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Study of intranasal lysine-aspirin effectiveness in patients with NSAID-exacerbated respiratory disease (N-ERD)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Nonsteroidal Anti-inflammatory Drug Exacerbated Respiratory Disease (N-ERD), a condition where patients experience breathing difficulties and increased sensitivity to certain pain medications. The study will evaluate the effectiveness of nasal lysine-aspirin, a modified form of aspirin, in managing symptoms of this condition.

The purpose of the study is to determine how well nasal lysine-aspirin helps control symptoms and improve quality of life for people with N-ERD. The study will use acetylsalicylic acid (aspirin) and sodium chloride solution as part of the treatment. Participants will receive the medication through the nose over a period of 49 days.

During the study, researchers will track changes in breathing problems, nasal congestion, sense of smell, and overall quality of life. They will also monitor how well asthma symptoms are controlled and any stomach-related side effects that may occur. The treatment involves gradually increasing the medication dose while carefully observing how participants respond to the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your participation begins after completing the nasal lysine-aspirin provocation test that confirms aspirin intolerance.

    You must be using prescribed nasal spray (mometasone furoate or fluticasone propionate) - 2 sprays in each nostril daily for at least 2 weeks before starting.

  2. Step 2

    Baseline measurements

    You will complete several questionnaires about your symptoms:

    Assessment of nasal congestion and breathing difficulties

    Evaluation of sense of smell

    Questions about asthma control

    Quality of life assessment related to nose and sinus symptoms

    General health status evaluation

  3. Step 3

    Treatment phase

    You will receive intranasal lysine-aspirin treatment

    The medication will be administered through the nose

    Regular assessments will track changes in your symptoms

    Your breathing capacity and nasal airflow will be measured

    The sense of smell will be tested periodically

  4. Step 4

    Monitoring period

    Regular checks of lung function (FEV1 - amount of air you can exhale)

    Tracking any stomach-related side effects

    Assessment of nasal polyps

    Recording any changes in your regular medication use

    Documentation of any additional treatments needed for asthma or sinus problems

  5. Step 5

    Final evaluation

    Completion of all questionnaires to compare with initial responses

    Final assessment of symptoms and medication use

    Review of any side effects experienced during the study

    Measurement of final breathing and nasal function

Who can join the trial?

10 criteria

  • You must be at least 18 years old
  • You must provide voluntary written informed consent before any screening procedures
  • You must have confirmed aspirin intolerance through a nasal lysine-aspirin test in pre-trial S65796
  • You must be using mometasone furoate or fluticasone propionate (nasal sprays used to treat nasal symptoms) with 2 sprays in each nostril once daily for at least 2 weeks before the screening visit
  • You must use effective birth control methods that have a failure rate of less than 1% per year, such as:
    • Implants
    • Injectable contraceptives
    • Combined oral contraceptives
    • Certain types of IUDs
    • Complete sexual abstinence
    • Having a partner who has had a vasectomy

Who cannot join the trial?

13 criteria

  • Age below 18 or above 65 years
  • Active respiratory tract infection or sinus infection within the last 4 weeks
  • Pregnancy or breastfeeding
  • History of anaphylaxis (severe, life-threatening allergic reaction) to aspirin or other NSAIDs
  • Current use of anticoagulant medications (blood thinners)
  • Uncontrolled gastroesophageal reflux disease (chronic digestive condition where stomach acid flows back into the food pipe)
  • Active stomach ulcers or history of stomach bleeding
  • Severe asthma that is not well-controlled with current medications
  • History of nasal surgery in the past 3 months
  • Participation in any other clinical trial within the last 30 days
  • Known allergy to any component of the study medication
  • Significant kidney or liver disease
  • Unable to comply with study procedures or follow-up visits
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Investigated drugs

  • Lysine-aspirin

    is a form of aspirin that is administered as a nasal spray. It is used to treat a specific condition called NSAID-exacerbated respiratory disease, which affects both breathing and sinus function. The medication is delivered directly into the nose, which allows it to work locally in the nasal passages and sinuses. This form of treatment is different from regular oral aspirin tablets and is specifically designed for nasal use.

  • ATAD

    (Aspirin Treatment After Desensitization) is a therapeutic approach that involves carefully administering aspirin through the nose after the patient has undergone a process to reduce their sensitivity to aspirin. This treatment is used to help manage symptoms in patients who have respiratory problems triggered by aspirin or similar medications.

What is already known about the treatment

Lysine-aspirin - A specialized form of aspirin combined with lysine, administered intranasally for treating Nonsteroidal Anti-inflammatory Drug Exacerbated Respiratory Disease (N-ERD). This medication works by modifying the inflammatory response in the nasal passages and respiratory system, particularly in patients who experience adverse reactions to traditional NSAIDs. The treatment involves controlled local application through the nasal route, which helps to desensitize patients to aspirin and manage respiratory symptoms while minimizing systemic side effects. It belongs to the class of modified nonsteroidal anti-inflammatory drugs and is primarily used in specialized clinical settings for aspirin desensitization therapy.

Investigated diseases

Nonsteroidal Anti-inflammatory Drug Exacerbated Respiratory Disease (N-ERD) - A chronic medical condition characterized by the combination of asthma, recurring nasal polyps, and respiratory reactions to aspirin and other non-steroidal anti-inflammatory drugs. The condition typically begins with chronic nasal congestion and progresses to include loss of smell, sinus problems, and the development of nasal polyps. Patients experience worsening respiratory symptoms when taking aspirin or similar medications. The condition often involves chronic inflammation of both the upper and lower respiratory tract. The disease usually develops in adulthood and tends to be persistent.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517437-40-00Protocol codeS67072Estimated enrolment30 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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