Immunological Effects From Intranasal Chitin Micro-Particles (INCA)

This study has been completed.
Sponsor:
Collaborator:
CMP Therapeutics Ltd
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01508039
First received: October 24, 2011
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

The purpose of the study is:

  • To investigate whether chitin can effect healthy adults, the nasal mucosa in a direction that will enhance the immune response to infection
  • To investigate whether chitin influence of the nasal mucosa is well tolerated, and that there is no inflammation, as it seen with exposure to endotoxin.

Condition Intervention
Healthy
Other: Chitin Micro Particle

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Double-blind,Single-dose,Placebo and Single-blind Active Controlled Cross-over Study in Healthy Volunteers to Access in Effects of Intranasal Chitin Micro-particles on the Release of Cytokines From Nasal Mucosa

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Changes in levels of cytokines in nasal lavage fluid compared with dosing with placebo. [ Time Frame: Period 1, day 0. Period 2, day 14 ] [ Designated as safety issue: No ]
    Change in levels of cytokines (TNF-alfa, IFN-gamma, IL-1b, IL-4 IL5, IL, 6, IL-8, IL-10 and IL-13) in nasal lavage fluid compared to dosing with placebo.


Secondary Outcome Measures:
  • Changes in levels of cytokines in nasal lavage fluid compared with dosing with active control. [ Time Frame: Day0, day 14,day 28. ] [ Designated as safety issue: No ]
    Changes in levels (maximum concentration) of TNF-alfa, IFN-gamma, IL-1b, IL-4, IL5, IL-6, IL-8, IL-10 and IL-13 in nasal lavage samples following intranasal dosing with cmp compared to lipopolysaccharide active control.

  • Change from baseline. [ Time Frame: Day 0, day 14, day 28 ] [ Designated as safety issue: No ]

    The total eosinophil counts and cysteinyl leukotriene concentration in nasal lavage fluid following intranasal dosing with cmp.

    Total nasal symptom scores at 4 and 8-hours following intranasal dosing with cmp.


  • Safety check. [ Time Frame: Day0, day14, day 28. ] [ Designated as safety issue: Yes ]
    Safety will be assessed using the adverse events, vital signs and nasal acoustic rhinometry following dosing with cmp versus placebo.


Enrollment: 14
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with chitin micro-particles
The study will involve 14-healthy subjects confirming to the inclusion criteria randomised to the treatments.
Other: Chitin Micro Particle

The total spray volume for each application is 0.4 ml equivalent to a total single-dose for chitin of 2 mg (0.5 mg per 0.1 ml spray).

A total single-dose for LPS, of 2 mg of endotoxin from Enterobacter agglomerans (0.5 mg per 0.1 ml spray)

Other Name: Chitin micro-particle

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• healthy non-smoking male or female volunteers between 18 and 30 years of age, inclusive (at screening).

Subjects:

  • asymptomatic at screening as characterized by normal appearing nasal mucosa with no active allergic rhinitis.
  • be free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, neurological and psychiatric disease as determined by medical history, physical examination and screening investigations.
  • with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
  • capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • be available to complete the study.
  • satisfy a medical examiner about their fitness to participate in the study.
  • provide oral and written informed consent to participate in the study.

Exclusion Criteria:

Subjects with:

  • atopy
  • perennial rhinitis.
  • upper respiratory tract infection within 2 weeks of the first dose of study medication.
  • medical conditions likely to affect the outcome of the study in the opinion of the investigator.
  • nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
  • presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as ≥ 80% predicted for height and age, "Danish Society of Lung Physicians 1986").
  • a history of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
  • any infirmity, disability, or geographic location which, in the opinion of the chief investigator, would limit compliance with the protocol.
  • infection of the upper airways/lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and at the start of/or during the treatment period.
  • subjects with inability to tolerate lavage correctly with a preliminary nasal lavage at screening.
  • participation in a study with a new molecular entity during the previous four months or any other trial during the previous three months.

Subjects who/with:

  • regularly, or on average, drink more than four units of alcohol per day.
  • are in receipt of prescribed or over the counter medication (including herbal remedies and dietary supplements) within 14 days of the first dose of test article and for the duration of the trial (with the exception of paracetamol up to 2g daily). In particular, all antihistamines, chromoglycate and steroids are prohibited during this period.
  • inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function).
  • have donated 450 mL or more blood within the previous 12 weeks.
  • clinical features suspicious of tuberculosis - weight loss, haemoptysis pyrexia, purulent sputum, previous abnormal chest X-ray will be excluded from the study.
  • clinical evidence of autoimmune disease.
  • with allergy to seafood or any of the excipients in the study drug formulation.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508039

Locations
Denmark
Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
CMP Therapeutics Ltd
Investigators
Principal Investigator: Torben Sigsgaard, Professor Aarhus University, School of Public Health, Dept of Environmental & Occupational Medicine
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01508039     History of Changes
Other Study ID Numbers: CMP-001-008
Study First Received: October 24, 2011
Last Updated: January 25, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Intranasal
Chitin Micro-particles
Immunological Effects
Nasal mucosa
Cytokines
Immunological Effects from Intranasal Chitin Micro-Particles

ClinicalTrials.gov processed this record on October 19, 2014