E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obstructive Sleep Apnoea Syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Collapse of the upper parts of the airway and throat during sleep leading to poor quality and disrupted sleep |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029983 |
E.1.2 | Term | Obstructive sleep apnoea syndrome |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028735 |
E.1.2 | Term | Nasal congestion |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the effect of Xylometazoline versus placebo on the time to return of Obstructive Sleep Apnoea (OSA) in patients with mild to moderate OSA following withdrawal of CPAP therapy |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of Xylometazoline versus placebo on subjective daytime sleepiness in patients with moderate OSA following withdrawal of CPAP therapy.
To assess the effect of Xylometazoline versus placebo on sleep fragmentation in patients with moderate OSA following withdrawal of CPAP therapy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Participant is willing and able to give informed consent for participation in the trial. 2. Male or Female, aged 18 years or above. 3. Diagnosed with proven obstructive sleep apnoea, with an ODI > 15 and < 30 on original diagnostic sleep study. 4. Established on CPAP treatment for > 3 months with mean usage of > 4 hours/ night for last 3 months 5. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 6. Willing to withdraw from CPAP treatment for 28 days 7. Good mobile phone reception 8. Use of Wi-Fi at home |
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E.4 | Principal exclusion criteria |
1. Significant renal or hepatic impairment. 2. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. 3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. 4. Participants who have participated in another research trial involving an investigational product in the past 12 weeks. 5. Professional driver or, as assessed by the local investigator, any other vigilance critical activity. 6. Daytime SaO2 <93%, or any prior arterial blood gas performed on air showing PaO2 <8.0 kPa or PaCO2 > 6.0, significant hypoventilation on diagnostic sleep study mean saturation <92% 7. Previous or current history of central sleep apnoea or Cheyne-Stokes respiration. 8. Previous history of a sleepiness-related accident. 9. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 10. Participants with a fructose intolerance |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the number of days to return of obstructive sleep apnoea on overnight pulse oximetry (oxygen desaturation index >15 on 3 consecutive nights) or until patient is unwilling to continue without CPAP and restarts their device. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Maximum treatment duration 28 days, or sooner if overnight oximetry shows return of obstructive sleep apnoea (oxygen desaturation index >15 on 3 consecutive nights). |
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E.5.2 | Secondary end point(s) |
1. To assess the effect of Xylometazoline versus placebo on subjective daytime sleepiness in patients with moderate OSA following withdrawal of CPAP therapy
2. To assess the effect of Xylometazoline versus placebo on sleep fragmentation in patients with moderate OSA following withdrawal of CPAP therapy
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Patient reported sleepiness on Epworth Sleepiness Score at baseline, and weekly (day 0, 7, 14, 21 and 28) until 35 days
2. Overnight pulse oximetry during withdrawal of CPAP, (maximum 28 days) to assess pulse rate variability |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is the date the last participant’s seven day e-diary card has been returned. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |