NCT01681615

Brief Summary

The investigators want to find new challenge test for Acetylsalicylic hypersensitivity / Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient as the already established protocols in terms of sensitivity and specificity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
unknown

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

August 9, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

August 9, 2012

Last Update Submit

September 12, 2012

Conditions

Asthma Aspirin-sensitiveASA Intolerant AsthmaAsthma, Aspirin-InducedAsthma, Nasal Polyps, and Aspirin Intolerance

Keywords

Challenge test for Aspirin HypersensitivityChallenge test for Acetylsalicylic Hypersensitivity

Outcome Measures

Primary Outcomes (3)

  • Inspiratory nasal flow measured by Rhinomanometry

    Bilateral flow reduction \>40% considered positive test.

    Within 45 min from challenge

  • Expiratory nasal flow measured by Rhinomanometry

    Bilateral expiratory flow reduction \>40% considered positive.

    Within 45 min from challenge

  • Pulmonary forced expiratory volume in 1 second (FEV1)

    Reduction in FEV1 \>20% is considered as positive test.

    Within 45 min from challenge

Secondary Outcomes (3)

  • Conjunctival symptoms

    Within 45 days from challenge

  • Nasal symptoms

    Within 45 minutes from challenge

  • Bronchial and laryngeal symptoms

    Within 45 minutes from challenge

Other Outcomes (1)

  • Other significant and relevant symptoms

    Within 45 days after challenge

Study Arms (2)

Acetylsalicylate

ACTIVE COMPARATOR

Acetylsalicylic Acid Eyedrops

Drug: Acetylsalicylate

isotonic NaCl

PLACEBO COMPARATOR

Saline Eyedrops

Drug: Isotonic NaCl

Interventions

AcetylsalicylateDRUG

1-2 drops

Acetylsalicylate
Isotonic NaClDRUG

1 drop

isotonic NaCl

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Persons between 18 and 60 years of age
  • Suspected Acetylsalicylic Acid Hypersensitivity

You may not qualify if:

  • History on anaphylactic shock after NSAIDS intake
  • History on gastric ulcer after NSAIDS intake
  • Patients previously gone through testing or desensitisation for Aspirin hypersensitivity
  • Clinical unstable asthma or baseline FEV1\<70%
  • Severe disease of the heart, digestive tract, liver or kidney
  • Severe chronic urticaria
  • Present conjunctivitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

Location

Related Publications (25)

  • Stevenson DD, Sanchez-Borges M, Szczeklik A. Classification of allergic and pseudoallergic reactions to drugs that inhibit cyclooxygenase enzymes. Ann Allergy Asthma Immunol. 2001 Sep;87(3):177-80. doi: 10.1016/S1081-1206(10)62221-1. No abstract available.

    PMID: 11570612BACKGROUND

  • Hedman J, Kaprio J, Poussa T, Nieminen MM. Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study. Int J Epidemiol. 1999 Aug;28(4):717-22. doi: 10.1093/ije/28.4.717.

    PMID: 10480701BACKGROUND

  • Kasper L, Sladek K, Duplaga M, Bochenek G, Liebhart J, Gladysz U, Malolepszy J, Szczeklik A. Prevalence of asthma with aspirin hypersensitivity in the adult population of Poland. Allergy. 2003 Oct;58(10):1064-6. doi: 10.1034/j.1398-9995.2003.00267.x.

    PMID: 14510727BACKGROUND

  • Vally H, Taylor ML, Thompson PJ. The prevalence of aspirin intolerant asthma (AIA) in Australian asthmatic patients. Thorax. 2002 Jul;57(7):569-74. doi: 10.1136/thorax.57.7.569.

    PMID: 12096197BACKGROUND

  • Samter M, Beers RF Jr. Intolerance to aspirin. Clinical studies and consideration of its pathogenesis. Ann Intern Med. 1968 May;68(5):975-83. doi: 10.7326/0003-4819-68-5-975. No abstract available.

    PMID: 5646829BACKGROUND

  • Stevenson D SR, Zuraw BL. Sensitivity to aspirin and NSAIDs. Adkinson NJ YJ, Busse WW, et al., editor. Philadelphia: CV Mosby and Co.; 2003

    BACKGROUND

  • Nizankowska-Mogilnicka E, Bochenek G, Mastalerz L, Swierczynska M, Picado C, Scadding G, Kowalski ML, Setkowicz M, Ring J, Brockow K, Bachert C, Wohrl S, Dahlen B, Szczeklik A. EAACI/GA2LEN guideline: aspirin provocation tests for diagnosis of aspirin hypersensitivity. Allergy. 2007 Oct;62(10):1111-8. doi: 10.1111/j.1398-9995.2007.01409.x. Epub 2007 May 22.

    PMID: 17521312BACKGROUND

  • Mastalerz L, Setkowicz M, Sanak M, Szczeklik A. Hypersensitivity to aspirin: common eicosanoid alterations in urticaria and asthma. J Allergy Clin Immunol. 2004 Apr;113(4):771-5. doi: 10.1016/j.jaci.2003.12.323.

    PMID: 15100686BACKGROUND

  • Setkowicz M, Mastalerz L, Podolec-Rubis M, Sanak M, Szczeklik A. Clinical course and urinary eicosanoids in patients with aspirin-induced urticaria followed up for 4 years. J Allergy Clin Immunol. 2009 Jan;123(1):174-8. doi: 10.1016/j.jaci.2008.09.005. Epub 2008 Oct 8.

    PMID: 18842291BACKGROUND

  • Szczeklik A, Gryglewski RJ, Czerniawska-Mysik G. Relationship of inhibition of prostaglandin biosynthesis by analgesics to asthma attacks in aspirin-sensitive patients. Br Med J. 1975 Jan 11;1(5949):67-9. doi: 10.1136/bmj.1.5949.67.

    PMID: 1109660BACKGROUND

  • Wong JT, Nagy CS, Krinzman SJ, Maclean JA, Bloch KJ. Rapid oral challenge-desensitization for patients with aspirin-related urticaria-angioedema. J Allergy Clin Immunol. 2000 May;105(5):997-1001. doi: 10.1067/mai.2000.104571.

    PMID: 10808182BACKGROUND

  • Berges-Gimeno MP, Simon RA, Stevenson DD. Long-term treatment with aspirin desensitization in asthmatic patients with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2003 Jan;111(1):180-6. doi: 10.1067/mai.2003.7.

    PMID: 12532116BACKGROUND

  • 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

  • Stevenson DD. Aspirin sensitivity and desensitization for asthma and sinusitis. Curr Allergy Asthma Rep. 2009 Mar;9(2):155-63. doi: 10.1007/s11882-009-0023-4.

    PMID: 19210906BACKGROUND

  • Stevenson DD, Hankammer MA, Mathison DA, Christiansen SC, Simon RA. Aspirin desensitization treatment of aspirin-sensitive patients with rhinosinusitis-asthma: long-term outcomes. J Allergy Clin Immunol. 1996 Oct;98(4):751-8. doi: 10.1016/s0091-6749(96)70123-9.

    PMID: 8876550BACKGROUND

  • Sweet JM, Stevenson DD, Simon RA, Mathison DA. Long-term effects of aspirin desensitization--treatment for aspirin-sensitive rhinosinusitis-asthma. J Allergy Clin Immunol. 1990 Jan;85(1 Pt 1):59-65. doi: 10.1016/0091-6749(90)90222-p.

    PMID: 2299107BACKGROUND

  • Macy E, Bernstein JA, Castells MC, Gawchik SM, Lee TH, Settipane RA, Simon RA, Wald J, Woessner KM; Aspirin Desensitization Joint Task Force. Aspirin challenge and desensitization for aspirin-exacerbated respiratory disease: a practice paper. Ann Allergy Asthma Immunol. 2007 Feb;98(2):172-4. doi: 10.1016/S1081-1206(10)60692-8.

    PMID: 17304886BACKGROUND

  • Romano A, Torres MJ, Castells M, Sanz ML, Blanca M. Diagnosis and management of drug hypersensitivity reactions. J Allergy Clin Immunol. 2011 Mar;127(3 Suppl):S67-73. doi: 10.1016/j.jaci.2010.11.047.

    PMID: 21354502BACKGROUND

  • Wismol P, Putivoranat P, Buranapraditkun S, Pinnobphun P, Ruxrungtham K, Klaewsongkram J. The values of nasal provocation test and basophil activation test in the different patterns of ASA/NSAID hypersensitivity. Allergol Immunopathol (Madr). 2012 May-Jun;40(3):156-63. doi: 10.1016/j.aller.2010.12.011. Epub 2011 Apr 13.

    PMID: 21492991BACKGROUND

  • Alonso-Llamazares A, Martinez-Cocera C, Dominguez-Ortega J, Robledo-Echarren T, Cimarra-Alvarez M, Mesa del Castillo M. Nasal provocation test (NPT) with aspirin: a sensitive and safe method to diagnose aspirin-induced asthma (AIA). Allergy. 2002 Jul;57(7):632-5. doi: 10.1034/j.1398-9995.2002.t01-1-13447.x.

    PMID: 12100305BACKGROUND

  • Milewski M, Mastalerz L, Nizankowska E, Szczeklik A. Nasal provocation test with lysine-aspirin for diagnosis of aspirin-sensitive asthma. J Allergy Clin Immunol. 1998 May;101(5):581-6. doi: 10.1016/S0091-6749(98)70163-0.

    PMID: 9600492BACKGROUND

  • Krane Kvenshagen B, Jacobsen M, Halvorsen R. Can conjunctival provocation test facilitate the diagnosis of food allergy in children? Allergol Immunopathol (Madr). 2010 Nov-Dec;38(6):321-6. doi: 10.1016/j.aller.2010.01.007. Epub 2010 Jun 4.

    PMID: 20605314BACKGROUND

  • Kralinger MT, Hamasaki D, Kieselbach GF, Voigt M, Parel JM. Intravitreal acetylsalicylic acid in silicone oil: pharmacokinetics and evaluation of its safety by ERG and histology. Graefes Arch Clin Exp Ophthalmol. 2001 Mar;239(3):208-16. doi: 10.1007/s004170100255.

    PMID: 11405070BACKGROUND

  • Kralinger MT, Stolba U, Velikay M, Egger S, Binder S, Wedrich A, Haas A, Parel JM, Kieselbach GF. Safety and feasibility of a novel intravitreal tamponade using a silicone oil/acetyl-salicylic acid suspension for proliferative vitreoretinopathy: first results of the Austrian Clinical Multicenter Study. Graefes Arch Clin Exp Ophthalmol. 2010 Aug;248(8):1193-8. doi: 10.1007/s00417-010-1389-7. Epub 2010 Apr 28.

    PMID: 20424852BACKGROUND

  • Voigt M, Kralinger M, Kieselbach G, Chapon P, Anagnoste S, Hayden B, Parel JM. Ocular aspirin distribution: a comparison of intravenous, topical, and coulomb-controlled iontophoresis administration. Invest Ophthalmol Vis Sci. 2002 Oct;43(10):3299-306.

    PMID: 12356838BACKGROUND

MeSH Terms

Conditions

Asthma, Aspirin-InducedAsthma, Nasal Polyps, And Aspirin Intolerance

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Gregor Bachmann-Harildstad, MD, PhD

    University in Oslo

    STUDY CHAIR

Central Study Contacts

Gregor Bachmann-Harlidstad, MD, PhD

CONTACT

0047 02900 (central)Gregor.Bachmann-Harlidstad2@ahus.no

Jörg Törpel, MD

CONTACT

0047 05151 (central)jörg.törpel@sus.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

September 10, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations

NO(2)