AsthmaPhase 2HeHeNCT01692041
Effect of an add-on Treatment With Ivy Leaves Dry Extract on Lung Function in Bronchial Asthma
A Phase 2 study testing ivy leaves dry extract in people with Asthma, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The trial aims to record possible effects of a supplementary treatment with ivy leaves dry extract on different lung function parameter, on bronchial hyperreactivity, on individual markers of asthmatic inflammation and on the clinical symptom profile. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- ivy leaves dry extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Dec 2013
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011)
- Children aged from 6 to 12 years (girls and boys)
- Signed Informed Consent of the patient and his legal guardians to participate in the trial after written and verbal briefing by the Investigator
- Improvement of the FEV1≥12% after 2 puffs of terbutaline 100 µg dur-ing steroid monotherapy with 400 µg budesonide equivalent/day or an ACT score ≤ 19 as an indication of insufficient asthma control
- Asthma diagnosis for at least 1 year
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 measure lung function, to test bronchospasmolysis, to determine FeNO or to collect exhaled breath condensate, inability to document the symptoms in a symptom log book or questionnaire; in-ability to take the trial medication properly
- Chronic illnesses of different aetiology
- Vocal cord dysfunction
Show all 11Show fewer
- Premature birth or diagnosis of bronchopulmonary dysplasia
- Gastroesophageal reflux
- Acute respiratory infection within the previous 4 weeks
- Hereditary fructose intolerance
- Pregnant or breastfeeding girls -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus, Kinderklinik
Dresden, Saxony, 01307
Christian Vogelberg, MD PhD, 0049 351 458 ext. 2073, christian.vogelberg@uniklinikum-dresden.de
Christian Vogelberg, MD PhD
About this study
Official title: Tolerance and Effect of an add-on Treatment With a Cough Medicine Containing Ivy Leaves Dry Extract on Lung Function in Children With Bronchial Asthma
The trial aims to record possible effects of a supplementary treatment with ivy leaves dry extract on different lung function parameter, on bronchial hyperreactivity, on individual markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is, that the additional therapy might improve these parameters and might help to optimize asthma therapy.
- Conditions
- Asthma
- Being tested
- ivy leaves dry extract, Placebo
- Keywords
- asthma, children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivy leaves dry extractDrug
5 ml twice daily po
PlaceboDrug
5 ml per os twice daily
| Study group | Role | What they receive |
|---|---|---|
| Ivy leave | Active comparator | active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks Receives: Drug: ivy leaves dry extract |
| Placebo | Placebo comparator | Ivy leave placebo 5 ml twice daily p.o. for four weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEF75-25 before bronchodilation - relative change
MEF75-25 will be measured at every time point of the study and relative changes will be followed
Measured: every 4 weeks
FEV1 before bronchodilation - relative change
FEV1 before bronchodilation will be measured at every study visit and changes will be documented
Measured: every 4 weeks
Secondary outcomes (4)
MEF75-25 before bronchodilation - absolute change
Measured: every 4 weeks
FEV1 before bronchodilation - absolute change
FEV1 before bronchodilation will be measured every visit and changes documented
Measured: every 4 weeks
Emergency treatment (beta agonist demand)
Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit
Measured: daily
Number of days with asthma symptoms
Number of days with asthma symptoms will be documented daily and checked at every study visit.
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692041
- Sponsor's protocol ID
- HeHe
- Acronym
- HeHe
- Status last verified
- Sep 2012
- First submitted
- 3 May 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Effect of an add-on Treatment With a Cough Medicine Containing Ivy Leaves Dry Extract on Lung Function in Children With Bronchial Asthma
- ClinicalTrials.gov ID
- NCT01692041
- Acronym / sponsor ID
- HeHe / HeHe
- Conditions
- Asthma
- Keywords
- asthma, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Sep 2012 (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 trial aims to record possible effects of a supplementary treatment with ivy leaves dry extract on different lung function parameter, on bronchial hyperreactivity, on individual markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is, that the additional therapy might improve these parameters and might help to optimize asthma therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivy leave | Active comparator | Drug: ivy leaves dry extractactive therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks |
| Placebo | Placebo comparator | Drug: PlaceboIvy leave placebo 5 ml twice daily p.o. for four weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011)
- Children aged from 6 to 12 years (girls and boys)
- Signed Informed Consent of the patient and his legal guardians to participate in the trial after written and verbal briefing by the Investigator
- Improvement of the FEV1≥12% after 2 puffs of terbutaline 100 µg dur-ing steroid monotherapy with 400 µg budesonide equivalent/day or an ACT score ≤ 19 as an indication of insufficient asthma control
- Asthma diagnosis for at least 1 year
Key exclusion criteria (11 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 measure lung function, to test bronchospasmolysis, to determine FeNO or to collect exhaled breath condensate, inability to document the symptoms in a symptom log book or questionnaire; in-ability to take the trial medication properly
- Chronic illnesses of different aetiology
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 |
|---|---|---|
| ivy leaves dry extract5 ml twice daily po | Drug | Ivy leave |
| Placebo5 ml per os twice daily | Drug | Placebo |
Primary outcome
MEF75-25 before bronchodilation - relative change
Time frame: every 4 weeks
MEF75-25 will be measured at every time point of the study and relative changes will be followed
FEV1 before bronchodilation - relative change
Time frame: every 4 weeks
FEV1 before bronchodilation will be measured at every study visit and changes will be documented
4 secondary outcomes
MEF75-25 before bronchodilation - absolute change
Time frame: every 4 weeks
FEV1 before bronchodilation - absolute change
Time frame: every 4 weeks
Emergency treatment (beta agonist demand)
Time frame: daily
Number of days with asthma symptoms
Time frame: daily
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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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.
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 ivy leaves dry extract in people with Asthma, 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 11 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 25 Sep 2012. 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 (0049 351 458 2073, 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?
MEF75-25 before bronchodilation - relative change (time frame: every 4 weeks). The study lists 2 primary outcomes in all. 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 25 Sep 2012.