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Challenge Test for Acetylsalicylic Acid Hypersensitivity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Helse Stavanger HF.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681615
First Posted: September 10, 2012
Last Update Posted: September 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Helse Stavanger HF
  Purpose
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.

Condition Intervention
Asthma Aspirin-sensitive ASA Intolerant Asthma Asthma, Aspirin-Induced Asthma, Nasal Polyps, and Aspirin Intolerance Drug: Acetylsalicylate Drug: Isotonic NaCl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Challenge Test for Acetylsalicylic Acid Hypersensitivity

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Inspiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ]
    Bilateral flow reduction >40% considered positive test.

  • Expiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ]
    Bilateral expiratory flow reduction >40% considered positive.

  • Pulmonary forced expiratory volume in 1 second (FEV1) [ Time Frame: Within 45 min from challenge ]
    Reduction in FEV1 >20% is considered as positive test.


Secondary Outcome Measures:
  • Conjunctival symptoms [ Time Frame: Within 45 days from challenge ]

    0=no symptoms, 1=limited redness and / or itching, 2=conjunctival redness and /or itching / swelling or bullae within 5 minutes from testing.

    Value 1 and 2 is considered positive if unilateral.


  • Nasal symptoms [ Time Frame: Within 45 minutes from challenge ]
    Rhinorrhea, congestion and sneezing is considered as positive test.

  • Bronchial and laryngeal symptoms [ Time Frame: Within 45 minutes from challenge ]
    Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.


Other Outcome Measures:
  • Other significant and relevant symptoms [ Time Frame: Within 45 days after challenge ]
    Erythema in upper body or face, nausea or abdominal pain is considered as positive test.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetylsalicylate
Acetylsalicylic Acid Eyedrops
Drug: Acetylsalicylate
1-2 drops
Placebo Comparator: isotonic NaCl
Saline Eyedrops
Drug: Isotonic NaCl
1 drop

Detailed Description:
Hypersensitivity to Acetylsalicylic Acid or Aspirin (and other NSAIDS) is a condition that affects up to 2,5% of the population. Most cases are seen in a complex of such hypersensitivity with chronic eosinophilic rhinosinusitis with nasal polyposis and asthma. Despite research in finding a reliable in-vitro-test for the condition, challenge tests are still considered gold standard. So far oral, nasal, inhalation and intravenous routes of administration has been described in literature.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681615


Contacts
Contact: Gregor Bachmann-Harlidstad, MD, PhD 0047 02900 (central) Gregor.Bachmann-Harlidstad2@ahus.no
Contact: Jörg Törpel, MD 0047 05151 (central) jörg.törpel@sus.no

Locations
Norway
Akershus University Hospital Not yet recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Gregor Bachmann-Harlidstad, MD, PhD    0047 02900 (central)    gregor.bachmann.harlidstad2@ahus.no   
Contact: Mohammad Sohrabi, MD    0047 02900 (central)    mohammad.sohrabi@ahus.no   
Principal Investigator: Gregor Bachmann-Harildstad, MD, PhD         
Sub-Investigator: Mohammad Sohrabi, MD         
Stavanger University Hospital Not yet recruiting
Stavanger, Rogaland, Norway, 4068
Contact: Anders Torp, MD    0047 05151 (central)    anders.torp@sus.no   
Contact: Jörg Törpel, MD    0047 05151 (central)    jörg.törpel@sus.no   
Sub-Investigator: Anders Torp, MD         
Sub-Investigator: Jörg Törpel, MD         
Sponsors and Collaborators
Helse Stavanger HF
University Hospital, Akershus
Investigators
Study Chair: Gregor Bachmann-Harildstad, MD, PhD University in Oslo
  More Information

Publications:
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.
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.
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.
Vally H, Taylor ML, Thompson PJ. The prevalence of aspirin intolerant asthma (AIA) in Australian asthmatic patients. Thorax. 2002 Jul;57(7):569-74.
Samter M, Beers RF Jr. Intolerance to aspirin. Clinical studies and consideration of its pathogenesis. Ann Intern Med. 1968 May;68(5):975-83.
Stevenson D SR, Zuraw BL. Sensitivity to aspirin and NSAIDs. Adkinson NJ YJ, Busse WW, et al., editor. Philadelphia: CV Mosby and Co.; 2003
Nizankowska-Mogilnicka E, Bochenek G, Mastalerz L, Swierczyńska M, Picado C, Scadding G, Kowalski ML, Setkowicz M, Ring J, Brockow K, Bachert C, Wöhrl S, Dahlén B, Szczeklik A. EAACI/GA2LEN guideline: aspirin provocation tests for diagnosis of aspirin hypersensitivity. Allergy. 2007 Oct;62(10):1111-8. Epub 2007 May 22. Review.
Stevenson DD, Szczeklik A. Clinical and pathologic perspectives on aspirin sensitivity and asthma. J Allergy Clin Immunol. 2006 Oct;118(4):773-86; quiz 87-8. 9. 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
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.
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.
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.
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.
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.
Stevenson DD. Aspirin sensitivity and desensitization for asthma and sinusitis. Curr Allergy Asthma Rep. 2009 Mar;9(2):155-63. Review.
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.
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.
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.
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.
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.
Alonso-Llamazares A, Martinez-Cócera C, Domínguez-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.
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.
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.
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.
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.
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.
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.

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01681615     History of Changes
Other Study ID Numbers: ASA-ST-OS
2012-000698-22 ( EudraCT Number )
First Submitted: August 9, 2012
First Posted: September 10, 2012
Last Update Posted: September 13, 2012
Last Verified: September 2012

Keywords provided by Helse Stavanger HF:
Challenge test for Aspirin Hypersensitivity
Challenge test for Acetylsalicylic Hypersensitivity

Additional relevant MeSH terms:
Asthma
Hypersensitivity
Nasal Polyps
Asthma, Aspirin-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action


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