Corticosteroid in treatment of acute laryngitis among vocal professionals

2024-512192-12-00 Phase III and Phase IV (Integrated) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Authorised, recruitment pending
Participants planned 70
Countries 1
Sites 1

Acute laryngitis

To find out the efficacy of oral corticosteroid therapy compared with placebo in treatment of acute laryngitis among vocal professionals and singers.

Key facts

Sponsor
HUS-Yhtymae
Participant type
Patients, Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Otorhinolaryngologic Diseases [C09]
Decision date (initial)
2024-10-29
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-512192-12-00
EudraCT number
2021-006497-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To find out the efficacy of oral corticosteroid therapy compared with placebo in treatment of acute laryngitis among vocal professionals and singers.

Conditions and MedDRA coding

Acute laryngitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Hoarseness that starts during or after flu symptoms and has lasted for less than three weeks
  2. Fluency in Finnish language
  3. Minimum age of 18 years and maximum age of 64 years
  4. Vocal professionals or those studying to become one

Exclusion criteria 8

  1. hypersensitivity to the prednisolone
  2. Contraindication to prednisolone (tuberculosis, acute psychosis, gastric or duodenal ulcer).
  3. Fungal and/or bacterial laryngitis
  4. Significant voice symptoms before laryngitis
  5. Fever (over 38C)
  6. Pregnancy
  7. Breastfeeding
  8. Simultaneous oral bacterial, viral or fungal medication.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The duration of the vocal symptoms

Secondary endpoints 1

  1. Inflammatory findings of larynx (especially in vocal cords) in laryngoscopy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Prednisolon 20 mg tabletit

PRD9355724 · Product

Active substance
Prednisolone
Substance synonyms
(8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
140 mg milligram(s)
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
H02AB06 — PREDNISOLONE
Marketing authorisation
12104
MA holder
ORIFARM HEALTHCARE A/S
MA country
Finland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

White, flat round, uncoated tablet. Diameter 9 mm.

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

HUS-Yhtymae

30 Total trials 12 Recruiting 5 Ended
Academic / Non-commercial
Sponsor organisation
HUS-Yhtymae
Address
Stenbackinkatu 9
City
Helsinki
Postcode
00290
Country
Finland

Scientific contact point

Organisation
HUS-Yhtymae
Contact name
Korvaklinikka, foniatrian poliklinikka

Public contact point

Organisation
HUS-Yhtymae
Contact name
Korvaklinikka, foniatrian poliklinikka

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Finland Authorised, recruitment pending 70 1
Rest of world — 0 —

Investigational sites

Finland

1 site · Authorised, recruitment pending
HUS-Yhtymae
Department of Phoniatrics, Helsinki University Hospital, Stenbackinkatu 9, 00290, Helsinki

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Tutkimussuunnitelma kortisoni lopullinen 17102024 1
Recruitment arrangements (for publication) Transition trial 1
Subject information and informed consent form (for publication) Suostumusasiakirjat 1
Summary of Product Characteristics (SmPC) (for publication) Prednisolon valmisteyhteenveto 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-17 Finland Acceptable
2024-10-29
 2024-10-29