Rhinitis, Allergic, SeasonalNAPONCT03772405
Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms
A study testing Nascum Plus and ACC in people with Rhinitis, Allergic, Seasonal, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®- Plus, is able to prevent or minimize the induction of nasal symptoms during allergen challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Nascum Plus and ACC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2018to 1 Feb 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Able and willing to give written informed consent.
- 2. Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- 3. Body mass index between 18 and 32 kg/m²
- 4. History of seasonal allergic rhinitis to grass pollen
- 5. Positive skin prick test for Dactylis glomerata pollen at screening or within 12 months prior to the screening visit.
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- 6. Normal lung function Forced Expiratory Volume in one second (FEV1) ≥ 80 % pred and FEV1/Forced Vital Capacity (FVC) >70% at screening
- 7. Adequate level of rhinitis symptoms in a grass pollen challenge, defined as a Total Nasal Symptom Score (TNSS) of at least 6 (of 12) within the 2-hour grass pollen challenge at performed at the Screening ACC visit (V2).
- 8. TNSS of 3 prior to entering the pollen chamber at screening.
- 9. Non-smokers or ex-smokers since at least 6 months with a history of less than 10 pack years
Who cannot join
- 1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urine analysis, vital signs, lung function or Electrocardiogram (ECG) at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study
- 2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- 3. History of an acute infection four weeks prior to the informed consent visit
- 4. Specific Immunotherapy (SIT) within 2 years prior to the study
- 5. Rhinitis of other cause, chronic sinusitis or rhinitis or sinusitis in the last 14 days before entering the study
- 6. Asthma requiring more than inhaled short-acting beta-2 agonists.
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- 7. Conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ACC for 4 hours.
- 8. Any contraindication for adrenalin use (e.g. use of local and systemic beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors
- 9. Treatment with antipsychotic medications with antihistaminic effect (e.g. chlorpromazine, levomepromazine, clozapine, olanzapine, tioridazine)
- 10. Use of any medications according to section 8.2 in the period indicated before allergen challenge
- 11. Participation in another clinical trial 30 days prior to enrollment.
- 12. History of drug or alcohol abuse
- 13. Risk of non-compliance with study procedures
- 14. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Over Study to Assess the Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms and Inflammatory Cells and Cytokines During and After Allergen Challenge in the Fraunhofer Allergen Challenge Chamber (ACC)
The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®- Plus, is able to prevent or minimize the induction of nasal symptoms during allergen challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on soluble and cellular inflammatory markers induced by the allergic reaction will be assessed. Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical excipients.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Nascum Plus, ACC
- 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.
Nascum PlusDrug
nasal application of nascum plus
ACCOther
4 hours challenge to grass pollen in the allergen challenge chamber (ACC)
| Study group | Role | What they receive |
|---|---|---|
| Nascum Plus and ACC | Experimental | In a cross-over design, patients are exposed to pollen in the ACC twice for 4 hours each 3 weeks apart. Subjects will receive treatment with Nascum Plus either 5 minutes before the first or the second 4 hour pollen challenge. Receives: Drug: Nascum Plus; Other: ACC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
Change of TNSS assessed during grass pollen challenge in ACC
Measured: pre start of challenge and every 20 minutes during 4 hours challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start12 Dec 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- M et P Pharma AG
- Responsible party
- Principal investigator, Philipp Badorrek, Fraunhofer-Institute of Toxicology and Experimental Medicine
- Investigators
- Philipp Badorrek, MD, Principal investigator, The Fraunhofer-Gesellschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772405
- Sponsor's protocol ID
- 18-05 NAPO
- Acronym
- NAPO
- Status last verified
- Feb 2019
- First submitted
- 10 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Over Study to Assess the Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms and Inflammatory Cells and Cytokines During and After Allergen Challenge in the Fraunhofer Allergen Challenge Chamber (ACC)
- ClinicalTrials.gov ID
- NCT03772405
- Acronym / sponsor ID
- NAPO / 18-05 NAPO
- Conditions
- Rhinitis, Allergic, Seasonal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- M et P Pharma AG
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 11 Dec 2018 (actual)
- 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 aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®- Plus, is able to prevent or minimize the induction of nasal symptoms during allergen challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on soluble and cellular inflammatory markers induced by the allergic reaction will be assessed. Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical excipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nascum Plus and ACC | Experimental | Drug: Nascum Plus, Other: ACCIn a cross-over design, patients are exposed to pollen in the ACC twice for 4 hours each 3 weeks apart. Subjects will receive treatment with Nascum Plus either 5 minutes before the first or the second 4 hour pollen challenge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Able and willing to give written informed consent.
- 2. Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- 3. Body mass index between 18 and 32 kg/m²
- 4. History of seasonal allergic rhinitis to grass pollen
Key exclusion criteria (14 listed)
- 1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urine analysis, vital signs, lung function or Electrocardiogram (ECG) at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study
- 2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- 3. History of an acute infection four weeks prior to the informed consent visit
- 4. Specific Immunotherapy (SIT) within 2 years prior to the study
- 5. Rhinitis of other cause, chronic sinusitis or rhinitis or sinusitis in the last 14 days before entering the study
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 |
|---|---|---|
| Nascum Plusnasal application of nascum plus | Drug | Nascum Plus and ACC |
| ACC4 hours challenge to grass pollen in the allergen challenge chamber (ACC) | Other | Nascum Plus and ACC |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: pre start of challenge and every 20 minutes during 4 hours challenge
Change of TNSS assessed during grass pollen challenge in ACC
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 15 Feb 2019.
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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.
Philipp Badorrek, MD principal investigator
The Fraunhofer-Gesellschaft
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nascum Plus and ACC in people with Rhinitis, Allergic, Seasonal, run by Fraunhofer-Institute of Toxicology and Experimental Medicine 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 10 inclusion and 14 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 15 Feb 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Total Nasal Symptom Score (TNSS) (time frame: pre start of challenge and every 20 minutes during 4 hours challenge). 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 Feb 2019.