Challenge Test for Acetylsalicylic Acid Hypersensitivity

Asthma, Aspirin-Induced Clinical Trial

Official title:

Challenge Test for Acetylsalicylic Acid Hypersensitivity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01681615
• Other study ID #: ASA-ST-OS
• Secondary ID: 2012-000698-22
• Status: Not yet recruiting
• Phase: N/A
• First received: August 9, 2012
• Last updated: September 12, 2012
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: Helse Stavanger HF
• Contact: Gregor Bachmann-Harlidstad, MD, PhD
• Phone: 0047 02900 (central)
• Email: Gregor.Bachmann-Harlidstad2[@]ahus.no
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• ASA Intolerant Asthma
• Asthma
• Asthma Aspirin-sensitive
• Asthma, Aspirin-Induced
• Asthma, Nasal Polyps, and Aspirin Intolerance
• Hypersensitivity
• Nasal Polyps

Intervention

Drug:
• Acetylsalicylate
1-2 drops
• Isotonic NaCl
1 drop

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Akershus
Norway	Stavanger University Hospital	Stavanger	Rogaland

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (25)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nizankowska-Mogilnicka E, Bochenek G, Mastalerz L, Swierczynska 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. — View Citation

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. — View Citation

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. — View Citation

Samter M, Beers RF Jr. Intolerance to aspirin. Clinical studies and consideration of its pathogenesis. Ann Intern Med. 1968 May;68(5):975-83. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Stevenson DD. Aspirin sensitivity and desensitization for asthma and sinusitis. Curr Allergy Asthma Rep. 2009 Mar;9(2):155-63. Review. — View Citation

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. — View Citation

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. — View Citation

Vally H, Taylor ML, Thompson PJ. The prevalence of aspirin intolerant asthma (AIA) in Australian asthmatic patients. Thorax. 2002 Jul;57(7):569-74. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other significant and relevant symptoms	Erythema in upper body or face, nausea or abdominal pain is considered as positive test.	Within 45 days after challenge	Yes
Primary	Inspiratory nasal flow measured by Rhinomanometry	Bilateral flow reduction >40% considered positive test.	Within 45 min from challenge	No
Primary	Expiratory nasal flow measured by Rhinomanometry	Bilateral expiratory flow reduction >40% considered positive.	Within 45 min from challenge	No
Primary	Pulmonary forced expiratory volume in 1 second (FEV1)	Reduction in FEV1 >20% is considered as positive test.	Within 45 min from challenge	No
Secondary	Conjunctival symptoms	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.	Within 45 days from challenge	No
Secondary	Nasal symptoms	Rhinorrhea, congestion and sneezing is considered as positive test.	Within 45 minutes from challenge	No
Secondary	Bronchial and laryngeal symptoms	Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.	Within 45 minutes from challenge	Yes