The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Asthma, Aspirin-Induced

Treatments: Drug: aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01867281

92-01-119-20728

Details and patient eligibility

About

The purpose of this study is to determine the effect of aspirin desensitization on symptoms and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).

Enrollment: 32 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with clinical diagnose of aspirin-exacerbated respiratory disease
• History of physician diagnosed asthma.
• History of physiacian diagnosed chronic rhinosinositis with nasal polyps.
• Positive reaction to aspirin challenge test.
• Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).

Exclusion criteria

• Being smoker
• pregnancy
• Current breastfeeding
• History of bleeding diathesis
• History of transient ischemic attack or stroke, or diabetes.
• History of abnormal hepatic function
• Uncontrolled hypertension or use of beta blocker medication.
• History of gastrointestinal ulcers or gastrointestinal bleeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Intervention: Aspirin

Active Comparator group

Description:

Participants will undergo aspirin desensitization over a 2-day period with increasing doses of aspirin (60, 125, 325 and 625 mg). Thereafter,they will be followed with 625 mg aspirin bid.

Treatment:

Drug: aspirin

Control: placebo

Placebo Comparator group

Description:

Participants will receive placebo