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Frequency of Dysphonia in Asthmatic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01999855
Recruitment Status : Terminated (technical problem)
First Posted : December 3, 2013
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Asthmatic Patients and Control Group Other: Phoniatric tests

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients
Actual Study Start Date : December 2013
Primary Completion Date : September 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: control group
  • the Phonatory Maximum Time
  • Vocal Handicap Index
  • Scale GRBAS of Hirano
  • Videolaryngoscopy
Other: Phoniatric tests
Other Names:
  • - the Phonatory Maximum Time
  • - Vocal Handicap Index
  • - Scale GRBAS of Hirano
  • - Videolaryngoscopy
Experimental: Asthmatic patients
  • The Phonatory Maximum Time
  • Vocal Handicap Index
  • Scale GRBAS of Hirano
  • Videolaryngoscopy
Other: Phoniatric tests
Other Names:
  • - the Phonatory Maximum Time
  • - Vocal Handicap Index
  • - Scale GRBAS of Hirano
  • - Videolaryngoscopy


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999855


Locations
France
Service de pneumologie, d'allergologie et de pathologie de l'environnement
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Frédéric De Blay, Pr Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01999855     History of Changes
Other Study ID Numbers: 5517
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Asthma
Dysphonia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Voice Disorders
Laryngeal Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms