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Nacystelyn

Nacystelyn (NAL), a mucolytic drug, is currently being studied in clinical trials for its potential benefits in treating Obstructive Sleep Apnea (OSA). This article explores the ongoing research on NAL’s effectiveness, safety, and impact on various sleep-related parameters in patients with OSA. The trials aim to assess whether NAL, administered through a dry-powder inhaler, can improve sleep quality and reduce the severity of OSA symptoms.

Table of Contents

What is NACYSTELYN?

NACYSTELYN, also known as NAL or L-LYSINE-N-ACETYL-L-CYSTEINATE, is a medication currently being studied for its potential benefits in treating Obstructive Sleep Apnea (OSA)[1]. It belongs to a class of drugs called mucolytics, which are typically used to help break down mucus in the airways[1]. However, in this study, researchers are exploring its potential as an antioxidant to help with sleep apnea.

Medical Condition: Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is a sleep disorder where a person’s breathing is repeatedly interrupted during sleep[1]. These interruptions occur when the throat muscles intermittently relax and block the airway during sleep. This can lead to poor sleep quality, daytime sleepiness, and other health problems if left untreated.

How NACYSTELYN Works

While the exact mechanism of how NACYSTELYN might help with OSA is not fully explained in the study details, researchers are investigating its potential as an antioxidant[1]. Antioxidants are substances that can protect cells from damage caused by free radicals. In the context of OSA, it’s believed that the repeated episodes of low oxygen (known as oxidative stress) during sleep might cause inflammation and damage to tissues. By using an antioxidant like NACYSTELYN, researchers hope to reduce this oxidative stress and potentially improve OSA symptoms.

How NACYSTELYN is Administered

NACYSTELYN is being tested in two forms:

  1. As a capsule (10 mg)[1]
  2. As an inhalation powder in a hard capsule (20 mg)[1]

Both forms are administered using a device called an AXAHALER, which is a Monodose Dry Powder Inhaler. This is a Class 1 device designed for oral inhalation only, which delivers the medication when you breathe in[1]. The maximum daily dose being tested is 40 mg for the capsule form and 80 mg for the inhalation powder form[1].

Who Can Participate in the NACYSTELYN Study?

The study is looking for adult participants with specific characteristics. Some key inclusion criteria are:

  • Adults with obstructive sleep apnea[1]
  • An Apnea-Hypopnea Index (AHI) between 15 and 30 per hour. (AHI is a measure of sleep apnea severity, indicating the number of breathing interruptions per hour of sleep)[1]
  • Participants who are new to CPAP (Continuous Positive Airway Pressure, a common treatment for OSA) or haven’t used it for at least two months[1]
  • An Oxygen Desaturation Index of 10 or more (This measures how often your blood oxygen level drops during sleep)[1]
  • A Body Mass Index (BMI) between 18 and 35 kg/m2[1]

There are also several exclusion criteria, such as recent upper respiratory infections, use of certain medications, and other health conditions that might interfere with the study results[1].

Study Objectives and Measurements

The main goal of this study is to see if NACYSTELYN can help improve OSA symptoms. Researchers will measure this primarily by looking at the change in the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment[1].

They will also look at many other factors, including:

  • Changes in the number and duration of apnea (breathing stops) and hypopnea (shallow breathing) episodes[1]
  • Oxygen levels during sleep[1]
  • Snoring patterns[1]
  • Daytime sleepiness[1]
  • Fatigue levels[1]
  • Changes in oxidative stress and inflammation markers in the body[1]

Potential Benefits of NACYSTELYN

If successful, NACYSTELYN could offer a new treatment option for people with OSA. Potential benefits might include:

  • Reduction in the number and severity of breathing interruptions during sleep[1]
  • Improved oxygen levels during sleep[1]
  • Reduced daytime sleepiness and fatigue[1]
  • Decreased oxidative stress and inflammation in the body[1]

However, it’s important to note that these potential benefits are still being studied and are not guaranteed.

Safety Considerations

As with any medical study, safety is a key concern. The researchers will be monitoring for any side effects or adverse reactions throughout the study[1]. Some people should not participate in this study, including those with:

  • Hypersensitivity to acetylcysteine (the active ingredient in NACYSTELYN) or similar substances[1]
  • Significant unstable heart disease[1]
  • COPD (Chronic Obstructive Pulmonary Disease) or asthma[1]
  • Pregnancy or nursing[1]

It’s crucial to discuss with your doctor before considering participation in any clinical trial or starting any new treatment for OSA.

Aspect Details
Drug Name Nacystelyn (NAL)
Administration Method Dry-Powder Inhaler (AXAHALER)
Condition Studied Obstructive Sleep Apnea (OSA)
Primary Objective Assess NAL’s benefit in OSA treatment
Primary Endpoint Change in Apnea-Hypopnea Index (AHI) after 6 weeks
Key Inclusion Criteria Adults with OSA, AHI 15-30/h, naïve to CPAP or untreated for 2+ months
Treatment Duration 6 weeks
Secondary Measurements Oxygen saturation, snoring patterns, sleepiness scores, sleep quality indicators
Safety Assessment Adverse events, vital signs, physical examination

FAQ

  • What is Nacystelyn (NAL) and how is it being used in the clinical trial? Nacystelyn (NAL) is a mucolytic drug being tested as a potential treatment for Obstructive Sleep Apnea (OSA). In the clinical trial, it is administered through a dry-powder inhaler called AXAHALER.
  • What is the main objective of the NAL clinical trial for OSA? The main objective is to assess if Nacystelyn (NAL) Dry-Powder Inhaler can be beneficial in the treatment of obstructive sleep apnea (OSA). The study aims to evaluate its effects on various sleep-related parameters and overall safety.
  • Who can participate in the NAL clinical trial for OSA? Participants must be adults with obstructive sleep apnea, have an Apnea-Hypopnea Index (AHI) between 15 and 30 per hour, be naïve to CPAP or not treated by CPAP for at least two months, and meet other specific criteria such as BMI requirements and absence of certain medical conditions.
  • What are the main measurements being taken in the NAL clinical trial? The primary measurement is the change in Apnea-Hypopnea Index (AHI) after 6 weeks of treatment. Other measurements include changes in oxygen saturation, snoring patterns, sleepiness scores, and various sleep quality indicators.
  • How long does the NAL treatment last in the clinical trial? The treatment period in the clinical trial lasts for 6 weeks, during which participants will be monitored for changes in their sleep apnea symptoms and overall sleep quality.

Ongoing Clinical Trials on Nacystelyn

  • Study of Nacystelyn for Patients with Obstructive Sleep Apnea

    Not recruiting

    1
    Investigated drugs:
    Belgium France

Glossary

  • Nacystelyn (NAL): A mucolytic drug being studied for its potential benefits in treating Obstructive Sleep Apnea. It is administered through a dry-powder inhaler.
  • Obstructive Sleep Apnea (OSA): A sleep disorder characterized by repeated episodes of complete or partial airway blockage during sleep, leading to disrupted breathing patterns.
  • Apnea-Hypopnea Index (AHI): A measure of sleep apnea severity, calculated by the number of apneas (breathing pauses) and hypopneas (shallow breaths) per hour of sleep.
  • CPAP: Continuous Positive Airway Pressure, a common treatment for sleep apnea that uses a machine to deliver constant air pressure to keep the airways open during sleep.
  • Dry-Powder Inhaler (DPI): A device used to deliver medication in the form of a dry powder directly into the lungs through inhalation.
  • Oxygen Desaturation Index (ODI): A measure of how often the blood oxygen level drops below normal during sleep, indicating the severity of sleep apnea.
  • Polysomnography (PSG): A comprehensive sleep study that records brain waves, blood oxygen levels, heart rate, breathing, and eye and leg movements during sleep.
  • Epworth Sleepiness Scale (ESS): A questionnaire used to measure daytime sleepiness in patients with sleep disorders.
  • Mucolytic: A type of medication that helps break down and thin mucus, making it easier to clear from the airways.
  • AXAHALER: The specific dry powder inhaler device used to administer Nacystelyn in the clinical trial.

References

  1. http://clinicaltrials.eu/trial/56674/