(1) Objectives:This study is assign to investigate efficacy of aspirin desensitization in chronic rhinosinusitis with nasal polyposis patients who have aspirin sensitive asthma.
(2) Design (study groups and phase, sample size, blinding, randomization, single or multi center): Nasal polyposis patients that have aspirin sensitivity in aspirin challenge test will be divided into case and control groups, seventeen in each group by third person with previous blindly randomized blocked groups setting.This is a multi central double blind study.
(3) Setting and conduct: Nasal polyposis patients with aspirin sensitivity in case group will desensetize with aspirin in 2 days and receive aspirin in one month and patients in control group receive placebo. Outcome variables will be compare at the end of month one.
(4) Participants including major eligibility criteria: inclusion criteria is chronic rhinosinusitis with nasal polyposis and exclusion criteria include: gasterointestinal or hematologic problem; pregnancy and immediate reactions to analgesics.
(5) Intervention: Aspirin challenge test; Aspirin desensitization; Placebo in control group
(6) main outcome measures: primary outcomes are quality of life and spirometry and secondary outcome variables are interleukine 4 and 5.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070728821N1
Registration date:2016-08-24, 1395/06/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
negar mortazavi mehdiabad
Name of organization / entity
school of pharmacy, shahid beheshti universty of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 2904
Email address
n.mortazavi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid beheshti University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and biochemical Aspirin desensitization effectiveness assay in patients with nasal polyposis and aspirin sensitive asthma
Public title
Efficacy of aspirin desensitization in nasal polyposis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic rhinosinusitis (CRS) with nasal polyposis patients more than 18 years old that is admitted in allergy clinic. CRS diagnose criteria:(1) 2 or more of symptoms: nasal congestion; pain or pressure of face; post or anterior discharge; loss of smell. (2) Symptoms should stay more than 12 week. CRS with nasal polyposis diagnose will confirm by CT SCAN or endoscopy of sinus.
Exclusion criteria: Forced expiratory volume at first second less than 70% in spirometry; gastrointestinal bleeding; pregnancy or breast feeding; Anaphylaxy to Nonsteroidal anti inflammatory drugs (NSAID); Myocardial infarction or stroke in last 6 month and sever liver or kidney disease.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Blocking
Secondary Ids
1
Registry name
No
Secondary trial Id
No
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
vali asr Ave, niayesh St, Pharmacy college, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.SBMU.PHNM.1394.296
Health conditions studied
1
Description of health condition studied
nasal polyp
ICD-10 code
j33.0
ICD-10 code description
Polyp of nasal cavity
Primary outcomes
1
Description
Quality of life
Timepoint
Before and one month after intervention
Method of measurement
Questiner
2
Description
Respiratory function
Timepoint
Before and one month after intervention
Method of measurement
Spirometry
Secondary outcomes
1
Description
Interleukin 4
Timepoint
Before and onemonth after intervention
Method of measurement
Quantitative pg/ml
2
Description
Interleukin 5
Timepoint
Before and onemonth after intervention
Method of measurement
Quantitative pg/ml
Intervention groups
1
Description
Intervention group : Aspirin sensitive nasal polyposis patients will recieve 2 days desensitization protocol in case group, that will be done by Ketrolac nasal drop (1 and 2 drop in each canal with 30 minute interval) and after that 40 and 60 mg aspirin feeding in day one and 80,160 and 325 mg aspirin in day 2, all with 90 minute interval. After desensitization 650 mg aspirin per day start in first month.
Category
Treatment - Drugs
2
Description
Control group: Aspirin sensitive patients in control group receive starch tablet instead of aspirin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hospital
Full name of responsible person
Negar Mortazavi Mehdiabad- Resident of Clinical Pharmacy
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Emam reza clinic
Full name of responsible person
negar mortazavi mehdiabad- resident of clinical pharmacy
Street address
Emam reza clinic, Zand Street, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Aarabi Ave, Yaman Street, Chamran Highway, Shahid Beheshti University of Medical University
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, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences; School of Pharmacy