Effect of NAL in participants with sleep disorders

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratoires S.M.B.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

1 Jul 2024 → 5 Mar 2026

Decision date (initial)

2024-05-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The objective of the study is to assess if Nacystelyn (NAL) Dry-Powder Inhaler (DPI) can be beneficial in the treatment of obstructive sleep apnea (OSA)

Secondary objectives 2

1. To assess the efficacy of NAL DPI, as antioxidant, on the oxidative stress induced by the obstructive sleep apnea.
2. To assess the overall safety of the NAL DPI

Conditions and MedDRA coding

Obstructive Sleep Apnea

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Adult individual with obstructive sleep apnea
2. Apnea-hypopnoea index (AHI) ≥15/h and <30/h
3. Individual naïve to CPAP or not treated by CPAP for at least two months
4. Oxygen desaturation index ≥10
5. BMI between 18 and 35.0 kg/m2, inclusive
6. If a woman of childbearing potential (WOCBP), the individual must agree to practice the protocol specified contraception. If female and of non-childbearing potential, the individual must be either postmenopausal (defined as age ≥ 55 years with no menses for 12 or more months without an alternative medical cause) or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
7. Individual voluntarily agrees to participate in this clinical trial and signs an approved informed consent prior to performing any of the Screening Visit procedures.
8. Individual must be able to understand the nature of the clinical trial and must have the opportunity to have any questions answered.

Exclusion criteria 16

1. Clinically significant craniofacial malformation.
2. Participant presenting another clinically significant concomitant disease states that would interfere with the patient’s participation in the study or confound study interpretation.
3. Participants presenting a hypersensitivity to the active substance (acetylcysteine), other chemically similar substances (e.g. carbocisteine or erdosteine) or to the excipient mannitol.
4. Use of antitussives.
5. Drug or alcohol abuse.
6. Participant with inability to use a smartphone or impossibility to shave the beard
7. Women who are pregnant or nursing.
8. Clinically significant unstable cardiac disease and individuals presenting heart failure with an ejection fraction inferior to 40%.
9. Participants presenting COPD (Tiffeneau index (FEV1/FVC) <0.7) or asthma.
10. Participant who had a previous surgery for OSA within 4 weeks before screening.
11. Participant with compromised mucociliary function (e.g. bronchiectasis).
12. A significant infection of upper respiratory airways requiring medical treatment in the past 30 days.
13. Use of steroidal and non-steroidal anti-inflammatory drugs, antioxidants or other medications that lower oxidative stress.
14. Use of cardiovascular medications, not stabilized for at least 3 months.
15. Use of drugs that impair sleep (hypnotics, sedatives, anxiolytics, melatonin, morphinics and derivatives which may influence sleep, central nervous stimulants)
16. Participants showing bronchial hyperresponsiveness to inhaled mannitol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint will be the mean change in Apnea-Hypopnea Index (PSG-AHI3%) from baseline to 6 weeks of treatment.

Secondary endpoints 22

1. Absolute change in the mandibular movement respiratory disturbance index (MM-RDI) from baseline to week 6
2. Absolute change in the mandibular movement respiratory effort (MM-RE) from baseline to week 6
3. Absolute change in apnea-hypopnea index (AHI) measured by Sunrise® from baseline to week 6
4. Absolute change in the number of apnea episodes from baseline to week 6
5. Absolute change in the number of hypopnoea episodes from baseline to week 6
6. Absolute change in the longest apnoeic episode duration from baseline to week 6
7. Absolute change in the oxygen desaturation index (ODI) from baseline to week 6
8. Absolute change in the time under 90% oxygen saturation (T90%) from baseline to week 6
9. Absolute change in the mean arterial oxygen saturation (MSaO2) from baseline to week 6
10. Absolute change in the lowest arterial oxygen saturation (LSaO2) from baseline to week 6
11. Absolute change in the pulse wave amplitude drops (PWADs) index from baseline to week 6
12. Absolute change in the relative snore time from baseline to week 6
13. Absolute change in the number of snore episodes from baseline to week 6
14. Absolute change in the longest snoring episode from baseline to week 6
15. Absolute change in the Epworth sleepiness score (ESS) from baseline to week 6
16. Absolute change in the participant-reported score of nasal obstruction symptom evaluation (NOSE) questionnaire from baseline to week 6
17. Absolute change in the participant-reported score from Pichot’s fatigue scale from baseline to week 6
18. Absolute change in the participant-reported score from Patient Health Questionnaire (PHQ-9) from baseline to week 6
19. Absolute change in oxidative stress and inflammation biomarkers from baseline to week 6.
20. Adverse events, vital signs, physical examination and Concomitant medication use
21. Absolute change in PSG-AHI4% from baseline to 6 weeks of treatment
22. Absolute change in the Total sleep time (TST) from baseline to week 6

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratoires S.M.B.

Sponsor organisation

Laboratoires S.M.B.

Address

Rue de la Pastorale 26-28

City

Molenbeek-Saint-Jean

Postcode

1080

Country

Belgium

Scientific contact point

Organisation

Laboratoires S.M.B.

Contact name

Sophie De Niet

Public contact point

Organisation

Laboratoires S.M.B.

Contact name

Sophie De Niet

Third parties 6

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications