Asthma Aspirin-sensitiveNCT01681615
Challenge Test for Acetylsalicylic Acid Hypersensitivity
A study testing Acetylsalicylate and Isotonic NaCl in people with Asthma Aspirin-sensitive and ASA Intolerant Asthma, run by Helse Stavanger HF at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma Aspirin-sensitive, ASA Intolerant Asthma, Asthma, Aspirin-Induced
- What is being tested?
- Acetylsalicylate and Isotonic NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persons between 18 and 60 years of age
- Suspected Acetylsalicylic Acid Hypersensitivity
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lørenskog, Akershus, 1478
Gregor Bachmann-Harlidstad, MD, PhD, 0047 02900 (central), gregor.bachmann.harlidstad2@ahus.no
Mohammad Sohrabi, MD, 0047 02900 (central), mohammad.sohrabi@ahus.no
Stavanger University Hospital
Stavanger, Rogaland, 4068
Anders Torp, MD, 0047 05151 (central), anders.torp@sus.no
Jörg Törpel, MD, 0047 05151 (central), jörg.törpel@sus.no
About this study
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.
Read the 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.
- Conditions
- Asthma Aspirin-sensitive, ASA Intolerant Asthma, Asthma, Aspirin-Induced, Asthma, Nasal Polyps, and Aspirin Intolerance
- Being tested
- Acetylsalicylate, Isotonic NaCl
- Keywords
- Challenge test for Aspirin Hypersensitivity, Challenge test for Acetylsalicylic Hypersensitivity
- Medical subject headings
- Asthma, Aspirin-Induced, Asthma, Nasal Polyps, And Aspirin Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylsalicylateDrug
1-2 drops
Isotonic NaClDrug
1 drop
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylate | Active comparator | Acetylsalicylic Acid Eyedrops Receives: Drug: Acetylsalicylate |
| isotonic NaCl | Placebo comparator | Saline Eyedrops Receives: Drug: Isotonic NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory nasal flow measured by Rhinomanometry
Bilateral flow reduction >40% considered positive test.
Measured: Within 45 min from challenge
Expiratory nasal flow measured by Rhinomanometry
Bilateral expiratory flow reduction >40% considered positive.
Measured: Within 45 min from challenge
Pulmonary forced expiratory volume in 1 second (FEV1)
Reduction in FEV1 >20% is considered as positive test.
Measured: Within 45 min from challenge
Secondary outcomes (3)
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.
Measured: Within 45 days from challenge
Nasal symptoms
Rhinorrhea, congestion and sneezing is considered as positive test.
Measured: Within 45 minutes from challenge
Bronchial and laryngeal symptoms
Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test.
Measured: Within 45 minutes from challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Asthma Aspirin-sensitiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Gregor Bachmann-Harildstad, MD, PhD, Study chair, University in Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681615
- Sponsor's protocol ID
- ASA-ST-OS
- Other IDs
- 2012-000698-22
- Status last verified
- Sep 2012
- First submitted
- 9 Aug 2012
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/S1081-1206(10)62221-1. No abstract available.
PubMed 11570612Hedman 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.
PubMed 10480701Kasper 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.
PubMed 14510727Vally 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.
PubMed 12096197Samter 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.
PubMed 5646829Stevenson 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, 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.
PubMed 17521312Mastalerz 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.
PubMed 15100686Setkowicz 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.
PubMed 18842291Szczeklik 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.
PubMed 1109660Wong 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.
PubMed 10808182Berges-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.
PubMed 12532116Rozsasi 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.
PubMed 18699939Stevenson 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.
PubMed 19210906Stevenson 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.
PubMed 8876550
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenge Test for Acetylsalicylic Acid Hypersensitivity
- ClinicalTrials.gov ID
- NCT01681615
- Acronym / sponsor ID
- ASA-ST-OS
- Conditions
- Asthma Aspirin-sensitive, ASA Intolerant Asthma, Asthma, Aspirin-Induced, Asthma, Nasal Polyps, and Aspirin Intolerance
- Keywords
- Challenge test for Aspirin Hypersensitivity, Challenge test for Acetylsalicylic Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University Hospital, Akershus
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylate | Active comparator | Drug: AcetylsalicylateAcetylsalicylic Acid Eyedrops |
| isotonic NaCl | Placebo comparator | Drug: Isotonic NaClSaline Eyedrops |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Persons between 18 and 60 years of age
- Suspected Acetylsalicylic Acid Hypersensitivity
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylate1-2 drops | Drug | Acetylsalicylate |
| Isotonic NaCl1 drop | Drug | isotonic NaCl |
Primary outcome
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.
3 secondary outcomes
Conjunctival symptoms
Time frame: Within 45 days from challenge
Nasal symptoms
Time frame: Within 45 minutes from challenge
Bronchial and laryngeal symptoms
Time frame: Within 45 minutes from challenge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
- Background: PubMed 11570612Stevenson 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.
- Background: PubMed 10480701Hedman 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.
- Background: PubMed 14510727Kasper 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.
- Background: PubMed 12096197Vally 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.
- Background: PubMed 5646829Samter 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.
- BackgroundStevenson D SR, Zuraw BL. Sensitivity to aspirin and NSAIDs. Adkinson NJ YJ, Busse WW, et al., editor. Philadelphia: CV Mosby and Co.; 2003
- Background: PubMed 17521312Nizankowska-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.
- Background: PubMed 15100686Mastalerz 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.
- Background: PubMed 18842291Setkowicz 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.
- Background: PubMed 1109660Szczeklik 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.
- Background: PubMed 10808182Wong 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.
- Background: PubMed 12532116Berges-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Bachmann-Harildstad, MD, PhD study chair
University in Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetylsalicylate and Isotonic NaCl in people with Asthma Aspirin-sensitive and ASA Intolerant Asthma, run by Helse Stavanger HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregor Bachmann-Harlidstad, MD, PhD (0047 02900 (central), Gregor.Bachmann-Harlidstad2@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory nasal flow measured by Rhinomanometry (time frame: Within 45 min from challenge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681615, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2012.