Olfactory DisordersSCLEROLFNCT04178616
Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
A study testing olfactory testing with specific odorants (localisation and identification) in people with Olfactory Disorders and Scleroderma, run by University Hospital, Lille at 1 site in France.
Trial summary
Prospective monocentric study of patients with systemic sclerosis disease. The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfactory Disorders, Scleroderma
- What is being tested?
- olfactory testing with specific odorants (localisation and identification)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 31 Dec 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and/or women
- With systemic sclerosis disease
- Patient willing to comply with all procedures of the study and its duration
- Social insured patients
Who cannot join
- Patient with medical history of chronic rhinosinusitis (CRS), previously known for olfactory disorders secondary to another etiology (skull base trauma, viral rhinosinusitis)
- Past history of sinonasal surgery
- Patient unable to receive informed information
- Refusal to sign the consent form
- Unwillingness or inability to follow the study procedures, in the opinion of the investigator
- Person deprived of the liberty
- Non-coverage by the social security insurance
- Person benefiting from a system of legal protection (guardianship…)
Trial locations and contacts
1 site in 1 country.
About this study
Prospective monocentric study of patients with systemic sclerosis disease.
The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease.
The secondary outcomes are:
- To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients.
- To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease
- Conditions
- Olfactory Disorders, Scleroderma
- Being tested
- olfactory testing with specific odorants (localisation and identification)
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory testing with specific odorants (localisation and identification)Diagnostic test
Also called nasofibroscopy to identify sinonasal mucosa diseases
Olfactory testing : ETOC (European Test of Olfactory capabilities)
| Study group | Role | What they receive |
|---|---|---|
| systemic sclerosis patients population | Other | All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study. Receives: Diagnostic Test: olfactory testing with specific odorants (localisation and identification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points
The European Test of Olfactory Capabilities is an olfactory test based on standardized odorants.A composite score evaluates the ability of the patients to define odors localisation and odors identification.The maximum global score is 32 points, the minimum is 0 point. The localisation ability score is rated from 0 to 16 points; The identification score is rated from 0 to 16 points. An hyposmia is defined by a global score strictly inferior to 27 points.
Measured: once time, Baseline
Secondary outcomes (8)
Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points
The European Test of Olfactory Capabilities is an olfactory test based on standardized odorants. A composite score evaluates the ability of the patients to define odors localisation and odors identification. The maximum global score is 32 points, the minimum is 0 point. The localisation ability score is rated from 0 to 16 points; The identification score is rated from 0 to 16 points. An anosmia is defined by an global score strictly inferior to 10 points.
Measured: once time, Baseline
Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.
Evaluation of nasal mucosa inflammation status is based on Lund-Kennedy endoscopic score. The Lund Kennedy score ranged from 0 to 8 points for each nasal fossa. It evaluates oedema, discharge, the presence of polyps and crusting, that can be seen through nasal fibroscopy. A score strictly under 3 points on each side is considered as non pathologic whereas a score equal or over 3 points on each side is pathological. A higher score means a worse outcome.
Measured: once time, Baseline
Measurement of systemic sclerosis disease activity with Medsger Score
Medsger Score estimates disease involvement of each organ (heart, vessels, skin, brain, kidney, gut, muscle, joint and loss of weight,) ranging from 0 to 4 (0: normal, 1: mild, 2: moderate, 3: severe, 4: terminal). The score ranges from 0 to 36 points.A higher score means a worse outcome.
Measured: once time, Baseline
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score
The ETOC score ranges from 0 to 32 points ( as previously described ).A higher score means a better outcome.
Medsger score ranges from 0 to 36 points. A higher score means a worse outcome.
Measured: once time, Baseline
Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.
The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome.
The Rodnan score measured skin thickness (0 : normal, 1 : mild, 2: moderate, 3: severe) on 17 different sites. A global score between 0 point to 51 points is established.A higher score means a worse outcome
Measured: once time, Baseline
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score
The ETOC score ranges from 0 to 32 points (as previously described ). A higher score means a better outcome.
The Health Assessment Questionnaire is based on 20 questions related to routine activities with a grading system ranging from 0 to 3 (0: no difficulty, 1: moderate difficulty, 2: severe difficulty, 3: total incapacity). A global score between 0 point to 60 points is established. a higher HAQ score means a worse outcome
Measured: once time, Baseline
Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22)
The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome.
The sinonasal outcome test 22 is based on 22 questions with a grading from 0 to 5 ( 0: no probem, 1: very mild problem, 2: mild problem, 3: moderate problem, 4: severe problem, 5: very severe problem). A global score between 0 and 110 points is measured. A higher score means a worse outcome.
Measured: once time, Baseline
Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale.
The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome.
The Hospital anxiety and Depression (HAD) scale is based on 14 questions with a grading system ranging from 0 to 3. A global score between 0 and 42 is measured. A higher score means a worse outcome.
Measured: once time, Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start31 Dec 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: Following the COVID-related health crisis, nasofibroscopic sampling could no longer be carried out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Olfactory DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is single-group epidemiologic study, without any control group.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Launay, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178616
- Sponsor's protocol ID
- 2018_84
- Other IDs
- 2019-A01083-54
- Acronym
- SCLEROLF
- Status last verified
- Nov 2020
- First submitted
- 30 Sep 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amital H, Agmon-Levin N, Shoenfeld N, Arnson Y, Amital D, Langevitz P, Balbir Gurman A, Shoenfeld Y. Olfactory impairment in patients with the fibromyalgia syndrome and systemic sclerosis. Immunol Res. 2014 Dec;60(2-3):201-7. doi: 10.1007/s12026-014-8573-5.
PubMed 25424576Bombini MF, Peres FA, Lapa AT, Sinicato NA, Quental BR, Pincelli ASM, Amaral TN, Gomes CC, Del Rio AP, Marques-Neto JF, Costallat LTL, Fernandes PT, Cendes F, Rittner L, Appenzeller S. Olfactory function in systemic lupus erythematosus and systemic sclerosis. A longitudinal study and review of the literature. Autoimmun Rev. 2018 Apr;17(4):405-412. doi: 10.1016/j.autrev.2018.02.002. Epub 2018 Feb 11.
PubMed 29444467
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
- ClinicalTrials.gov ID
- NCT04178616
- Acronym / sponsor ID
- SCLEROLF / 2018_84
- Conditions
- Olfactory Disorders, Scleroderma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the COVID-related health crisis, nasofibroscopic sampling could no longer be carried out
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective monocentric study of patients with systemic sclerosis disease.
The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease.
The secondary outcomes are:
- To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients.
- To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is single-group epidemiologic study, without any control group.
| Arm | Type | Receives |
|---|---|---|
| systemic sclerosis patients population | Other | Diagnostic Test: olfactory testing with specific odorants (localisation and identification)All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and/or women
- With systemic sclerosis disease
- Patient willing to comply with all procedures of the study and its duration
- Social insured patients
Key exclusion criteria (8 listed)
- Patient with medical history of chronic rhinosinusitis (CRS), previously known for olfactory disorders secondary to another etiology (skull base trauma, viral rhinosinusitis)
- Past history of sinonasal surgery
- Patient unable to receive informed information
- Refusal to sign the consent form
- Unwillingness or inability to follow the study procedures, in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory testing with specific odorants (localisation and identification)Also: nasofibroscopy to identify sinonasal mucosa diseasesOlfactory testing : ETOC (European Test of Olfactory capabilities) | Diagnostic test | systemic sclerosis patients population |
Primary outcome
Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points
Time frame: once time, Baseline
The European Test of Olfactory Capabilities is an olfactory test based on standardized odorants.A composite score evaluates the ability of the patients to define odors localisation and odors identification.The maximum global score is 32 points, the minimum is 0 point. The localisation ability score is rated from 0 to 16 points; The identification score is rated from 0 to 16 points. An hyposmia is defined by a global score strictly inferior to 27 points.
8 secondary outcomes
Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points
Time frame: once time, Baseline
Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.
Time frame: once time, Baseline
Measurement of systemic sclerosis disease activity with Medsger Score
Time frame: once time, Baseline
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score
Time frame: once time, Baseline
Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.
Time frame: once time, Baseline
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score
Time frame: once time, Baseline
Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22)
Time frame: once time, Baseline
Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale.
Time frame: once time, Baseline
Results and safety
The study was stopped early (reason given: Following the COVID-related health crisis, nasofibroscopic sampling could no longer be carried out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Background: PubMed 25424576Amital H, Agmon-Levin N, Shoenfeld N, Arnson Y, Amital D, Langevitz P, Balbir Gurman A, Shoenfeld Y. Olfactory impairment in patients with the fibromyalgia syndrome and systemic sclerosis. Immunol Res. 2014 Dec;60(2-3):201-7. doi: 10.1007/s12026-014-8573-5.
- Results publication: PubMed 29444467Bombini MF, Peres FA, Lapa AT, Sinicato NA, Quental BR, Pincelli ASM, Amaral TN, Gomes CC, Del Rio AP, Marques-Neto JF, Costallat LTL, Fernandes PT, Cendes F, Rittner L, Appenzeller S. Olfactory function in systemic lupus erythematosus and systemic sclerosis. A longitudinal study and review of the literature. Autoimmun Rev. 2018 Apr;17(4):405-412. doi: 10.1016/j.autrev.2018.02.002. Epub 2018 Feb 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Launay, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory testing with specific odorants (localisation and identification) in people with Olfactory Disorders and Scleroderma, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Following the COVID-related health crisis, nasofibroscopic sampling could no longer be carried out). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points (time frame: once time, Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.