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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.01.2023

Trial locations

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.

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 ID:
2024-517437-40-00
Protocol code:
S67072
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

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  • Study on Aspirin’s Role in Reducing COVID-19 Risk for Patients with Aspirin-Exacerbated Respiratory Disease

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    1 1 1
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