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…
ID
Bron
Aandoening
grass pollenseasonal allergic rhinitis
Hooikoorts (graspollen)
Ondersteuning
Hogeschool Leiden
Cluster Zorg
Zernikedreef 11 (D0.036)
Postbus 382, 2300 AJ LEIDEN
T: +31 71 51 88 769
M: +31 6 468 468 04
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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)
and
b) No use of rescue medication
in the verum groups compared to the placebo group in the last two weeks of treatment
Doel van het onderzoek
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.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Subcutaneous injections
Algemeen / deelnemers
Cluster Zorg
Zernikedreef 11 (D0.036)
Postbus 382
E.T. Kok
Leiden 2300 AJ
The Netherlands
+31 71 51 88 769/+31 6 468 468 04
Wetenschappers
Cluster Zorg
Zernikedreef 11 (D0.036)
Postbus 382
E.T. Kok
Leiden 2300 AJ
The Netherlands
+31 71 51 88 769/+31 6 468 468 04
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4220 |
| NTR-old | NTR4459 |
| CCMO | NL47143.028.13 |
| OMON | NL-OMON40456 |