Symptoms of Acute Bronchitis Accompanied by CoughingPhase 3NCT01127048
Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children
A Phase 3 study testing Suppositories containing Ivy leaves dry extract in people with Symptoms of Acute Bronchitis Accompanied by Coughing, run by Engelhard Arzneimittel GmbH & Co.KG at 1 site in Germany.
Trial summary
The aims of this study are Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Symptoms of Acute Bronchitis Accompanied by Coughing
- What is being tested?
- Suppositories containing Ivy leaves dry extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,400 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male or female children aged 0 to 6 years
- acute bronchitis existing not longer than three days and accompanied by coughing
- symptom rating score of ≥ 5 assessed by the investigator
- symptom 'frequency of coughing' of ≥ 2 assessed by the investigator
- the patient's legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study -
Who cannot join
- hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations
- patients with severe allergies or multiple drug allergies
- any other pulmonary disease within the last two weeks
- chronic pulmonary diseases
- exacerbation of chronic pulmonary disease
- suspicion of bacterial pulmonary infection
- fever above 39°C (rectal measurement) -
Trial locations and contacts
1 site in 1 country.
Manuela Stauss-Grabo, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Engelhard Arzneimittel GmbH & Co. KG
Niederdorfelden, 61138
Manuela Stauss-Grabo, Dr.
About this study
Official title: Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children
The aims of this study are
- Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing
- Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.
Read the detailed description
After interim analysis of the first part the clinical study will be continued as follows: Double blind, placebo controlled, randomised, multi-centre study with 2-parallel groups for the treatment of acute bronchitis accompanied by coughing in children aged 0 - 6 years to demonstrate efficacy and safety of Prospan® Hustenzäpfchen.
For assessment of cough intensity and severity a specific symptom score has been developed, which gathers the child's frequency and severity of coughing and of cough productivity as well as the severity of rhonchi (each symptom will be assessed on a four-point Likert scale ranging from 0 to 3; total score range: 0-12 points).
Considering the specificities of the study population and the disease, confirmatory evaluation will be based on the change in the symptom score after the first three consecutive days of treatment as assessed by the investigator.
- Being tested
- Suppositories containing Ivy leaves dry extract, Placebo
- Keywords
- bronchitis, coughing, children, Ivy, Hedera helix L.
- Medical subject headings
- Bronchitis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suppositories containing Ivy leaves dry extractDrug
Also called Prospan® Hustenzäpfchen
Suppositories containing Ivy leaves dry extract
PlaceboDrug
Suppositories containing no Ivy leaves dry extract
| Study group | Role | What they receive |
|---|---|---|
| Prospan Hustenzäpfchen | Experimental | Not described Receives: Drug: Suppositories containing Ivy leaves dry extract |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
Effect of treatment as primary variable will be assessed by comparing baseline values to those obtained during visit 2.
The primary outcome measure for efficacy will be the relative change in the symptom score between visits 1 and 2.
Measured: 7 days
Secondary outcomes (1)
Secondary variables
- absolute change of total symptom score
- time to response
- compliance, defined by drug accountability
- percentage of patients requiring concomitant medication for treatment of cough
- rates of premature withdrawal
- incidence of Adverse Events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startOct 2008
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms of Acute Bronchitis Accompanied by CoughingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerhard Zwacka, Prof. Dr., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127048
- Sponsor's protocol ID
- EA-08-1-34
- Status last verified
- May 2010
- First submitted
- 3 May 2010
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children
- ClinicalTrials.gov ID
- NCT01127048
- Acronym / sponsor ID
- EA-08-1-34
- Keywords
- bronchitis, coughing, children, Ivy, Hedera helix L.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KGIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are
- Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing
- Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.
Detailed description
After interim analysis of the first part the clinical study will be continued as follows: Double blind, placebo controlled, randomised, multi-centre study with 2-parallel groups for the treatment of acute bronchitis accompanied by coughing in children aged 0 - 6 years to demonstrate efficacy and safety of Prospan® Hustenzäpfchen.
For assessment of cough intensity and severity a specific symptom score has been developed, which gathers the child's frequency and severity of coughing and of cough productivity as well as the severity of rhonchi (each symptom will be assessed on a four-point Likert scale ranging from 0 to 3; total score range: 0-12 points).
Considering the specificities of the study population and the disease, confirmatory evaluation will be based on the change in the symptom score after the first three consecutive days of treatment as assessed by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospan Hustenzäpfchen | Experimental | Drug: Suppositories containing Ivy leaves dry extract |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- male or female children aged 0 to 6 years
- acute bronchitis existing not longer than three days and accompanied by coughing
- symptom rating score of ≥ 5 assessed by the investigator
- symptom 'frequency of coughing' of ≥ 2 assessed by the investigator
- the patient's legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study -
Key exclusion criteria (7 listed)
- hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations
- patients with severe allergies or multiple drug allergies
- any other pulmonary disease within the last two weeks
- chronic pulmonary diseases
- exacerbation of chronic pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suppositories containing Ivy leaves dry extractAlso: Prospan® HustenzäpfchenSuppositories containing Ivy leaves dry extract | Drug | Prospan Hustenzäpfchen |
| PlaceboSuppositories containing no Ivy leaves dry extract | Drug | Placebo |
Primary outcome
Primary outcome measure
Time frame: 7 days
Effect of treatment as primary variable will be assessed by comparing baseline values to those obtained during visit 2. The primary outcome measure for efficacy will be the relative change in the symptom score between visits 1 and 2.
1 secondary outcome
Secondary variables
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Stauss-Grabo, Dr. contact
Gerhard Zwacka, Prof. Dr. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suppositories containing Ivy leaves dry extract in people with Symptoms of Acute Bronchitis Accompanied by Coughing, run by Engelhard Arzneimittel GmbH & Co.KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuela Stauss-Grabo, Dr. (m.stauss-grabo@engelhard-am.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2011.