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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000698-22 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Akershus | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylsalicylate | Active Comparator | Acetylsalicylic Acid Eyedrops |
|
| isotonic NaCl | Placebo Comparator | Saline Eyedrops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylate | Drug | 1-2 drops |
| |
| Isotonic NaCl |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Nasal symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Gregor Bachmann-Harildstad, MD, PhD | University in Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Akershus | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11570612 | Background | 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. | |
| 10480701 | Background | 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. |
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| ID | Term |
|---|---|
| D055963 | Asthma, Aspirin-Induced |
| C565935 | Asthma, Nasal Polyps, And Aspirin Intolerance |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Drug |
1 drop |
|
Rhinorrhea, congestion and sneezing is considered as positive test. |
| Within 45 minutes from challenge |
| Bronchial and laryngeal symptoms | Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test. | Within 45 minutes from challenge |
| Stavanger University Hospital | Stavanger | Rogaland | 4068 | Norway |
|
| 14510727 | Background | 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. |
| 12096197 | Background | 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. |
| 5646829 | Background | 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. |
| Background | Stevenson D SR, Zuraw BL. Sensitivity to aspirin and NSAIDs. Adkinson NJ YJ, Busse WW, et al., editor. Philadelphia: CV Mosby and Co.; 2003 |
| 17521312 | 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. |
| 15100686 | Background | 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. |
| 18842291 | Background | 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. |
| 1109660 | Background | 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. |
| 10808182 | Background | 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. |
| 12532116 | Background | 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. |
| 18699939 | Background | 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. |
| 19210906 | Background | 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. |
| 8876550 | Background | 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. |
| 2299107 | Background | 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. |
| 17304886 | Background | 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. |
| 21354502 | Background | 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. |
| 21492991 | Background | 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. |
| 12100305 | Background | 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. |
| 9600492 | Background | 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. |
| 20605314 | Background | 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. |
| 11405070 | Background | 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. |
| 20424852 | Background | 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. |
| 12356838 | Background | 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. |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |