Clinical Trials Register

Summary
EudraCT Number:	2010-021422-35
Sponsor's Protocol Code Number:	09-NI-EP-001
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-08-13
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2010-021422-35

A.3

Full title of the trial

Efficacy, safety and tolerability of Influcid tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms.
A randomized, international, multicenter, controlled clinical trial.

A.3.2

Name or abbreviated title of the trial where available

INFI (Influcid in Feverish Infections)

A.4.1

Sponsor's protocol code number

09-NI-EP-001

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG
B.1.3.4	Country	Germany
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
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	Nisylen (Tabletten)
D.2.1.1.2	Name of the Marketing Authorisation holder	Deutsche Homöopathie-Union
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Aconitum trit. D3
D.3.9.3	Other descriptive name	ACONITUM
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Bryonia trit. D2
D.3.9.3	Other descriptive name	BRYONIA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Eupatorium perfoliatum trit. D1
D.3.9.3	Other descriptive name	EUPATORIUM PERFOLIATUM
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Gelsemium trit. D3
D.3.9.3	Other descriptive name	GELSEMIUM
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Ipecacuanha trit. D3
D.3.9.3	Other descriptive name	IPECACUANHA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	7723-14-0
D.3.9.2	Current sponsor code	Phosphorus trit. D5
D.3.9.3	Other descriptive name	PHOSPHORUS
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
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)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
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	ben-u-ron Saft
D.2.1.1.2	Name of the Marketing Authorisation holder	bene-Arzneimittel GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Syrup
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PARACETAMOL
D.3.9.1	CAS number	103-90-2
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.IMP: 3
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	Mucosolvan Hustensaft 30 mg/5ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Syrup
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ambroxol
D.3.9.1	CAS number	15942-05-9
D.3.9.3	Other descriptive name	AMBROXOL HYDROCHLORIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.IMP: 4
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	Nasivin ohne Konservierungsstoffe Dosierspray für Erwachsene und Schulkinder
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Selbstmedikation GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Nasal spray, solution
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	OXYMETAZOLINE
D.3.9.1	CAS number	08/02/2315
D.3.9.3	Other descriptive name	oxymetazoline hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.IMP: 5
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	Nasivin ohne Konservierungsstoffe Dosierspray für Kleinkinder
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Selbstmedikation GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Nasal spray, solution
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	OXYMETAZOLINE
D.3.9.1	CAS number	08/02/2315
D.3.9.3	Other descriptive name	oxymetazoline hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.25
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Diagnosed upper respiratory tract infection (URTI) with presence of the following symptoms for equal or less than for 24 hours :
a)Fever (axillary temperature >= 37.5°C) and
b)At least one upper respiratory tract symptom: either
i) one nasal symptom or ii) one pharyngeal symptom or iii) cough and
c) at least one general symptom: either i) feeling tired or ii) weakness or iii) body aches or iv) for children only: irritable / whiny or less active.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10046734
E.1.2	Term	URTI (upper respiratory tract infection)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1. Fraction of patients with symptoms alleviation at day 4 of the study.
Symptoms alleviation is defined as:
- Absence of fever (axillary temperature ≤ 37.2°C) and
- Absence or very mild degree of the symptoms assessed by Wisconsin Upper Respiratory Symptom Survey 21 (WURSS-21).
Fever will be measured 3-times daily by the patient (or in case of children by their parents) at home. Mean value covering last 24 hours will be basis for this definition.
Absence or very mild degree of symptoms is defined as answer to question “How sick do you feel today?” with “0” (not sick) or “1” (very mildly) for both assessments at day 4 (WURSS-21 is filled in twice daily by the patient or in case of children by their parents at home).

E.2.2

Secondary objectives of the trial

2. Time to symptoms alleviation;
3. Fraction of patients with symptoms alleviation as defined for primary objective at study day 2, 3, 5, etc. until end of study as well as fraction of subjects who maintained symptoms alleviation at the different time points (day 3, 4, 5, etc);
4. Time to return to normal daily activity;
5. Time to resolution of individual symptoms (analyzed via WURSS-21);
6. Area under the curve (AUC) describing severity and course of the infection;
7. Total amount, amount per day and duration of Paracetamol, Ambroxol and Oxymetazoline consumption;
8. Fraction of patients who must be withdrawn from the study due to prohibited medication;
9. Treatment outcome according to Integrative Medicine Outcomes Scale (IMOS);
10. Satisfaction with treatment according to Integrative Medicine Patient Satisfaction Scale (IMPSS);
11. Tolerability of treatment;
12. Incidence of complications, adverse events, and adverse drug reactions.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males and females aged from 1 to 65 years;
2. Diagnosed URTI with presence of the following symptoms for equal or less than for 24 hours:
a) Fever (axillary temperature ≥ 37.5°C) and
b) At least one upper respiratory tract symptom: either
i) one nasal symptom (plugged nose, runny nose, sneezing) or
ii) one pharyngeal symptom (scratchy throat, sore throat, pharynx hyperemia) or
iii) cough (ordinary cough without suspicion of acute lower respiratory tract disease) and
c) at least one general symptom: either
i) feeling tired or
ii) weakness or
iii) body aches or
iv) for children only: irritable / whiny or less active.
3. Written informed consent according to the applicable law;
4. Willingness and ability to comply with all procedures of the trial.

E.4

Principal exclusion criteria

Subjects presenting any of the following criteria will not be included in the study:
1. Severe or complicated course of the URTI (e.g. shortness of breath, dyspnoea, tachypnea, hypoxia, central nervous system (CNS) findings, severe dehydration, renal failure, multi-organ failure, septic shock, musculoskeletal (rhabdomyolysis) and cardiac (myocarditis) complications);
2. Signs of acute lower respiratory tract disease (e.g. bronchiolitis, bronchitis, pneumonia);
3. Current symptoms mainly induced by other acute ENT (Ear-Nose-Throat) disease such as tonsillitis, sinusitis, otitis media;
4. Any present chronic inflammatory ENT and respiratory tract disease (e.g. allergic rhinitis, bronchitis, bronchial asthma, obstructive pulmonary disease (COPD), cystic fibrosis and adenoidal hypertrophy);
5. Obstructive anatomic lesions in the nasopharynx such as nasal polyps, tumours or severe septal deviations;
6. Patients with severe heart diseases, HIV-infection, unstable diabetes mellitus, coeliac disease and/or immunosuppression and only for adolescents-adults tuberculosis as well as lues at any stage;
7. Patients with severe renal or hepatic dysfunction at any time during the past 12 months prior to enrolment into the trial;
8. Children with congenital anomalies of heart, kidney or liver;
9. Any significant alarm symptom within the past 6 months prior to enrolment into the trial, e.g. unintentional weight loss, or any other sign indicating serious or malignant disease;
10. Evidence of any malignant disease during the past 5 years prior to enrolment into the trial;
11. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption;
12. Hypersensitivity to any of the ingredients and/or excipients of Influcid;
13. Hypersensitivity to any of the ingredients and/or excipients as well as any known contraindications to the symptomatic treatment defined in this protocol;
14. Positive rapid test for group A β-hemolytic streptococci (GABHS);
15. Treatment with antibiotics, glucocorticosteroids, immunomodulators (including drugs contraining probiotics), or antihistamines during the past 4 weeks prior to or at enrolment into the trial as well as current indication requiring these drugs during the trial;
16. Indication for administration of or treatment with antiviral drugs (e.g. oseltamivir);
17. Treatment with any antipyretics, nasal decongestants, expectorants and/or any other cold medication or measure for relief of URTI e.g. local anesthetics, anti-inflammatory drugs, antitussiva, homeopathic drugs, nutritional supplements or drugs containing zinc, echinacea, garlic or vitamin C (³ 100 mg per day), during the past 7 days prior to or at enrolment into the trial;
18. Heavy smoking or known or suspected drug addiction incl. alcohol abuse;
19. Women of childbearing potential without adequate contraception or women, who want to become pregnant, are pregnant or breast-feeding;
20. Participation in another clinical trial during the past 3 months prior to enrolment into the trial;
21. For patients ≥ 18 years: Incompetence or incapability of understanding nature, meaning and consequences of the trial;
For patients < 18 years: Irresponsible parents or their legal representatives unable to understand nature, meaning and consequences of the trial.

E.5 End points

E.5.1

Primary end point(s)

Number of responders (patients without fever (axillary temperature ≤ 37.2°C) and without symptoms or with very mild degree of the symptoms only as assessed by item 1 of WURSS-21) at day 4.

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

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)

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

add-on trial: all receive PR2, PR3 and/or PR4/PR5; one group will receive additionally Influcid

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.8.3

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

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)

Yes

F.1.1.5

Children (2-11years)

Yes

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-08-13.

Yes

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

520

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)

Uncomplicated URTI are usually self-limited illnesses and the symptoms generally resolve after a week. In cases the symptoms persist at the end of the study (day 15) or the patients premature discontinue the participation in the study, they will receive a standard therapy, adapted to their disease, at the discretion of the investigator.

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

2010-09-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-10-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-07-04

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