Trial | NCT01867281  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    32
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).
Study Started
Jun 30
2013
Primary Completion
Jun 30
2014
Study Completion
Jun 30
2014
Last Update
Jul 01
2014
Estimate

Drug aspirin

Intervention: Aspirin Active Comparator

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.

Control: placebo Placebo Comparator

Participants will receive placebo

Criteria 

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.
No Results Posted