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The effect of aspirin in treatment of moderate to severe aspirin-sensitive asthmatic patients

Clinical trial comparing the effects of low dose aspirin and placebo on clinical improvement of moderate to severe aspirin-sensitive asthmatic patients with chronic rhinosinusitis and nasal polyposis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015061521970N2
Enrollment
30
Registered
2015-07-27
Start date
2015-07-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Asthma. Condition 2: Chronic rhinosinusitis. Condition 3: Nasal polyposis. Mixed asthma Combination of conditions listed in J45.0 and J45.1 J32 (abscess empyema infection suppuration) (chronic) of sinus (accessory)(nasal) Nasal polyposis

Interventions

Intervention 1: Intervention group: tab aspirin 100 mg, daily for 6 months. Intervention 2: Intervention group:tab aspirin 325 mg, daily for 6 months. Intervention 3: Control group: placebo, daily for
Treatment - Drugs
Placebo
Intervention group: tab aspirin 100 mg, daily for 6 months
Intervention group:tab aspirin 325 mg, daily for 6 months
Control group: placebo, daily for 6 months

Sponsors

Vice chancellor for research, Iran Uiversity of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 18 to 65 years old; clinical symptoms of chronic rhinosinusitis with nasal polyposis which confirmed by sinus CT scan; moderate to severe asthma according to the history, spirometric findings and Expert Panel Report 3 (EPR-3) guidelines; receiving the full course of standard treatments for rhinosinusitis and asthma according to the EPR-3 guidelines for 3 months before entering study Exclusion criteria: presence of serious underlying disease such as bleeding disorders, gastrointestinal, rheumatologic, cancer, heart, kidney, liver and mental diseases; medical history of immediate hypersensitivity reactions to aspirin and nonsteroidal anti-inflammatory drugs; Forced Expiratory Volume in the first second (FEV1) less than 70% at the time of aspirin challenge; pregnancy; breast-feeding; the use of systemic and topical beta-blocker, angiotensin-converting enzyme inhibitor, angiotensinogen ? receptor blocker, warfarin; mastocytosis; nonadherent patients; patients with high risk jobs or lifestyle

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Asthma symptoms. Timepoint: After 3 and 6 months. Method of measurement: Standard questionnaire "Asthma Control Test".;Pulmonary function. Timepoint: After 3 and 6 months. Method of measurement: Spirometry test.

Secondary

MeasureTime frame
Aspirin side effect: bleeding. Timepoint: Monthly. Method of measurement: Questionnaire.;Aspirin side effect: gastrointestinal disturbance. Timepoint: Monthly. Method of measurement: Questionnaire.;Asthma standard treatment side effect: hoarseness. Timepoint: Monthly. Method of measurement: Questionnaire.;Asthma standard treatment side effect: mouth thrush. Timepoint: Monthly. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Narges Eslami

Allergy and clinical immunology department of Rasool Akram hospital

drnarges@yahoo.com+98 21 6435 2383

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 15, 2026