Seasonal Allergic RhinitisPhase 1/2NCT00443495
Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis
A Phase 1/2 study testing Chitin microparticles by nasal route in people with Seasonal Allergic Rhinitis, run by CMP Therapeutics Ltd.
Trial summary
Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled allergic rhinitis to be effective against a wide range of common respiratory allergens. It is an immuneenhancer. The primary purpose of the study is to demonstrate safety in a first into man study on 24 human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Chitin microparticles by nasal route
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Mar 2007
- Phase
- Phase 1/2
- 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 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males aged 18 to 50 years of age inclusive with a history of symptoms of allergic rhinitis within the previous two years.
- Subjects must be free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
- Forced expiratory volume over one second (FEV1) within normal limits (≥ 90% of predicted, ECCS 1993).
- Asymptomatic at screening as characterized by:
- Normal appearing nasal mucosa with no active allergic rhinitis.
- A pre-nasal allergen challenge total nasal symptom score sheet on study entry so that subjects produce a score of <2 at screening.
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- Non smokers for at least the past 12 months with a pack history ≤ 1 pack years (Pack years = (n of cigarettes smoked/day/20) x n of years smoked).
- An increase in nasal symptom score of between 4 and 10 following screening nasal allergen challenge.
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Available to complete the study.
- Negative urinary drugs of abuse screen, determined at screening and in the 24 hours before the first dose of study medication.
- Negative carbon monoxide test (smokerlyzer) determined at screening and in the 24 hours before the first dose of study medication.
- Clinically normal vital signs and 12-lead electrocardiogram (ECG), determined at screening.
- A body mass index (Quetlet index) in the range of 18.00 to 30.9.
Who cannot join
- 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 ≥ 90% predicted for height and age, ECCS 1993).
- 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.
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- Any infirmity, disability, or geographic location which, in the opinion of the principal 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 the treatment period.
- Clinically significant abnormality in clinical laboratory tests at screening as determined by the principal investigator.
- 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.
- The subject regularly, or on average, drinks more than four units of alcohol per day.
- Testing positive for hepatitis C antibody or hepatitis B surface antigen or for HIV.
- 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).
- Donation of 450 mL or more blood within the previous 12 weeks.
- A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
- Subjects with clinical features suspicious of tuberculosis - weight loss, pyrexia, haemoptysis, purulent sputum, previous abnormal chest X-ray will be excluded from the study.
- Clinical evidence of autoimmune disease.
- Allergy to seafood.
About this study
Official title: First Into Man Administration of Chitin Microparticles: a Randomised,Double Blind,Placebo Controlled Parallel Group Upward Titration Evaluation of 3 Dose Levels Given Intr-Nasally Over 24 Hours,Followed by a Placebo Controlled,Randomised Parallel Group Evaluation of Safety and Biological Activity Over 7 Days in Subjects Suffering From Allergic Rhinitis
Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled allergic rhinitis to be effective against a wide range of common respiratory allergens. It is an immuneenhancer.
The primary purpose of the study is to demonstrate safety in a first into man study on 24 human volunteers. The secondary objective is to demonstrate efficacy by chosing subjects that demonstrate a response to a nasal allergen challenge using grass pollen.
The subjects are being given increasing doses of CMP, supplied as a nasal spray, for 7 days followed by a nasal allergen challenge with Timothy Grass Pollen extract. Over this period nasal symptom scores, eosinophil counts and cytokine measurements will be performed.
Read the detailed description
Chitin microparticles are a special preparation of chitin. This a long chain polysaccaride derived from shells of the North Atlantic shrimp. CMP acts a an immunenhancer which improve immune function by stimulating macrophages and other cells such as T-helper lymphocytes, (Th cells). In allergies there is an imbalance between Th1 and Th2 cells. Imuneenhancers shift the balance in favour of Th1 cells. The immunomodulatory properties of CMP have been demonstrated in animal models against a wide range of respiratory allergens. There have been no indications of toxic side effects in animal models.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Chitin microparticles by nasal route
- 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.
Chitin microparticles by nasal routeDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startOct 2006
- Study completionMar 2007
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- CMP Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven J Warrington, MA MD FRCP FFPM, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443495
- Sponsor's protocol ID
- CMP/01/006
- Other IDs
- 06-505
- Status last verified
- Mar 2007
- First submitted
- 2 Mar 2007
- Last updated
- 6 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Into Man Administration of Chitin Microparticles: a Randomised,Double Blind,Placebo Controlled Parallel Group Upward Titration Evaluation of 3 Dose Levels Given Intr-Nasally Over 24 Hours,Followed by a Placebo Controlled,Randomised Parallel Group Evaluation of Safety and Biological Activity Over 7 Days in Subjects Suffering From Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00443495
- Acronym / sponsor ID
- CMP/01/006
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- CMP Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Mar 2007
- First posted
- 6 Mar 2007 (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.
Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled allergic rhinitis to be effective against a wide range of common respiratory allergens. It is an immuneenhancer.
The primary purpose of the study is to demonstrate safety in a first into man study on 24 human volunteers. The secondary objective is to demonstrate efficacy by chosing subjects that demonstrate a response to a nasal allergen challenge using grass pollen.
The subjects are being given increasing doses of CMP, supplied as a nasal spray, for 7 days followed by a nasal allergen challenge with Timothy Grass Pollen extract. Over this period nasal symptom scores, eosinophil counts and cytokine measurements will be performed.
Detailed description
Chitin microparticles are a special preparation of chitin. This a long chain polysaccaride derived from shells of the North Atlantic shrimp. CMP acts a an immunenhancer which improve immune function by stimulating macrophages and other cells such as T-helper lymphocytes, (Th cells). In allergies there is an imbalance between Th1 and Th2 cells. Imuneenhancers shift the balance in favour of Th1 cells. The immunomodulatory properties of CMP have been demonstrated in animal models against a wide range of respiratory allergens. There have been no indications of toxic side effects in animal models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Males aged 18 to 50 years of age inclusive with a history of symptoms of allergic rhinitis within the previous two years.
- Subjects must be free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
- Forced expiratory volume over one second (FEV1) within normal limits (≥ 90% of predicted, ECCS 1993).
- Asymptomatic at screening as characterized by:
- Non smokers for at least the past 12 months with a pack history ≤ 1 pack years (Pack years = (n of cigarettes smoked/day/20) x n of years smoked).
Key exclusion criteria (20 listed)
- 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 ≥ 90% predicted for height and age, ECCS 1993).
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 |
|---|---|---|
| Chitin microparticles by nasal route | Drug | – |
Primary outcome
Not reported in the source record.
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 6 Mar 2007.
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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.
Steven J Warrington, MA MD FRCP FFPM principal investigator
Hammersmith Medicines Research
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chitin microparticles by nasal route in people with Seasonal Allergic Rhinitis, run by CMP Therapeutics Ltd.
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 14 inclusion and 20 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 6 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 6 Mar 2007.