Frequency of Dysphonia in Asthmatic Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01999855
First received: November 25, 2013
Last updated: December 3, 2013
Last verified: November 2013
  Purpose

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 Intervention
Asthmatic Patients and Control Group
Other: Phoniatric tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

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 [ Time Frame: Four week ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999855

Contacts
Contact: Frédéric De Blay 03.69.55.06.39 frederic.deblay@chru-strasbourg.fr

Locations
France
Service de pneumologie, d'allergologie et de pathologie de l'environnement Not yet recruiting
Strasbourg, France, 67091
Contact: Frédéric De Blay, Pr    03.69.55.06.39    frederic.deblay@chru-strasbourg.fr   
Sub-Investigator: Philippe SCHULTZ, Md PhD         
Sub-Investigator: Cindy Barnig, MD         
Sub-Investigator: Elisabeth PERI, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Frédéric De Blay, Pr Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01999855     History of Changes
Other Study ID Numbers: 5517
Study First Received: November 25, 2013
Last Updated: December 3, 2013
Health Authority: France: ANSM

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

ClinicalTrials.gov processed this record on July 23, 2014