Asthmatic Patients and Control GroupNCT01999855
Frequency of Dysphonia in Asthmatic Patients
A study testing Phoniatric tests in people with Asthmatic Patients and Control Group, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests. The etiology of dysphonia in asthmatic remains controversial. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asthmatic Patients and Control Group
- What is being tested?
- Phoniatric tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Dec 2017
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Aged between 18 to 65 years
- Patient who signed the informed consent.
- affiliated with a social security system.
- Patients with asthma (GINA criteria)
- persistent asthma with inhaled corticosteroids.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de pneumologie, d'allergologie et de pathologie de l'environnement
Strasbourg, 67091
About this study
Official title: Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients
For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.
The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time, inhaled corticosteroids have been considered as responsible for organic abnormalities of the vocal cords. We hypothesized that women with asthma have more often dysphonia, and that dysphonia is rather functional origin.
- Conditions
- Asthmatic Patients and Control Group
- Being tested
- Phoniatric tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phoniatric testsOther
Also called - the Phonatory Maximum Time, - Vocal Handicap Index, - Scale GRBAS of Hirano, - Videolaryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | * the Phonatory Maximum Time
* Vocal Handicap Index
* Scale GRBAS of Hirano
* Videolaryngoscopy Receives: Other: Phoniatric tests |
| Asthmatic patients | Experimental | * The Phonatory Maximum Time
* Vocal Handicap Index
* Scale GRBAS of Hirano
* Videolaryngoscopy Receives: Other: Phoniatric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal
Measured: Four week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2015
- Study completionDec 2017
Why it stopped: technical problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthmatic Patients and Control GroupStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric De Blay, Pr, Principal investigator, Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999855
- Sponsor's protocol ID
- 5517
- Status last verified
- Sep 2017
- First submitted
- 25 Nov 2013
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT01999855
- Acronym / sponsor ID
- 5517
- Conditions
- Asthmatic Patients and Control Group
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: technical problem
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Dec 2013 (estimated)
- 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.
For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests.
The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time, inhaled corticosteroids have been considered as responsible for organic abnormalities of the vocal cords. We hypothesized that women with asthma have more often dysphonia, and that dysphonia is rather functional origin.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Phoniatric tests* the Phonatory Maximum Time * Vocal Handicap Index * Scale GRBAS of Hirano * Videolaryngoscopy |
| Asthmatic patients | Experimental | Other: Phoniatric tests* The Phonatory Maximum Time * Vocal Handicap Index * Scale GRBAS of Hirano * Videolaryngoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- Aged between 18 to 65 years
- Patient who signed the informed consent.
- affiliated with a social security system.
- Patients with asthma (GINA criteria)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Phoniatric testsAlso: - the Phonatory Maximum Time, - Vocal Handicap Index, - Scale GRBAS of Hirano, - Videolaryngoscopy | Other | Asthmatic patients, control group |
Primary outcome
Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal
Time frame: Four week
Results and safety
The study was stopped early (reason given: technical problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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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.
Frédéric De Blay, Pr principal investigator
Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phoniatric tests in people with Asthmatic Patients and Control Group, run by University Hospital, Strasbourg, France 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 6 inclusion and 0 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 27 Aug 2018. 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: technical problem). 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?
Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal (time frame: Four week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2018.