Open label clinical trial to determine the blood ethanol concentration following repeated administration of Bronchicum Elixir to children (1 to 12 years) with acute bronchitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014904-73-DE

Enrollment

Registered

2009-12-03

Start date

2010-01-13

Completion date

Unknown

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute bronchitis

Interventions

Trade Name: Bronchicum Elixir Pharmaceutical Form: Oral liquid CAS Number: 800024842 Other descriptive name: THYME LIQUID EXTRACT Concentration unit: % (W/W) percent weight/weight Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: - children between the age of 1 and 12 years - diagnosis of acute bronchitis (according to bronchitis severity score, BSS = 5) - written informed consent of the patient's parents to participate Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Obstructive or non-obstructive chronic bronchitis - Allergic bronchial asthma - Parallel treatment with antibiotics, glucocorticoids, beta-mimetics - theophylline, expectorants or antitussives or any treatment with this type of medication during 7 days before trial start (antibiotics: 4 weeks before trial start) - indication for treatment with antibiotics (fever of = 39°C) - known sensitivity to the ingredients of the investigational product - pathological laboratory findings, any severe organ- or systemic disease - the exclusion of minors, who have been committed to a youth institution by official directive or judicial order. - simultaneous participation in another clinical trial or participation in a clinical trial during 4 weeks before start of this clinical trial - inability to comply with study protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this open label clinical trial is to determine if blood ethanol concentration reaches a critical value (0,125‰) after repeated administration of a dose of the IMP to children in the age between 1 and 12 years.;Secondary Objective: The secondary objectives of this clinical trial are: -To asses the efficacy of the IMP in reducing the severity of bronchitis symptoms using the Bronchitis Severity Score -To evaluate the global efficacy and safety of the IMP by the investigator -To evaluate the global efficacy and safety of the IMP by the patients /their parents ;Primary end point(s): Primary endpoint: - proof that after administration of investigational product (0, 45 and 90 minutes post administration), blood ethanol concentration stays below the critical value of 0,125‰	—

Measure

Time frame

Main Objective: The main objective of this open label clinical trial is to determine if blood ethanol concentration reaches a critical value (0,125‰) after repeated administration of a dose of the IMP to children in the age between 1 and 12 years.;Secondary Objective: The secondary objectives of this clinical trial are: -To asses the efficacy of the IMP in reducing the severity of bronchitis symptoms using the Bronchitis Severity Score -To evaluate the global efficacy and safety of the IMP by the investigator -To evaluate the global efficacy and safety of the IMP by the patients /their parents ;Primary end point(s): Primary endpoint: - proof that after administration of investigational product (0, 45 and 90 minutes post administration), blood ethanol concentration stays below the critical value of 0,125‰

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026