A RANDOMIZED, BLINDED, CROSSOVER TRIAL OF A SINGLE DOSE OF ORAL L-DOPS 300 MG IN AN ENVIRONMENTAL EXPOSURE UNIT IN SUBJECTS WITH SEASONAL ALLERGIC RHINITIS - L-DOPS in SAR
- Conditions
- seasonal allergic rhinitisMedDRA version: 7.0Level: LLTClassification code 10039776
- Registration Number
- EUCTR2004-002708-13-DE
- Lead Sponsor
- Synergia Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1.Male or female, 18 to 50 years of age with a history of seasonal allergic rhinitis.
2. The subject is otherwise healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by the investigator based on the patients medical history, physical examination, laboratory or other tests.
3.Subject exhibits a moderate response up to 4.000 Dactylis glomerata pollen grains/m3 during 2 hours in the environmental exposure unit, which is defined as a Total Nasal Symptom Score of at least 6. (TNSS is the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3).
4.Positive skin prick test (wheal difference D. glomerata – negative control = diameter 3mm) for Dactylis glomerata pollen at or within the 12 months preceding the screening visit.
5.Baseline FEV1 >= 80% predicted and a baseline FEV1 (maximum recorded value) / FVC (minimum recorded value) >= 70% predicted using standardized Lung Function Testing guidelines produced by European Community for Coal and Steel (ECCS).
6.Total Nasal Symptom Score (TNSS) of <= 3 and a score < 2 for each symptom, i.e. obstruction, rhinorrhea, itch, and sneeze prior to each medication.
7.Absence of conditions or factors, which would make the subject unlikely to be able to stay in the environmental exposure unit (EEU) for 5 hours.
8.Willingness and ability of giving informed consent, which includes compliance with the requirements and restrictions, listed in the consent form.
9.Availability to complete all study measurements
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)
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1.Pregnant or nursing females.
2.Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the Section below (Contraception) from at least two weeks prior to the first dose of study medication; and to continue until the final pregnancy test has been performed (not less than 72 hours after treatment).
3.On examination the subject is found to have any structural nasal abnormalities or nasal polyps, a history of frequent nose bleeding, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the Physician responsible opinion renders the subject unsuitable for participation in the study.
4.Presence of any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
5.The subject is likely to be unable to abstain from Salbutamol use for 8 hours before a challenge.
6.The subject has a history of drug, other allergy or history of severe anaphylactic reaction that, in the opinion of the responsible physician, contraindicates the study participation.
7.The subject has known allergic reactions or intolerance to L-DOPS (DOPS® (Droxidopa), Sumitomo Pharmaceuticals, Inc.), Pseudoephedrine, or lactose.
8.The subject has current diagnosis of heart disease, hypertension, hyperthyroidism, diabetes, glaucoma, moderate to severely decreased kidney function or phaeochromocytoma.
9.The subject is concurrently participating or has participated in a clinical study in the previous 1 month in which the subject was or will be exposed to an investigational or a non-investigational drug or device.
10.The subject has a screening QTc value of > 430ms (> 450ms for females), PQ interval outside the range 120 to 240ms or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave).
11.The subject has donated a unit of blood (450mL) within the previous 3 months or intends to donate within 3 months of completing the study.
12.The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, and herbal remedies (e.g. St. John’s Wort). Paracetamol and occasionally needed short-acting-beta-agonists are permitted.
13.The uses of monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants in the last two weeks before study begin.
14.The use of any other drug prior to treatment with the study drugs, which could interfere with the evaluation of safety or efficacy.
15.The subject regularly, or on average, drinks more than 4 units of alcohol per day - where 1 unit = ½ pint of beer (284mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
16.The subject is at risk of non-compliance with the study procedures/restrictions.
17.The use of long-acting antihistamines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of a single dose of 300 mg L-DOPS on nasal congestion, nasal symptoms, nasal flow, nasal airways and nasal secretion provoked by spending 5 hours in an environmental exposure unit 2 hours after dosing.<br><br>;Secondary Objective: To evaluate the safety and tolerability, and pharmacokinetics of a single dose of 300 mg L-DOPS in subjects with mild to moderate allergic rhinitis.;Primary end point(s): Primary efficacy parameter:<br>Weighted mean of the Nasal Obstruction Symptom Score (NOSS) 2-7h post-dose period spent in an environmental exposure unit.<br>
- Secondary Outcome Measures
Name Time Method