|- candidate number||16700|
|- NTR Number||NTR4459|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mrt-2014|
|- Secondary IDs||NL471430283 METC |
|- Public Title|| The CiSAR Study
|- Scientific Title||Efficacy and tolerability of Citrus/Cydonia comp.
solution for injection in patients with grass pollenseasonal allergic rhinitis:
Randomised, double-blind, placebo-controlled comparative clinical trial with three parallel treatment groups
The CiSAR Study |
|- hypothesis||Hypothesis 1: There is a difference of at least 30% in mean “days with symptom control” between the Citrus/Cydonia comp. 1% verum group compared to the placebo group in the last two weeks of treatment in favour of Citrus/Cydonia comp. 1% solution for injection.
Hypothesis 2: There is a difference of at least 15% in mean “days with symptom control” between the Citrus/Cydonia comp. 1-5% verum group compared to the Citrus/Cydonia comp. 1% verum group in the last two weeks of treatment in favour of Citrus/Cydonia comp. 1-5% solution for injection.
Hypothesis 3: There is a statistically significant difference in the use of rescue medication during the whole treatment period between the verum and the placebo group in favour of Citrus/Cydonia comp. 1% solution for injection and Citrus/Cydonia comp. 1-5% solution for injection.
Hypothesis 4: There is a statistically significant difference in the number of drop outs between the verum and the placebo group in favour of Citrus/Cydonia comp. 1% solution for injection and Citrus/Cydonia comp. 1-5% solution for injection.
|- Healt Condition(s) or Problem(s) studied||Grass pollen allergy, Allergic rhinitis, Hay fever|
|- Inclusion criteria||1. Written informed consent
2. Age ≥ 18 and < 60 years
3. Seasonal allergic rhinitis:
- Duration of respective complaints at least 2 years
- Suffering from the following nasal symptoms: sneezing, itching nose, nasal obstruction and
watery nasal discharge
- Severity score of at least two of the four nasal symptoms ≥ 2 (ranging from 0 = not present to 3= severe)
- Suffering from the following non-nasal symptoms: itchy/burning eyes, watery eyes, redness of eyes and itching ears/throat
- Severity score of at least two of the four non-nasal symptoms ≥ 2 (ranging from 0 = not present to 3 = severe)
- The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for at least two previous years
- Average Total Symptom Score in the wash-out period ≥ 9 on days with a pollen count > 20 or use of rescue medication on days with a pollen count > 20.
|- Exclusion criteria||1. Chronic inflammatory autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn’s disease
2. Known hypersensitivity to one of the constituents of Citrus/Cydonia comp.
3. Participation in a further clinical trial at the same time or within the previous 4 weeks prior to enrolment into this study
4. Previous use of medicinal products containing Citrus and/or Cydonia
5. Pregnancy or lactation
6. Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
7. A known history of drug, alcohol and/or medication dependence or addiction
8. Immunotherapy in the last two years
9. Use of cromoglycates
10. Other allergies (non seasonal allergies)
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2014|
|- planned closingdate||1-mrt-2015|
|- Target number of participants||120|
|- Interventions||Subcutaneous injections|
|- Primary outcome||Days with symptom control” defined by:
a) A Total Symptom Score of ≤ 8 (while exposed to a mean pollen count of 20-50) or ≤ 12 (while exposed to a mean pollen count of > 50)
b) No use of rescue medication
in the verum groups compared to the placebo group in the last two weeks of treatment
|- Secondary outcome||1. Total use of rescue medication throughout the whole treatment period.
2. Number of drop outs between verum groups and placebo group.
3. Safety: Adverse events.
4. “Days with symptom control” in the verum groups compared to the placebo group in the third and fourth weeks of treatment or the fifth and sixth weeks of treatment in case of extended treatment.
|- Timepoints||Visit 1 (week -3/-2/day -3): Enrolment, duration wash-out depending on previously used medication
Visit 2 (week 0/day 0): Baseline scores, intervention
Visit 3 (week 3 (& week5*): Telephone check
Visit 4 (week 6/ week 8*): Symptom scores
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. E.T. Kok|
|- CONTACT for SCIENTIFIC QUERIES||Dr. E.T. Kok|
|- Sponsor/Initiator ||Hogeschool Leiden, Lectoraat Antroposofische Gezondheidszorg|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||7-mrt-2014 - 11-apr-2014|