A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL MICROENCAPSULATED RAGWEED POLLEN EXTRACT ADMINISTERED PRIOR TO AND DURING THE RAGWEED POLLEN SEASON - RPE 04
- Conditions
- Treatment of seasonal allergic rhinitis to ragweed pollen.
- Registration Number
- EUCTR2006-005713-35-HU
- Lead Sponsor
- Curalogic A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
Inclusion Criteria:
Subjects eligible for enrollment into this study are female and males who:
1.Are between 18 and 65 years of age and are in general good health;
2.Have a history of two consecutive seasons of fall, seasonal allergic rhinitis that has required repeated treatment with antihistamines, leukotriene antagonists, and/or nasal steroids;
3.Have a positive puncture skin test to a standardized ragweed (Ambrosia artemisiifolia) pollen extract (= 250 Amb a 1 units/ml) with a:
•Sum of erythema: of at least 40 mm, and
•Diameter of wheal of at least 5 mm;
4.Have a ragweed (Ambrosia artemisiifolia) specific IgE level of at least 0.7 kU/L using the Pharmacia & Upjohn ImmunoCAP assay;
5.Are willing to remain in the study center’s defined ragweed area for the entire pollen season;
6.Will be available for clinic visits for the duration of the study;
7.Have a negative urine pregnancy test (women of childbearing potential). In women of childbearing age, who are sexually active, they must be consistently using a highly effective method of birth control (oral contraceptive, intra-uterine device [IUD], condom plus spermicide, Depo-Provera or other acceptable contraceptive methods, [abstinence and celibacy will be accepted only with written confirmation by subject]) for at least one month prior to study entry and will continue to use this method consistently for the duration of the study;
8.Are able to understand the protocol and comply with study instructions.
9.Have access to phone line (US sites) or wireless capability (European sites) to transmit electronic diary information.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Are pregnant and/or breast feeding;
2.Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the efficacy or the safety of the study medication or might place the subject at additional risk;
3.Have perennial or structurally related rhinitis, including vasomotor rhinitis, that will interfere with the evaluation of symptoms due to ragweed allergy i.e. require treatment of their allergic symptoms with antihistamines or nasal steroids during the months of December and January;
4.Have a routine sleeping pattern between the hours of approximately 6:00 am to 6:00 pm;
5.Are currently receiving immunotherapy to any allergens and/or have received ragweed immunotherapy within 5 years of the Screening Visit (immunotherapy to other allergens than ragweed discontinued within 90 days of Screening Visit is allowed);
6.Are asthmatic requiring daily controller” medications (inhaled corticosteroids, cromolyn-type drugs, long-acting bronchodilators, leukotriene antagonists) or use rescue medicines” (albuterol or similar short-acting bronchodilators) more than 4 times per week at any time during the year or has a FEV1<80% of the predicted value;
7.Have a history of alcohol or drug abuse during the past 18 months;
8.Use beta-blockers and/or monoamine oxidase (MAO) inhibitors;
9.Repeated or daily use of proton pump inhibitors within 1 week of the Screening Visit (Pre-Seasonal Visit 1) and throughout study;
10.Use prohibited medications or have inadequate washout periods prior to the start of the study. The following medications are prohibited and if taken prior to the study, the indicated wash-out periods are applicable:
•H2-blockers (3 days)
•Anti-IgE medication, e.g., Xolair (6 months)
•Tricyclic antidepressants (14 days)
11.Have presence of significant chronic sinusitis as determined by the Investigator
12.Have rhinitis medicamentosa from excessive use of nasal decongestants (eg: oxymetazoline);
13.Have a severe autoimmune disease, immune deficiency
14.Have a malignant neoplastic disease with current signs of disease
15.History of hypersensitivity to the Study Drug or its excipients (Patients enrolled in this study are expected to be allergic to ragweed). Hypersensitivity to Study Drug means that they have had a previous systemic or severe local reaction to ragweed extract previously used for skin testing or immunotherapy;
16.Have previously received MRPE in a clinical trial;
17.Will travel outside the local ragweed pollen region during the ragweed pollen season (27th August to 31th September (US sites) or 15th August to 19th September (European sites)) for more than 3 consecutive days, or for more than a total of 7 days.
For Europe additional exclusion criteria will be in force
18.Sensitized to Mugwort defined as a Mugwort (Artemisia vulgaris) specific IgE measurement of at least 3.5 kU/L using the Pharmacia & Upjohn ImmunoCAP assay;
19.Sensitized to Alternaria defined as an Alternaria (Alternaria alternata) specific IgE measurement of at least 3.5 kU/L using the Pharmacia & Upjohn ImmunoCAP assay.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method