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Immunological Effects From Intranasal Chitin Micro-Particles (INCA)

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. Identifier: NCT01508039
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 26, 2012
CMP Therapeutics Ltd
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Other: Chitin Micro Particle Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Changes in levels of cytokines in nasal lavage fluid compared with dosing with placebo. [ Time Frame: Period 1, day 0. Period 2, day 14 ]
    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 :
  1. Changes in levels of cytokines in nasal lavage fluid compared with dosing with active control. [ Time Frame: Day0, day 14,day 28. ]
    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.

  2. Change from baseline. [ Time Frame: Day 0, day 14, day 28 ]

    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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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


  • 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.

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 identifier (NCT number): NCT01508039

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

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Responsible Party: University of Aarhus Identifier: NCT01508039     History of Changes
Other Study ID Numbers: CMP-001-008
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012
Keywords provided by University of Aarhus:
Chitin Micro-particles
Immunological Effects
Nasal mucosa
Immunological Effects from Intranasal Chitin Micro-Particles