Clinical Trials Register

Summary
EudraCT Number:	2010-022819-19
Sponsor's Protocol Code Number:	P1001GF
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:	2010-10-29
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

2010-022819-19

A.3

Full title of the trial

Efficacy, safety and tolerability of two weeks treatment with SIA capsules in acute bronchitis - A multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial -

A.3.1

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

Efficacy, safety and tolerability of two weeks treatment with SIA capsules in acute bronchitis - A multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial -

A.3.2

Name or abbreviated title of the trial where available

SIA in acute bronchitis

A.4.1

Sponsor's protocol code number

P1001GF

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	G. Pohl-Boskamp 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	G.Pohl-Boskamp GmbH & Co. KG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pharmalog Institut für klinische Forschung GmbH
B.5.2	Functional name of contact point	Astrid Clausen Project Manager
B.5.3	Address:
B.5.3.1	Street Address	Neumarkter Str 18
B.5.3.2	Town/ city	Munich
B.5.3.3	Post code	81673
B.5.3.4	Country	Germany
B.5.4	Telephone number	00498954463733
B.5.5	Fax number	00498954463750
B.5.6	E-mail	clausen@pharmalog.com

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	GeloMyrtol forte
D.2.1.1.2	Name of the Marketing Authorisation holder	G. Pohl-Boskamp
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.3.1	Product name	SIA capsules
D.3.2	Product code	N/A
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
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	6096046.00.00
D.3.9.1	CAS number	0
D.3.9.2	Current sponsor code	P1001GF
D.3.9.3	Other descriptive name	Destillate of mixture of rectified oil of eucalyptus, sweet orange, myrtle, lemon
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	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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)	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	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.3.11.13.1	Other medicinal product type	N/A

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

acute bronchitis

E.1.1.1

Medical condition in easily understood language

It is a transient and self-limited condition caused by an inflammation of the mucous membrane that lines the air passages of the lower airways.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13.1
E.1.2	Level	LLT
E.1.2	Classification code	10000687
E.1.2	Term	Acute bronchitis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the effect of SIA capsules versus placebo during a two-week treatment period (300 mg four times a day [q.i.d.]) in adult patients with acute bronchitis.

E.2.2

Secondary objectives of the trial

To assess the safety and tolerability of two weeks treatment with SIA capsules compared to placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. A signed and dated written informed consent and data protection declaration
2. Male and female outpatients
3. Race: Caucasian
4. Age: ³ 18 years
5. Weight: Broca Index 0.75 – 1.30
6. Clinical diagnosis of acute bronchitis as characterized by:
- ≥ 10 coughing fits during the last day prior to Visit 1 (according to patient´s estimate)
- Baseline Bronchitis Severity Score (BSS) ≥ 5 points (of maximum 20 points)
- Onset of first symptoms (bronchial mucus production with impaired ability to cough up) within two days before treatment initiation.

E.4

Principal exclusion criteria

1. Prohibited previous and concomitant medication (see below)
2. Medical history or presence of the following respiratory diseases:
- Recent upper respiratory tract infection (< 4 weeks)
- Chronic bronchitis or acute exacerbations of chronic bronchitis
- Chronic obstructive pulmonary disease (COPD) or acute exacerbation of COPD
- Bronchiectasis
- Bronchial asthma
- Suspected Pneumonia
- Mucoviscidosis
- Lung cancer (except other malignancies, if they are in remission ³ 5 years)
3. Concomitant bacterial infection
4. Body temperature > 39.5°C rectal or >39.0°C axillary or otic
5. Tobacco smoking > 1 pack of cigarettes per day
6. Known hypersensitivity to one or more of the active and / or inactive ingredients of the product (e.g. eucalyptus oil, sweet orange oil, myrtle oil, lemon oil or cineole, cineole [the main constituent of eucalyptus oil])
7. Inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct
8. History or presence of clinically relevant cardiovascular, renal, metabolic, haematological, dermatologic, neurological, psychiatric, systemic or infectious disease
9. Any other comorbidity is only allowed if it does not interfere with the eligibility criteria and the evaluation of the study endpoints
10. Pregnant or breastfeeding women
11. Women of childbearing potential without highly effective contraception (failure rate less than 1%)
12. Current participation in a research study involving an investigational product or within the last 6 weeks
13. Previous participation in this clinical study
14. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
15. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
16. Patients in custody by juridical or official order
17. Evidence of an uncooperative attitude (non-compliance)
18. Patients who have difficulties in understanding the language in which the patient information is given
19. Patients who do not agree to the transmission of their pseudonymous data within the liability of documentation and notification
Not permitted within 4 weeks before Visit 1
· Antibiotics
· Systemic or inhalation glucocorticosteroids
· Start of angiotensin converting enzymes (ACE) inhibitors
Not permitted within 2 calendar days before Visit 1:
· Secretolytics, mucolytics, and antitussive drugs (e.g. codeine or other morphine derivatives)
Not permitted from Visit 1 to Visit 4:
· Any inhalation and / or physical therapy of acute bronchitis
· Expectorants / mucoactive drugs
· Antitussive drugs (e.g. codeine or other morphine derivatives)
· Analgesics (except paracetamol)
· Sedatives / hypnotics or sedating antihistamines
· Systemic antibiotics
· Systemic or inhalation corticosteroids
· Medications causing cough:
- ACE inhibitors
- Angiotensin II receptor antagonists (e.g. valsartan, losartan)
- Antiarrhythmic (e.g. amiodaron)
- Inhaled bronchodilators, such as beta 2-agonists (e.g. salmeterol) and inhaled anticholinergics (e.g. ipratropium bromide)
- Inhaled corticosteroids (e.g. budesonide)
- Inhaled chromoglycate

E.5 End points

E.5.1

Primary end point(s)

13.1 Primary efficacy endpoint: Mean in coughing fits(Day 7, Day 8, Day 9) / coughing fits(Day 1)
The coughing fits counted by the patients on Day 7, Day 8 and Day 9 (starting with getting up in the morning and ending with bedtime) will be divided by the number of observed days (3 days). Due to the need to adjust for the influence of the baseline value (higher baseline values lead with a high probability to higher values on Day 7, Day 8 and Day 9), this mean value will be divided through the baseline value (Day 1) for each patient (standardized to the first day of patient’s precise recording with a manual counter).

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

Yes

E.6.13.1

Other scope of the trial description

tolerability

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)

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

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

please see study protocol

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	400
F.4.2	For a multinational trial
F.4.2.1	In the EEA	400
F.4.2.2	In the whole clinical trial	400

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

2010-12-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-11-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-05-29

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