Asthma, Aspirin-InducedPhase 4NCT01867281
The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
A Phase 4 study testing aspirin in people with Asthma, Aspirin-Induced, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the effect of aspirin desensitization on symptoms and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma, Aspirin-Induced
- What is being tested?
- aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIran
- Study dates
- Jun 2013to Jun 2014
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical diagnose of aspirin-exacerbated respiratory disease
- History of physician diagnosed asthma.
- History of physiacian diagnosed chronic rhinosinositis with nasal polyps.
- Positive reaction to aspirin challenge test.
- Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
Who cannot join
- Being smoker
- pregnancy
- Current breastfeeding
- History of bleeding diathesis
- History of transient ischemic attack or stroke, or diabetes.
- History of abnormal hepatic function
- Uncontrolled hypertension or use of beta blocker medication.
- History of gastrointestinal ulcers or gastrointestinal bleeding.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences
Tehran, Tehran Province
About this study
The purpose of this study is to determine the effect of aspirin desensitization on symptoms and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).
- Conditions
- Asthma, Aspirin-Induced
- Being tested
- aspirin
- Keywords
- aspirin, asthma, Aspirin desensitization, Aspirin induced asthma, Immune System Diseases, Respiratory Hypersensitivity
- Medical subject headings
- Asthma, Aspirin-Induced, Asthma, Immune System Diseases, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Aspirin | Active comparator | Participants will undergo aspirin desensitization over a 2-day period with increasing doses of aspirin (60, 125, 325 and 625 mg). Thereafter,they will be followed with 625 mg aspirin bid. Receives: Drug: aspirin |
| Control: placebo | Placebo comparator | Participants will receive placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SNOT-22 scores from Baseline
At baseline and 6 months after treatment, all participants will complete the SNOT-22 questionnaire. SNOT-22 is a validated disease specific questionnaire that assesses the health related quality of life patients.
Measured: 6 months
change in serum concentration of IL-10
At baseline and 6 months after treatment, serum level of IL-10 will be investigated for all participants.
Measured: 6 months
change in concentration of serum TGF-beta
At baseline and 6 months after treatment, serum level of TGF-beta will be investigated for all participants
Measured: 6 months
change in concentration of serum IFN-gamma
At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.
Measured: 6 months
Secondary outcomes (4)
Lund Mackay score
For all participants, Lund Mackay will be scored by investigators.
Measured: 6 months
Asthma attacks
Number of asthma attacks will be recorded for all participants over a 6-month follow up.
Measured: 6 months
medication needs
Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.
Measured: 6 months
FEV1
FEV1 for all patients will be assessed using spirometery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Asthma, Aspirin-InducedStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Rassoul Akram Hospital
- Responsible party
- Sponsor
- Investigators
- Hossein Esmaeilzadeh, MD, Study director, Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.Mohammad Nabavi, MD, Study chair, Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.Zahra Aryan, MD, MPH, student, Principal investigator, Molecular Immunology Research Center, Tehran University of Medical Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867281
- Sponsor's protocol ID
- 92-01-119-20728
- Status last verified
- Jun 2014
- First submitted
- 29 May 2013
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Katial RK, Strand M, Prasertsuntarasai T, Leung R, Zheng W, Alam R. The effect of aspirin desensitization on novel biomarkers in aspirin-exacerbated respiratory diseases. J Allergy Clin Immunol. 2010 Oct;126(4):738-44. doi: 10.1016/j.jaci.2010.06.036. Epub 2010 Aug 21.
PubMed 20728206White AA, Stevenson DD. Does suppression of IL-4 synthesis by aspirin explain the therapeutic benefit of aspirin desensitization treatment? J Allergy Clin Immunol. 2010 Oct;126(4):745-6. doi: 10.1016/j.jaci.2010.08.037. No abstract available.
PubMed 20920763Rozsasi 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 18699939Menzies D, Nair A, Meldrum KT, Hopkinson P, Lipworth BJ. Effect of aspirin on airway inflammation and pulmonary function in patients with persistent asthma. J Allergy Clin Immunol. 2008 May;121(5):1184-1189.e4. doi: 10.1016/j.jaci.2008.01.009. Epub 2008 Mar 4.
PubMed 18313127Swierczynska M, Nizankowska-Mogilnicka E, Zarychta J, Gielicz A, Szczeklik A. Nasal versus bronchial and nasal response to oral aspirin challenge: Clinical and biochemical differences between patients with aspirin-induced asthma/rhinitis. J Allergy Clin Immunol. 2003 Nov;112(5):995-1001. doi: 10.1016/s0091-6749(03)02015-3.
PubMed 14610494Vaidyanathan S, Williamson PA, Lipworth BJ. Is a positive nasal lysine-aspirin challenge test associated with a more severe phenotype of chronic rhinosinusitis and asthma? Am J Rhinol Allergy. 2012 May-Jun;26(3):e89-93. doi: 10.2500/ajra.2012.26.3767.
PubMed 22643934Higashi N, Taniguchi M, Mita H, Yamaguchi H, Ono E, Akiyama K. Aspirin-intolerant asthma (AIA) assessment using the urinary biomarkers, leukotriene E4 (LTE4) and prostaglandin D2 (PGD2) metabolites. Allergol Int. 2012 Sep;61(3):393-403. doi: 10.2332/allergolint.11-RA-0403. Epub 2012 May 25.
PubMed 22627848Chang JE, White A, Simon RA, Stevenson DD. Aspirin-exacerbated respiratory disease: burden of disease. Allergy Asthma Proc. 2012 Mar-Apr;33(2):117-21. doi: 10.2500/aap.2012.33.3541.
PubMed 22525387
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
- ClinicalTrials.gov ID
- NCT01867281
- Acronym / sponsor ID
- 92-01-119-20728
- Conditions
- Asthma, Aspirin-Induced
- Keywords
- aspirin, asthma, Aspirin desensitization, Aspirin induced asthma, Immune System Diseases, Respiratory Hypersensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Rassoul Akram Hospital
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Jun 2013 (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 purpose of this study is to determine the effect of aspirin desensitization on symptoms and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Aspirin | Active comparator | Drug: aspirinParticipants will undergo aspirin desensitization over a 2-day period with increasing doses of aspirin (60, 125, 325 and 625 mg). Thereafter,they will be followed with 625 mg aspirin bid. |
| Control: placebo | Placebo comparator | –Participants will receive placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with clinical diagnose of aspirin-exacerbated respiratory disease
- History of physician diagnosed asthma.
- History of physiacian diagnosed chronic rhinosinositis with nasal polyps.
- Positive reaction to aspirin challenge test.
- Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
Key exclusion criteria (8 listed)
- Being smoker
- pregnancy
- Current breastfeeding
- History of bleeding diathesis
- History of transient ischemic attack or stroke, or diabetes.
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 |
|---|---|---|
| aspirin | Drug | Intervention: Aspirin |
Primary outcome
Change in SNOT-22 scores from Baseline
Time frame: 6 months
At baseline and 6 months after treatment, all participants will complete the SNOT-22 questionnaire. SNOT-22 is a validated disease specific questionnaire that assesses the health related quality of life patients.
change in serum concentration of IL-10
Time frame: 6 months
At baseline and 6 months after treatment, serum level of IL-10 will be investigated for all participants.
change in concentration of serum TGF-beta
Time frame: 6 months
At baseline and 6 months after treatment, serum level of TGF-beta will be investigated for all participants
change in concentration of serum IFN-gamma
Time frame: 6 months
At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.
4 secondary outcomes
Lund Mackay score
Time frame: 6 months
Asthma attacks
Time frame: 6 months
medication needs
Time frame: 6 months
FEV1
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Background: PubMed 20728206Katial RK, Strand M, Prasertsuntarasai T, Leung R, Zheng W, Alam R. The effect of aspirin desensitization on novel biomarkers in aspirin-exacerbated respiratory diseases. J Allergy Clin Immunol. 2010 Oct;126(4):738-44. doi: 10.1016/j.jaci.2010.06.036. Epub 2010 Aug 21.
- Background: PubMed 20920763White AA, Stevenson DD. Does suppression of IL-4 synthesis by aspirin explain the therapeutic benefit of aspirin desensitization treatment? J Allergy Clin Immunol. 2010 Oct;126(4):745-6. doi: 10.1016/j.jaci.2010.08.037. No abstract available.
- Background: PubMed 18699939Rozsasi 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.
- Background: PubMed 18313127Menzies D, Nair A, Meldrum KT, Hopkinson P, Lipworth BJ. Effect of aspirin on airway inflammation and pulmonary function in patients with persistent asthma. J Allergy Clin Immunol. 2008 May;121(5):1184-1189.e4. doi: 10.1016/j.jaci.2008.01.009. Epub 2008 Mar 4.
- Background: PubMed 14610494Swierczynska M, Nizankowska-Mogilnicka E, Zarychta J, Gielicz A, Szczeklik A. Nasal versus bronchial and nasal response to oral aspirin challenge: Clinical and biochemical differences between patients with aspirin-induced asthma/rhinitis. J Allergy Clin Immunol. 2003 Nov;112(5):995-1001. doi: 10.1016/s0091-6749(03)02015-3.
- Background: PubMed 22643934Vaidyanathan S, Williamson PA, Lipworth BJ. Is a positive nasal lysine-aspirin challenge test associated with a more severe phenotype of chronic rhinosinusitis and asthma? Am J Rhinol Allergy. 2012 May-Jun;26(3):e89-93. doi: 10.2500/ajra.2012.26.3767.
- Background: PubMed 22627848Higashi N, Taniguchi M, Mita H, Yamaguchi H, Ono E, Akiyama K. Aspirin-intolerant asthma (AIA) assessment using the urinary biomarkers, leukotriene E4 (LTE4) and prostaglandin D2 (PGD2) metabolites. Allergol Int. 2012 Sep;61(3):393-403. doi: 10.2332/allergolint.11-RA-0403. Epub 2012 May 25.
- Background: PubMed 22525387Chang JE, White A, Simon RA, Stevenson DD. Aspirin-exacerbated respiratory disease: burden of disease. Allergy Asthma Proc. 2012 Mar-Apr;33(2):117-21. doi: 10.2500/aap.2012.33.3541.
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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.
Hossein Esmaeilzadeh, MD study director
Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.
Mohammad Nabavi, MD study chair
Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.
Zahra Aryan, MD, MPH, student principal investigator
Molecular Immunology Research Center, Tehran University of Medical Sciences.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin in people with Asthma, Aspirin-Induced, run by Tehran University of Medical Sciences at 1 site in Iran.
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 5 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: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SNOT-22 scores from Baseline (time frame: 6 months). The study lists 4 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 NCT01867281, which also lists 8 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 1 Jul 2014.