindications for oral aspirin challenge test (a history of very severe anaphylactic reaction,severe disease of the heart, digestive tract, liver and kidney, infection of respiratory tract within 4weeks prior to the challenges, pregnancy and current treatment with beta receptor blocker)were left out of the study.After the ensurance that the patient is in a stable clinical condition(by spirometery), oral aspirin challenge test is done in 2 Consecutively days.in every day 3 increasing doses of aspirin(20-40-80 & 120-160-325) will be given to the patient and the patient's clinical symptoms check.On the basis of the clinical symptoms (Naso-ocular alone/Naso-ocular and a 15% or > decline in FEV1 (Classic reaction)/ Lower respiratory reaction only (FEV1 declines by >20%)/Laryngospasm with or without a, b, c /Systemic reaction: hives, flush, gastric pain, hypotension) test result will be positive or negative.

General information

Acronym
ENT-HNS
IRCT registration information
IRCT registration number: IRCT201408191138N12
Registration date: 2014-09-17, 1393/06/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-09-17, 1393/06/26
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences,Vice Chancellor for Research
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of frequency of aspirin hypersensitivity in people with and without nasal polyps
Public title
aspirin hypersensitivity
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:All patients with nasal polyps that including male and female and in range of 18-60 years old who referred to ENT service in Rasht, Amiralmomenin hospital and diagnosis of nasal polyps is definite for them by endoscopy or CTs if don't have contraindications for oral aspirin challenge test inclusion to our study. Those with contraindications for oral aspirin challenge test were left out of the study : 1-a history of very severe anaphylactic reaction, 2-severe disease of the heart, digestive tract, liver and kidney, 3- infection of respiratory tract within 4weeks prior to the challenges, 4- pregnancy, 5- current treatment with beta receptor blocker. Control group is healthy people that don't have nasal polyps and contraindications for oral aspirin challenge test. Exclusion criteria:If the result of test is positive.
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: 96
Randomization (investigator's opinion)
Not randomized
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
Guilan University of medical sciences
Street address
Shahid Beheshti BL.
City
Rasht
Postal code
Approval date
2014-05-02, 1393/02/12
Ethics committee reference number
19300775302

Health conditions studied

1

Description of health condition studied
Nasal polyp
ICD-10 code
J33
ICD-10 code description
Nasal polyp

Primary outcomes

1

Description
Nasoocular symptoms alone
Timepoint
every 1 hour to 3 h after each dose of aspirin
Method of measurement
clinical inspection

2

Description
Nasoocular symptoms and a 15% or greater decline in FEV(classic reaction)
Timepoint
every 1 hour to 3 h after each dose of aspirin
Method of measurement
clinical inspection and physical exam

3

Description
Lower respiratory reaction only (FEV1 declines by >20%)
Timepoint
every 1 hour to 3 h after each dose of aspirin
Method of measurement
clinical inspection and physical exam

4

Description
Laryngospasm with or without any of the first 3 reactions
Timepoint
every 1 hour to 3 h after each dose of aspirin
Method of measurement
clinical inspection and physical exam

5

Description
Systemic reactions: hives, flushing, gastric pain, hypotension
Timepoint
every 1 hour to 3 h after each dose of aspirin
Method of measurement
clinical inspection and physical exam

Secondary outcomes

empty

Intervention groups

1

Description
In both group oral aspirin challenge test is done. On the first day,aspirin with exponentially increasing doses (20,40,80mg),are administered at 3-hour intervals and On the second day,aspirin with exponentially increasing doses (120,160,325mg),are administered at 3-hour intervals.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Shadman Nemati
Street address
Amiralmomenin Hospital
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences,Vice Chancellor for Research
Full name of responsible person
Susan Komaii
Street address
Siadati st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences,Vice Chancellor for Research
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital,17 shahrivar st
City
Rasht
Postal code
4139637459
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital,17 shahrivar st.
City
Rasht
Postal code
4139637459
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address

Person responsible for updating data

Contact

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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