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Frequency of Dysphonia in Asthmatic Patients

Primary Purpose

Asthmatic Patients and Control Group

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phoniatric tests
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthmatic Patients and Control Group

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Sites / Locations

  • Service de pneumologie, d'allergologie et de pathologie de l'environnement

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

Asthmatic patients

Arm Description

the Phonatory Maximum Time Vocal Handicap Index Scale GRBAS of Hirano Videolaryngoscopy

The Phonatory Maximum Time Vocal Handicap Index Scale GRBAS of Hirano Videolaryngoscopy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 25, 2013
Last Updated
August 24, 2018
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01999855
Brief Title
Frequency of Dysphonia in Asthmatic Patients
Official Title
Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
technical problem
Study Start Date
December 2013 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthmatic Patients and Control Group

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
the Phonatory Maximum Time Vocal Handicap Index Scale GRBAS of Hirano Videolaryngoscopy
Arm Title
Asthmatic patients
Arm Type
Experimental
Arm Description
The Phonatory Maximum Time Vocal Handicap Index Scale GRBAS of Hirano Videolaryngoscopy
Intervention Type
Other
Intervention Name(s)
Phoniatric tests
Other Intervention Name(s)
- the Phonatory Maximum Time, - Vocal Handicap Index, - Scale GRBAS of Hirano, - Videolaryngoscopy
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric De Blay, Pr
Organizational Affiliation
Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de pneumologie, d'allergologie et de pathologie de l'environnement
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

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Frequency of Dysphonia in Asthmatic Patients

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