Acute Wheezy BronchitisPhase 2NCT02045550
Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis
A Phase 2 study testing Prospan Syrup in people with Acute Wheezy Bronchitis and Recurrent Bronchitis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Acute Wheezy Bronchitis, Recurrent Bronchitis
- What is being tested?
- Prospan Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Aug 2015
- Phase
- Phase 2
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
- Children aged from 1 to 3 years (girls and boys)
- Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
- No allergic sensitization
- Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes
Who cannot join
- Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
- Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
- Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
- Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
- Any regular therapy except Vitamin D or Fluoride
- Chronic illnesses of different aetiology
Show all 9Show fewer
- Premature birth or diagnosis of bronchopulmonary dysplasia
- Gastro-oesophageal reflux
- Hereditary fructose intolerance
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin
Dresden, Saxony, 01307
Christian Vogelberg, MD PhD, 0049351458 ext. 2073, christian.vogelberg@uniklinikum-dresden.de
Sabine Zeil, MD
About this study
Official title: Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis
To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.
- Conditions
- Acute Wheezy Bronchitis, Recurrent Bronchitis
- Being tested
- Prospan Syrup
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospan SyrupDrug
2.5 ml twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Syrup | Placebo comparator | Placebo Syrup 2.5 ml twice daily for 4 weeks |
| Prospan Syrup | Active comparator | Prospan Syrup 2.5 ml twice daily for 4 weeks Receives: Drug: Prospan Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to event (next bronchitis episode) rate during and after treatment period
Measured: three months
Secondary outcomes (2)
days and percentage of days without bronchitis during and after treatment period
Measured: 3 months
days and percentage of days without bronchitis during treatment period
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Wheezy BronchitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Vogelberg, MD PhD, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045550
- Sponsor's protocol ID
- HeHe02
- Status last verified
- Jan 2014
- First submitted
- 13 Jan 2014
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis
- ClinicalTrials.gov ID
- NCT02045550
- Acronym / sponsor ID
- HeHe02
- Conditions
- Acute Wheezy Bronchitis, Recurrent Bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 27 Jan 2014 (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.
To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Syrup | Placebo comparator | –Placebo Syrup 2.5 ml twice daily for 4 weeks |
| Prospan Syrup | Active comparator | Drug: Prospan SyrupProspan Syrup 2.5 ml twice daily for 4 weeks |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
- Children aged from 1 to 3 years (girls and boys)
- Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
- No allergic sensitization
- Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes
Key exclusion criteria (9 listed)
- Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
- Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
- Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
- Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
- Any regular therapy except Vitamin D or Fluoride
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 |
|---|---|---|
| Prospan Syrup2.5 ml twice daily for 4 weeks | Drug | Prospan Syrup |
Primary outcome
the time to event (next bronchitis episode) rate during and after treatment period
Time frame: three months
2 secondary outcomes
days and percentage of days without bronchitis during and after treatment period
Time frame: 3 months
days and percentage of days without bronchitis during treatment period
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
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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.
Christian Vogelberg, MD PhD principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prospan Syrup in people with Acute Wheezy Bronchitis and Recurrent Bronchitis, run by Technische Universität Dresden 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 9 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 27 Jan 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Christian Vogelberg, MD PhD (0049351458 ext. 5699, christian.vogelberg@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to event (next bronchitis episode) rate during and after treatment period (time frame: three months). 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 27 Jan 2014.