Frequency of Dysphonia in Asthmatic Patients

Asthmatic Patients and Control Group Clinical Trial

Official title:

Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01999855
• Other study ID #: 5517
• Status: Terminated
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• Est. completion date: December 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthmatic Patients and Control Group
• Dysphonia

Intervention

Other:
• Phoniatric tests

Locations

Country	Name	City	State
France	Service de pneumologie, d'allergologie et de pathologie de l'environnement	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Four week