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Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms (NAPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772405
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
M et P Pharma AG
Information provided by (Responsible Party):
Philipp Badorrek, Fraunhofer-Institute of Toxicology and Experimental Medicine

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: Nascum Plus Other: ACC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 12, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nascum Plus and ACC
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.
Drug: Nascum Plus
nasal application of nascum plus

Other: ACC
4 hours challenge to grass pollen in the allergen challenge chamber (ACC)




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772405


Locations
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Germany
Fraunhofer ITEM
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
M et P Pharma AG
Investigators
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Principal Investigator: Philipp Badorrek, MD Fraunhofer-Gesellschaft
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Responsible Party: Philipp Badorrek, Head of Department, Principle Investigator, Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03772405    
Other Study ID Numbers: 18-05 NAPO
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases