Challenge Test for Acetylsalicylic Acid Hypersensitivity - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	Challenge Test for Acetylsalicylic Acid Hypersensitivity

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Aspirin

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
Bilateral flow reduction >40% considered positive test.
Expiratory nasal flow measured by Rhinomanometry [ Time Frame: Within 45 min from challenge ] [ Designated as safety issue: No ]
Bilateral expiratory flow reduction >40% considered positive.
Pulmonary forced expiratory volume in 1 second (FEV1) [ Time Frame: Within 45 min from challenge ] [ Designated as safety issue: No ]
Reduction in FEV1 >20% is considered as positive test.

Secondary Outcome Measures:

Conjunctival symptoms [ Time Frame: Within 45 days from challenge ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Rhinorrhea, congestion and sneezing is considered as positive test.
Bronchial and laryngeal symptoms [ Time Frame: Within 45 minutes from challenge ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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. PubMed PMID: 5646829.

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.

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. 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.

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.

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.

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.

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.

Responsible Party:	Helse Stavanger HF
ClinicalTrials.gov Identifier:	NCT01681615 History of Changes
Other Study ID Numbers:	ASA-ST-OS, 2012-000698-22
Study First Received:	August 9, 2012
Last Updated:	September 12, 2012
Health Authority:	Norway: Norwegian Medicines Agency Norway: Ethics Committee

Keywords provided by Helse Stavanger HF:

Challenge test for Aspirin Hypersensitivity
Challenge test for Acetylsalicylic Hypersensitivity

Additional relevant MeSH terms:

Asthma
Asthma, Aspirin-Induced
Hypersensitivity
Nasal Polyps
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
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013