E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Nasal airway obstruction due to a twist in the wall (partition) that separates your two nostrils |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
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 | 10034383 |
E.1.2 | Term | Perennial rhinitis |
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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
E.1.2 | System Organ Class | 100000004870 |
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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 | 10028756 |
E.1.2 | Term | Nasal polyps |
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 establish, and inform guidance for, the best management strategy for participants with nasal obstruction associated with a deviated septum via a randomised controlled trial: a. To compare clinical and cost effectiveness over a complete duration of 6 months in adults with nasal septal deviation between nasal septoplasty +/- contralateral turbinate reduction and medical management. b. To apply NAIROS level I evidence to inform NHS guidance.
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E.2.2 | Secondary objectives of the trial |
To measure clinical effectiveness according to: i. Subjective self-report rating of nasal airway obstruction (NOSE scale and DOASS (Double Ordinal Airway Severity Score). ii. Heterogeneity of estimated treatment effect specifically according to severity of obstruction and gender. iii. Objective measures of nasal patency (peak nasal inspiratory flow rate and nasal partitioning ratio). iv. Quality-of-life as recorded by SF36. v. Safety profile recording the number of adverse events and additional interventions required.
To adjust the estimate of effectiveness in the light of other baseline covariates - severity of self-reported nasal block (NOSE), gender and concomitant turbinate reduction.
To use the results in the surgical arm to explore a possible definition of technical failure in experienced hands .i.e. experienced surgeons, either consultants or non-consultant career clinicians, but not trainee otolaryngologists.
To assess to what extent trial participants are representative of |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A qualitative recruitment intervention sub-study is embedded within the trial protocol with specific objective to optimise patient recruitment. This is to be accomplished through the identification of barriers to recruitment through interviews with participants and clinicians. |
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E.3 | Principal inclusion criteria |
• Adults aged ≥ 18 years • Baseline NOSE score ≥30 • Septal Deflection at baseline visible on examination via nasoendoscopy • Capacity to provide informed written consent and complete the trial questionnaires Participants are willing and able to provide full written informed consent
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E.4 | Principal exclusion criteria |
• Any prior septal surgery • Systemic inflammatory disease or current oral steroid treatment • Granulomatosis with polyangiitis • Naso-endoscopic evidence of unrelated associated pathology e.g. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the of polyposis or pus • Any intranasal recreational drug use • Breast feeding, pregnancy or intended pregnancy for duration of involvement in the trial • Bleeding diathesis • Therapeutic anticoagulation (Warfarin/NOAC therapy) • Clinically significant contraindication to general anaesthesia • Patients known to be immuno-compromised
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E.5 End points |
E.5.1 | Primary end point(s) |
Sino-Nasal Outcome Test 22 (SNOT-22) score. A validated PROM (patient reported outcome measure) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary outcome measure taken at 6 months post-randomisation. Repeated at 12 months. |
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E.5.2 | Secondary end point(s) |
SNOT-22 subscales (Rhinologic, Sleep, Ear/facial pain, Psychological)
Nasal Obstruction Symptom Evaluation (NOSE) score a validated patient reported outcome measure of nasal obstruction
Safety measures: Number and characteristics of any adverse events and surgical complication/ failure and re-intervention
SF-36, further converted into QALYs using SF-6D Algorithm 129 longitudinally
Use of and timing of additional interventions in primary and secondary care recorded at 6-months and 12-months
Number of days unable to undertake usual activities recorded by Health Care Utilisation Questionnaire
Health Economic Outcomes Incremental cost per Change in SNOT-22 QALY gained (based on responses to SF-36) Adverse Event avoided Costs to NHS and participants at 12 months Longer term economic model to assess costs and health consequences beyond 12 month follow-up period
Qualitative Outcomes Observations of training and NAIROS meetings Interviews with health professionals and participants Audio-recording of recruitment discussions
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
SNOT-22 at 12 months
NOSE scale at baseline, 6 months and 12 months
Adverse events and surgical complications/failure and re-intervention within 12 months
SF-36, converted to QALY at baseline, 6 months and 12 months
Use of and timing of additional interventions in primary and secondary care at 6 and 12 months |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The surgical procedure: septoplasty |
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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 | 17 |
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 the trial is defined as the conclusion of the last patient’s last visit (i.e. the 12 month visit of the final patient recruited to the trial). |
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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 | 11 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 31 |