NCT01867281

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

May 29, 2013

Last Update Submit

June 28, 2014

Conditions

Asthma, Aspirin-Induced

Keywords

aspirinasthmaAspirin desensitizationAspirin induced asthmaImmune System DiseasesRespiratory Hypersensitivity

Outcome Measures

Primary Outcomes (4)

  • Change in SNOT-22 scores from Baseline

    At baseline and 6 months after treatment, all participants will complete the SNOT-22 questionnaire. SNOT-22 is a validated disease specific questionnaire that assesses the health related quality of life patients.

    6 months

  • change in serum concentration of IL-10

    At baseline and 6 months after treatment, serum level of IL-10 will be investigated for all participants.

    6 months

  • change in concentration of serum TGF-beta

    At baseline and 6 months after treatment, serum level of TGF-beta will be investigated for all participants

    6 months

  • change in concentration of serum IFN-gamma

    At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.

    6 months

Secondary Outcomes (4)

  • Lund Mackay score

    6 months

  • Asthma attacks

    6 months

  • medication needs

    6 months

  • FEV1

    6 months

Study Arms (2)

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.

Drug: aspirin

Control: placebo

PLACEBO COMPARATOR

Participants will receive placebo

Interventions

aspirinDRUG
Intervention: Aspirin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Related Publications (8)

  • Katial RK, Strand M, Prasertsuntarasai T, Leung R, Zheng W, Alam R. The effect of aspirin desensitization on novel biomarkers in aspirin-exacerbated respiratory diseases. J Allergy Clin Immunol. 2010 Oct;126(4):738-44. doi: 10.1016/j.jaci.2010.06.036. Epub 2010 Aug 21.

    PMID: 20728206BACKGROUND

  • White AA, Stevenson DD. Does suppression of IL-4 synthesis by aspirin explain the therapeutic benefit of aspirin desensitization treatment? J Allergy Clin Immunol. 2010 Oct;126(4):745-6. doi: 10.1016/j.jaci.2010.08.037. No abstract available.

    PMID: 20920763BACKGROUND

  • Rozsasi A, Polzehl D, Deutschle T, Smith E, Wiesmiller K, Riechelmann H, Keck T. Long-term treatment with aspirin desensitization: a prospective clinical trial comparing 100 and 300 mg aspirin daily. Allergy. 2008 Sep;63(9):1228-34. doi: 10.1111/j.1398-9995.2008.01658.x.

    PMID: 18699939BACKGROUND

  • Menzies D, Nair A, Meldrum KT, Hopkinson P, Lipworth BJ. Effect of aspirin on airway inflammation and pulmonary function in patients with persistent asthma. J Allergy Clin Immunol. 2008 May;121(5):1184-1189.e4. doi: 10.1016/j.jaci.2008.01.009. Epub 2008 Mar 4.

    PMID: 18313127BACKGROUND

  • Swierczynska M, Nizankowska-Mogilnicka E, Zarychta J, Gielicz A, Szczeklik A. Nasal versus bronchial and nasal response to oral aspirin challenge: Clinical and biochemical differences between patients with aspirin-induced asthma/rhinitis. J Allergy Clin Immunol. 2003 Nov;112(5):995-1001. doi: 10.1016/s0091-6749(03)02015-3.

    PMID: 14610494BACKGROUND

  • Vaidyanathan S, Williamson PA, Lipworth BJ. Is a positive nasal lysine-aspirin challenge test associated with a more severe phenotype of chronic rhinosinusitis and asthma? Am J Rhinol Allergy. 2012 May-Jun;26(3):e89-93. doi: 10.2500/ajra.2012.26.3767.

    PMID: 22643934BACKGROUND

  • Higashi N, Taniguchi M, Mita H, Yamaguchi H, Ono E, Akiyama K. Aspirin-intolerant asthma (AIA) assessment using the urinary biomarkers, leukotriene E4 (LTE4) and prostaglandin D2 (PGD2) metabolites. Allergol Int. 2012 Sep;61(3):393-403. doi: 10.2332/allergolint.11-RA-0403. Epub 2012 May 25.

    PMID: 22627848BACKGROUND

  • Chang JE, White A, Simon RA, Stevenson DD. Aspirin-exacerbated respiratory disease: burden of disease. Allergy Asthma Proc. 2012 Mar-Apr;33(2):117-21. doi: 10.2500/aap.2012.33.3541.

    PMID: 22525387BACKGROUND

MeSH Terms

Conditions

Asthma, Aspirin-InducedAsthmaImmune System DiseasesRespiratory Hypersensitivity

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesHypersensitivity, ImmediateHypersensitivityDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Hossein Esmaeilzadeh, MD

    Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.

    STUDY DIRECTOR

  • Mohammad Nabavi, MD

    Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.

    STUDY CHAIR

  • Zahra Aryan, MD, MPH, student

    Molecular Immunology Research Center, Tehran University of Medical Sciences.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

IR(1)