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S?tudy of the theraputic effect of low dose aspirin on symptoms of chronic rhinosinusitis and nasal polyposis with aspirin sensitivity

Phase 2
Conditions
Chronic rhinosinusitis with nasal polyposis.
Other polyp of sinus Polyp of sinus: accessory ethmoidal maxillary sphenoida
Registration Number
IRCT2015061522531N2
Lead Sponsor
Vice chancellor for research, Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

age of 18-65 years; achieving a course of three months of conventional treatment before aspirin challenge; presence of symptoms of chronic rhinosinusitis with nasal polyposis confirmed by CT scan;
Exclusion criteria: presence of any serious underlying disease including hemorrhagic; gastrointestinal; rheumatologic; malignant; cardiovascular; renal; hepatic and psychological disorders; history of IgE mediated reactions to aspirin or other non steroidal anti inflammatory drugs; first second expiratory volume of less than 70 percent of predicted at the time of aspirin challenge; pregnancy; nursing; use of topical or systemic beta blockers; warfarin and its derivates; Angiotensin converting enzyme inhibitors; patients with poor cooperation or treatment adherence; patients with carriers with high risk of trauma and accidents;

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of symptoms of chronic rhinosinusitis with nasal polyposis. Timepoint: before intervention, three months and six minths after intervention. Method of measurement: SinoNasal Outcome Test questionnaire and paranasa sinus CT scan.
Secondary Outcome Measures
NameTimeMethod
Complications of aspirin including gastrointestinal dyscomfort, epigastric pain or burning, nausea, vomitting, gastro intestinal bleeding, easy bruising, bleeding with minor trauma. Timepoint: before intervention, three and six months after intervention. Method of measurement: history taking and physical examination.
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