Investigation of Efficacy and Safety of Ragweed MATAMPL, Pollinex-R and Placebo in Patients With Ragweed Allergy

This study has been completed.
Sponsor:
Information provided by:
Allergy Therapeutics
ClinicalTrials.gov Identifier:
NCT00110786
First received: May 13, 2005
Last updated: June 16, 2010
Last verified: September 2009
  Purpose

Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of the pollen season.

In this study, the safety and efficacy of Ragweed MATAMPL will be assessed by exposing allergic subjects to Ragweed pollen in an environmental exposure chamber (EEC). Patient symptomatic response to pollen and patient quality of life in the EEC will be determined.


Condition Intervention Phase
Type I Hypersensitivity
Biological: Ragweed MATAMPL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double Blind Study to Investigate the Clinical Efficacy and Safety of Ragweed MATAMPL (Allergy Therapeutics®), Pollinex®-R (Allergy Therapeutics®) and Placebo in Patients With Seasonal Allergic Rhinitis With Ragweed Allergy, in an Environmental Exposure Chamber (EEC) Model, With Follow-Up During a Natural Ragweed Pollen Season

Resource links provided by NLM:


Further study details as provided by Allergy Therapeutics:

Primary Outcome Measures:
  • Assessment of the clinical efficacy of Ragweed MATAMPL versus placebo in reducing seasonal allergic rhinitis (SAR) symptoms caused by ragweed pollen in an Environmental Exposure Chamber (EEC) Model

Secondary Outcome Measures:
  • Comparison of the efficacy of Pollinex-R (modified Ragweed Tyrosine adsorbate) versus placebo in reducing SAR symptoms caused by ragweed pollen in an EEC Model
  • Assessment of the immunological response to Ragweed MATAMPL, Pollinex-R, versus placebo immunotherapy in patients with SAR
  • Evaluation of the impact of Ragweed MATAMPL and Pollinex-R versus placebo on quality-of-life in patients with SAR using the Rhinoconjunctivitis Quality of Life Questionnaire for use in the Environmental Exposure Chamber (RQLQ-EEC)
  • Assessment of the safety and tolerability of Ragweed MATAMPL and Pollinex-R versus placebo in patients with SAR

Estimated Enrollment: 240
Study Start Date: May 2005
Estimated Study Completion Date: December 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least a 2-year clinical history of seasonal allergic rhinitis
  • allergy to a ragweed allergen, defined by positive case history and positive skin prick test
  • Specific IgE for ragweed as documented by a radioallergosorbent test (RAST), or equivalent test, with class >= 2
  • minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure at both Visits 4 and 5.
  • Patients must observe drug washout times listed in the protocol prior to Screening.
  • Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile
  • Females of childbearing potential should be using acceptable birth control methods
  • Patients who are normally active and otherwise judged to be in good health
  • Patients must be willing and able to give written informed consent and must provide this consent
  • Patients must be willing and able to attend required study visits
  • Patients must be able to follow instructions

Exclusion Criteria:

  • Symptomatic for allergic rhinitis or allergic conjunctivitis from allergy to grass or trees
  • Symptomatic for significant perennial rhinitis
  • Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications
  • Concurrent use of any prohibited medication(s) or inadequate washout of medication
  • Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, or potent or super-potent topical corticosteroids
  • Chronic use of long acting antihistamines and other concomitant medications that would affect assessment of the effectiveness of study drug(s)
  • Any systemic disorder that could interfere with the evaluation of the study medication(s)
  • Upper or lower respiratory infection requiring antibiotics within 14 days of the first Baseline EEC Visit
  • Diagnosis of sinusitis within 30 days of the first Baseline EEC Visit
  • Any ocular disorder (other than allergic conjunctivitis) which could interfere with the evaluation of the study medication
  • Hypersensitivity to the study drug excipients
  • active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections or parasitic or ocular herpes simplex
  • nasal septal ulcers, nasal surgery or nasal trauma within 90 days of enrollment
  • Clinical history of anaphylaxis
  • Patients with contraindications for allergy vaccines
  • Clinical history of immunodeficiency, including immunosuppressant therapy
  • Patients in whom tyrosine metabolism is disturbed
  • Patients with contraindications to adrenaline
  • Subject is taking β-blockers
  • Current diagnosis of chickenpox or measles
  • Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study
  • Clinical history of severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could be expected to interfere with the study
  • Clinical history, or evidence, of nasolacrimal drainage system malfunction
  • Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol
  • Patient that has received Ragweed MATAMPL in any previous clinical trial
  • History of immunotherapy with ragweed pollen extract
  • Patient received treatment with preparation containing MPL during the past 12 months
  • Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study
  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: NCT00110786

Locations
Canada, Ontario
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Allergy Therapeutics
Investigators
Principal Investigator: Deepen Patel, MD Allied Research International Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00110786     History of Changes
Other Study ID Numbers: RagweedMATAMPL204, P2DP05001
Study First Received: May 13, 2005
Last Updated: June 16, 2010
Health Authority: Canada: Health Canada

Keywords provided by Allergy Therapeutics:
Allergy
Specific Immunotherapy
Ragweed
Environmental Exposure Chamber

Additional relevant MeSH terms:
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014