Clinical Trials Register

Summary
EudraCT Number:	2015-002796-23
Sponsor's Protocol Code Number:	RHINO-CZ-2015-01
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-07-09
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2015-002796-23

A.3

Full title of the trial

Multicenter, parallel, randomized, single-blind trial comparing the efficacy and tolerability of Rhinaction®, an osmotic decongestant nasal spray containing essential oils versus Olynth® 0.1%, a vasoconstrictor, in the relief of acute rhinitis symptoms in adults.

Multicentrická, paralelní, randomizovaná, jednoduše zaslepená studie, srovnávající účinnost a snášenlivost Rhinaction®, osmotického dekongescenčního nosního spreje s obsahem esenciálních olejů, oproti Olynth® 0.1%, vazokonstrikčního nosního spreje sloužícího k úlevě od příznaků akutní rýmy u dospělých.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

RHINO

A.4.1

Sponsor's protocol code number

RHINO-CZ-2015-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Laboratoire de la Mer
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Laboratoire de la Mer
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Leading Clinical Research, s.r.o.
B.5.2	Functional name of contact point	Managing Director
B.5.3	Address:
B.5.3.1	Street Address	Jana Zajíce 216/29
B.5.3.2	Town/ city	Prague 7
B.5.3.3	Post code	17000
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	00420226 807 053
B.5.5	Fax number	00420226 013 050
B.5.6	E-mail	Jiri.Paseka@clinical-research.cz

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Olynth® 0.1%
D.2.1.1.2	Name of the Marketing Authorisation holder	McNeil Products Limited,c/o Johnson & Johnson,Maidenhead, Berkshire
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Olynth® 0.1%
D.3.4	Pharmaceutical form	Nasal spray
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Xylometazolini hydrochloridum 0,010g
D.3.9.1	CAS number	0000526-36-3
D.3.9.3	Other descriptive name	XYLOMETAZOLINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB05152MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute rhinitis
Adults aged ≥18years old suffering from acute rhinitis with symptoms present for up to 72h.
The purpose of this study is to demonstrate the efficacy and compare safety and tolerability of Medical Device class I Rhinaction® as well as its non-inferiority when compared to Medical Product Olynth® 0.1% in cases of acute rhinitis in adults up to 8 days of administration

Akutni ryma,
Dospělí (muži a ženy) ve věku ≥18 let, s příznaky nachlazení přítomné po dobu kratší než 72 hodin.
Cílem tohoto klinického hodnocení je vyhodnotit účinnost a porovnat snášenlivost a bezpečnost léčby zdravotnickým prostředkem třídy I Rhinaction® s přípravkem Olynth® 0,1% u dospělých pacientů s akutní rýmou po dobu jejich onemocnění, maximálně však po dobu 8 dnů.

E.1.1.1

Medical condition in easily understood language

Acute rhinitis
Patients with symptoms of common cold presented for less than 72 hours.

Akutni ryma,
Dospělí s příznaky nachlazení přítomné po dobu kratší než 72 hodin

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demonstrate the non-inferiority of Medical Device class I Rhinaction®, an osmotic decongestant nasal spray containing essential oils compared to Medical Product Olynth® 0.1%, a vasoactive substance in acute rhinitis symptoms relief.

Prokázat noninferioritu (hodnocení, který ukazuje, že nová léčba je srovnatelná se standardní léčbou) zdravotnického prostředku třídy I Rhinaction®, osmotického dekongescenčního nosního spreje s obsahem esenciálních olejů ve srovnání s vazoaktivní látkou Olynth® 0,1% od příznaků akutní rýmy.

E.2.2

Secondary objectives of the trial

Assess:
• Tolerability
• Safety
• Impact on Quality of Life
• Effect on illness severity
• Onset of action
• Lasting effect
• Product acceptability (adherence)
• Overall satisfaction

Vedlejšími cíli tohoto klinického hodnocení je vyhodnotit:
• snášenlivost,
• bezpečnost,
• dopad na kvalitu života,
• vliv na závažnost onemocnění,
• nástup účinku,
• trvání účinku,
• přijatelnost léku (dodržování léčby),
• celkovou spokojenost s léčbou

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Adults (male or female) aged ≥18years old.
•Willingness to provide written informed consent prior to performance of any study-related procedure.
•Diagnosis of common cold: Jackson score of two (2) or higher; symptoms severity rated as 0=absent, 1=mild, 2=moderate, and 3=severe for each of the 8 Jackson symptoms: sneezing, nasal discharge, nasal obstruction, sore throat, cough, headache, malaise and chilliness. At least one (1) of the first four cold-specific Jackson symptoms is required on the day of screening (=randomization).
•Symptoms expressed for up to 72 hours prior to the screening visit.
•Negative urine pregnancy test in women of childbearing potential.
•Topical vasoactive (for ex. Nasivin, Sanorin etc.) and antiseptic substances (for ex. Pinosol) can be used before the trial, no washout period is needed.
•Subjects agreeing to stop current use of topical vasoactive and/or topical antiseptic substances at randomization.
•Subjects not participating in any other clinical trial.
•Subjects screened only once in this clinical trial.

•Dospělí (muži a ženy) ve věku ≥18 let.
•Ochota poskytnout písemný informovaný souhlas před provedením jakéhokoliv výkonu v souvislosti s klinickým hodnocením.
•Diagnóza nachlazení: Jacksonovo skóre musí být rovno 2 nebo vyšší, se závažností příznaků hodnocenou jako: 0=chybějící, 1=mírné, 2=středně závažné a 3=závažné, a to pro každý z 8 příznaků podle Jacksona: kýchání, sekrece z nosu, ucpaný nos, bolest v krku, kašel, bolest hlavy, nevolnost a zimnice. Požaduje se výskyt alespoň jednoho z prvních čtyř příznaků specifických pro nachlazení podle Jacksona.
•Příznaky nachlazení přítomné po dobu kratší než 72 hodin.
•Negativní těhotenský test z moči u fertilních žen.
•Pacient může používat topické vazoaktivní látky (např. Nasivin, Sanorin) a antiseptické látky (např. Pinosol); wash-out perioda není nutná.
•Přičemž pacient souhlasí s tím, že doposud používané topicke vazoaktivní a/nebo topicke antiseptické látky při randomizaci vysadí.
•Pacient se ve stejné době neúčastní žádného jiného klinického hodnocení.
•Pacient, může být zařazen do tohoto hodnocení pouze jednou.

E.4

Principal exclusion criteria

•Current or past history of allergy combined with eye/nose itching or sneezing (such as allergic rhinitis).
•Current or past history of asthma bronchiale with cough, wheezing or shortness of breath.
•Prospective participants or enrollers feeling that any current symptoms are due to allergy, asthma or other non-URI cause.
•Other inflammatory disease than common cold.
•Secondary infection such as purulent acute otitis media and/or acute bacterial rhinosinusitis and/or lower respiratory tract bacterial infection.
•Known immunodeficiency.
•Symptoms of common cold present for more than 72 hours.
•Subjects with contraindication to vasoactive treatment.
•Known allergy to essential oils.
•Use of other cold medicine prior to inclusion (except topical vasoactives and/or topical antiseptics that will be discontinued):
- topical and/or inhaled antihistaminics, corticoids and antibiotics before inclusion are forbidden;
- per os taken vasoactives, antihistaminics, corticoids and antibiotics before inclusion are forbidden.
•Presence of chronic disease that may interfere with cold treatment and/or symptoms reporting (such as chronic rhinosinusitis).
•Pregnant and breastfeeding women.

•Alergie kombinovaná se svěděním v nose či kýcháním (jako je senná rýma) v současné době nebo v anamnéze.
•Astma bronchiale s kašlem, sípotem nebo dušností v současné době nebo v anamnéze.
•Zájemce o účast nebo zařazovaný účastník, který se domnívá, že kterékoliv stávající příznaky jsou způsobeny alergií, astmatem nebo ostatními příčinami jinými než infekcí horních cest dýchacích.
•Jiné zánětlivé onemocnění než nachlazení.
•Sekundární infekce, jako je hnisavý akutní zánět středního ucha a / nebo akutní bakteriální rhinosinusitida a / nebo bakteriální infekce dolních cest dýchacích.
•Známá imunitní nedostatečnost.
•Příznaky nachlazení přítomné po dobu delší než 72 hodin.
•Subjekty s kontraindikací týkající se vazoaktivní léčby.
•Užívání jiných léku na nachlazení před zařazením (s výjimkou topických vazoaktivních a/nebo topických antiseptických látek, která budou ukončena):
- topická a/nebo inhalačních antihistaminika, kortikoidy a antibiotika,
- orálně užívané vazoaktivní látky, antihistaminika, kortikoidy a antibiotika.
•Známá alergie na esenciální oleje.
•Přítomnost chronického onemocnění, které by mohlo zasahovat do léčby nachlazení a/nebo hlášení příznaků (jako je například chronická rinosinusitida).
•Těhotné a kojící ženy.

E.5 End points

E.5.1

Primary end point(s)

Area under the curve for the overall severity of cold symptoms score from the Wisconsin Upper Respiratory Symptom Survey (WURSS 21) questionnaire
during the patient illness, but up to the maximum of 8 days of observation.

E.5.1.1

Timepoint(s) of evaluation of this end point

last patient last visit (up to 8 days of patient´s observation)

E.5.2

Secondary end point(s)

Secondary endpoints:
•Individual WURSS-21 items
•WURSS-21 symptoms domains
•WURSS-21 functional impairments domain
•Tolerability (nasal burning, nasal irritation, nasal itching, nasal bleeding (epistaxis), nasal dryness, crusts, bad taste and other are) assessed on a 7-level scale (not at all, very acceptable, acceptable, rather acceptable, rather unacceptable, unacceptable, very unacceptable)
•Product satisfaction (overall satisfaction, overall perceived efficacy, perceived sensation during and after application, willingness to reuse the product if needed, willingness to recommend this product) assessed by 7 level scale questionnaire and acceptability assessed by Morisky questionnaire
•Onset of action and lasting effect assessed by questionnaire

E.5.2.1

Timepoint(s) of evaluation of this end point

last patient last visit (up to 8 days of patient´s observation)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of study is defined by the Last Visit of the Last Patient for RHINO-CZ-2015-01.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

500

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

560

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-09-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-10-07

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials