Seasonal Allergic RhinitisPhase 2PETRANCT00862225
MOA Study of Ze 339 in Seasonal Allergic Rhinitis
A Phase 2 study testing Desloratadin and IG-RD-001 / Ze 339 in people with Seasonal Allergic Rhinitis, run by Max Zeller Soehne AG at 1 site in Germany.
Trial summary
Randomised, double-blind and prospective clinical study to examine the mechanism of action of the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of severity (provoked by grasses). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Desloratadin and IG-RD-001 / Ze 339
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allergic rhinitis since at least 2 years
- Age: = > 18 years
- Consent in accordance with the AMG (=German Drug Law)
- Positive skin test, skin prick test or positive RAST for grasses The skin prick test is positive if the wheal is >= 3 mm greater than control; a skin test is positive if the wheal is >= 7 mm greater than control
- Women of childbearing potential have to use a highly effective method of birth control (according CPMP/ICH/286/95 Note 3) during the duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Who cannot join
- Past or current psychological disease or disorder which can impair the study participant's ability to understand the study requirements, t take part in the study or give consent after briefing
- Past or current alcohol or medication dependency or abuse
- Bronchial asthma (FEV < 80 %)
- Glaucoma, cataract or ocular herpes simplex
- Clinically relevant deviations from normal laboratory parameters (if known)
- Antihistamines with a long-term effect
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- Malignant diseases, including in the patient's case history
- Parasites
- Study participants who are taking part in another study or took an investigational product during the last 4 weeks before the start of treatment
- Progressive systemic diseases such as tuberculosis, leukoses, collagenoses, multiple sclerosis, Aids, HIV infection and other autoimmune diseases
- Other types of rhinitis with different causes, acute or chronic sinusitis
- Pregnancy or lactation
- Serious internal diseases, e.g. serious decompensated diseases of the heart, liver, kidneys or diabetes mellitus
- Patients with rarely occurring hereditary problems galactose-intolerance, Lapp-lactase-deficiency or glucose-galactose-malabsorption
- Pre-existing liver damage
- The use of non-steroidal antirheumatic agents (NSAR)
- Hypersensitivity towards one of the ingredients in the investigational product
- Not adhering to the following periods of abstention before the nasal provocation test: 3 days for DNCG, nedocromil, nasal and oral antihistamines, and tricyclic psychotropic drugs, 1 months systemic treatment with glucocorticoids, 14 days for nasal and topical corticosteroids, 1 week for antihistamines, and 1 day for α-adrenergic drugs. The use of ACE inhibitors or ß-blockers
- Previous organ transplants
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Otorhinolaryngology and Head and Neck Surgery
Düsseldorf
About this study
Official title: Randomized, Double-blind Prospective Clinical Study to Examine the Mechanism of Action of IG-RD-001 (Ze-339) Compared to Desloratadine and Placebo in Patients With Seasonal Allergic Rhinitis Who Are Sensitized to Grasses
Randomised, double-blind and prospective clinical study to examine the mechanism of action of the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of severity (provoked by grasses). The treatment arm with desloratadine is an established standard treatment and is intended to ensure the comparative methodology of the study.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo, Desloratadin, IG-RD-001 / Ze 339
- Keywords
- rhinomanometry, mode of action, grass pollen
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
DesloratadinDrug
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
IG-RD-001 / Ze 339Drug
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: Desloratadin |
| 3 | Experimental | Not described Receives: Drug: IG-RD-001 / Ze 339 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Measured: 0-24 hours post nasal provocation test
Secondary outcomes (1)
Clinical symptom score (rhinorrhoea, nasal congestion, nasal itching and sneezing), assessment by the investigator (nasal secretion, irritation, occurrence of systemic symptoms), mediators in the serum, nasal secretion, nasal curettage and biopsy
Measured: 0-24h post nasal provocation test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Zeller Soehne AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862225
- Sponsor's protocol ID
- PETRA_IG-RD-001 (Ze339)
- Other IDs
- EudraCT-Number: 2007-006090-89
- Acronym
- PETRA
- Status last verified
- Jan 2012
- First submitted
- 13 Mar 2009
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Prospective Clinical Study to Examine the Mechanism of Action of IG-RD-001 (Ze-339) Compared to Desloratadine and Placebo in Patients With Seasonal Allergic Rhinitis Who Are Sensitized to Grasses
- ClinicalTrials.gov ID
- NCT00862225
- Acronym / sponsor ID
- PETRA / PETRA_IG-RD-001 (Ze339)
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- rhinomanometry, mode of action, grass pollen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Max Zeller Soehne AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Mar 2009 (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.
Randomised, double-blind and prospective clinical study to examine the mechanism of action of the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of severity (provoked by grasses). The treatment arm with desloratadine is an established standard treatment and is intended to ensure the comparative methodology of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: Desloratadin |
| 3 | Experimental | Drug: IG-RD-001 / Ze 339 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Allergic rhinitis since at least 2 years
- Age: = > 18 years
- Consent in accordance with the AMG (=German Drug Law)
- Positive skin test, skin prick test or positive RAST for grasses The skin prick test is positive if the wheal is >= 3 mm greater than control; a skin test is positive if the wheal is >= 7 mm greater than control
- Women of childbearing potential have to use a highly effective method of birth control (according CPMP/ICH/286/95 Note 3) during the duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Key exclusion criteria (19 listed)
- Past or current psychological disease or disorder which can impair the study participant's ability to understand the study requirements, t take part in the study or give consent after briefing
- Past or current alcohol or medication dependency or abuse
- Bronchial asthma (FEV < 80 %)
- Glaucoma, cataract or ocular herpes simplex
- Clinically relevant deviations from normal laboratory parameters (if known)
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 |
|---|---|---|
| PlaceboFollowing a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter. | Drug | 1 |
| DesloratadinFollowing a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter. | Drug | 2 |
| IG-RD-001 / Ze 339Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter. | Drug | 3 |
Primary outcome
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Time frame: 0-24 hours post nasal provocation test
1 secondary outcome
Clinical symptom score (rhinorrhoea, nasal congestion, nasal itching and sneezing), assessment by the investigator (nasal secretion, irritation, occurrence of systemic symptoms), mediators in the serum, nasal secretion, nasal curettage and biopsy
Time frame: 0-24h post nasal provocation test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Link to publication in PubMedLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Desloratadin and IG-RD-001 / Ze 339 in people with Seasonal Allergic Rhinitis, run by Max Zeller Soehne AG 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 19 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: finished, as of the sponsor's last update on 26 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter. (time frame: 0-24 hours post nasal provocation test). 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 26 Jan 2012.