Aspirin-Exacerbated Respiratory Disease (AERD) in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) MedDRA version: 25.1 Level: LLT Classification code 10075084 Term: Aspirin-exacerbated respiratory disease System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Aspegic 500 mg - powder for oral solution
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: D,L-Lysine Acetylsalicylate
CAS Number: 62952-06-1
Other descriptive
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient has N-ERD: intolerance to aspirin is confirmed by a nasal lysine-aspirin provocation test in the pre-trial S65796 (EUDRACT: 2022-000215-31) - Patients older than 18 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Female who is pregnant or breast-feeding. - 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 24 hours) for treatment of asthma within 3 months before screening - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: (1) Effect of nasal lysine-aspirin on upper and lower airway: - Peak Nasal Inspiratory Flow (PNIF), - Smell score (UPSIT), - Forced Expiratory Volume in 1 second (FEV1), - Bronchial and nasal inflammation (Fractional exhaled NO (FeNO) and nasal NO (nNO). (2) Effect of nasal lysine-aspirin on polyp growth: - Nasal Polyp Score (NPS), - The ability in reducing the proportion of patients who require surgery for nasal poyps (NP) (3) Effect of nasal lysine-aspirin on corticosteroid use: - The ability in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) for relief of chronic rhinosinusitis and asthma exacerbations. - Changes in dosage of inhaled/intranasal corticosteroids) ;Primary end point(s): -Change from baseline in VAS for rhinosinusitis and asthma severity -Change from baseline in NC score -Change from baseline in ACQ-6 score -Change from baseline in SNOT-22 score -Change from baseline in AQLQ(S) -Change from baseline in PGIC -Change from baseline in sQODNS score -Change from baseline in EQ-5D-5L -Change from baseline in provoking dose ;Timepoint(s) of evaluation of this end point: At the end of the trial ;Main Objective: (1) Effect of nasal ATAD with lysine-aspirin on patient reported outcomes: - Rhinosinusitis and Asthma severity Visual analogue scale (VAS) - Nasal Congestion/Obstruction (NC) score - Short version of the Olfactory Disorders-Negative Statements (sQODNS) - Asthma control, measured with the Asthma Control Questionnaire (ACQ-6); - 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)); - Patient recognition of improvement: Patient Global Impression of Change (PGIC). - 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in PNIF - Change from baseline in smell score (UPSIT) - Change from baseline in FEV1 - Change from baseline in FeNO and nNO - Change from baseline in NPS - Proportion of patients who have or are planned for surgery of nasal polyps, as well as time-to-event - Proportion of patients with OCS use for chronic rhinosinusitis/asthma exacerbation, as well as time to first course, number of courses, total dose used, total duration. - Dosage (dose and frequency) of inhaled/intranasal corticosteroids, reported as dosage during desensitisation and dosage during maintenance therapy (after goal of escalation is reached). ;Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Countries
Belgium
Contacts
Public ContactOtorhinolaryngology, head and neck
UZ Leuven
Outcome results
None listed