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Patient reported efficacy of intranasal lysine-aspirin in controlling NSAID-exacerbated respiratory disease.
EU CTIS ID: 2024-517437-40-00
What this study is testing
1) Effect of nasal ATAD with lysine-aspirin on patient reported outcomes: o Rhinosinusitis and Asthma severity Visual analogue scale (VAS) o Nasal Congestion/Obstruction (NC) score o Short version of the Olfactory Disorders-Negative Statements (sQODNS) o Asthma control, measured with the Asthma Control Questionnaire (ACQ-6); o Health-related quality of life, using disease-specific health-related quality of life score, such as the Sino-Nasal Outcome Test-22 (SNOT-22) and the Standardised Asthma Quality of Life Questionnaire (AQLQ (S)); o Patient recognition of improvement: Patient Global Impression of Change (PGIC). o EQ-5D-5L to describe and value health 2) Incidence of significant serious and non-serious adverse events related to gastro- intestinal disturbance (nausea, vomiting, diarrhoea, abdominal pain). 3) Effect of nasal ATAD on provoking dose during nasal lysine-aspirin provocation test
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner
- Patient has N-ERD: intolerance to aspirin is confirmed by a nasal lysine-aspirin provocation test in the pre-trial S65796
- Patients older than 18 years
- Patient is using mometasone furoate or fluticasone propionate on a dose regimen of 2 actuations in each nostril once daily for at least 2 weeks before the screening visit
You likely can't join if
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Participants who have undergone any intranasal and/or sinus surgery (including polypectomy) within 2 months before screening
- Participants with major anatomical nasal abnormalities or conditions/concomitant diseases being responsible for nasal obstruction and making them nonevaluable at screening, but not limited to: antrochoanal polyps, nasal septal deviation that would occlude at least one nostril, acute sinusitis, nasal infection or upper respiratory infection requiring treament with systemic antibiotics, antivirals or antifungals, ongoing rhinitis medicamentosa, fungal rhinosinusitis
- Participants who have taken biologic therapy within 3 months prior to screening or 5 half-lives, whichever is longer
- Participants not willing to respect the requirements as defined in section 5.3 ‘Concomitant/Prohibited Medication/Treatment’
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
See the full eligibility criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner
- Patient has N-ERD: intolerance to aspirin is confirmed by a nasal lysine-aspirin provocation test in the pre-trial S65796
- Patients older than 18 years
- Patient is using mometasone furoate or fluticasone propionate on a dose regimen of 2 actuations in each nostril once daily for at least 2 weeks before the screening visit
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Participants who have undergone any intranasal and/or sinus surgery (including polypectomy) within 2 months before screening
- Participants with major anatomical nasal abnormalities or conditions/concomitant diseases being responsible for nasal obstruction and making them nonevaluable at screening, but not limited to: antrochoanal polyps, nasal septal deviation that would occlude at least one nostril, acute sinusitis, nasal infection or upper respiratory infection requiring treament with systemic antibiotics, antivirals or antifungals, ongoing rhinitis medicamentosa, fungal rhinosinusitis
- Participants who have taken biologic therapy within 3 months prior to screening or 5 half-lives, whichever is longer
- Participants not willing to respect the requirements as defined in section 5.3 ‘Concomitant/Prohibited Medication/Treatment’
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Female who is pregnant or breast-feeding
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Participants with severe gastro-intestinal disease or with bleeding diathesis
- Participants with chronic urticaria
- Participants with unstable cardiovascular conditions/cardiopulmonary disease where epinephrine is contraindicated
- Participants with severe chronic obstructive pulmonary disease (COPD)
- Participants with poorly controlled asthma defined as: a) FEV1 < 65 % predicted (before the start of the study treatment) while on preventative inhalers, or b) Participants who experienced an asthma exacerbation requiring hospitalization (>24 hours) for treatment of asthma within 3 months before screening
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.