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NCT00367640 Clinical Trial

Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Allergy Clinical Trial

Official title:
Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00367640
Other study ID # VO34.04
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 22, 2006
Last updated October 8, 2009
Start date November 2004
Est. completion date August 2005

Study information
Verified date October 2009
Source Stallergenes
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Social Security and GenerationsBulgaria: Ministry of Health, Executive Drug AgencyCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS)Germany: Federal Institute for Drugs and Medical Devices (BfArM)Hungary: National Institute of PharmacyItaly: Agenzia Italiana del FarmacoSlovakia: State Institute for Drug ControlSpain: Agencia Espanola del Medicamento y Productos Sanitaros
Study type Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Written consent

- Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.

- Sensitised to grass pollen (positive SPT and RAST level of at least class 2).

- Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.

- Safety laboratory resuts within the references ranges

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Sublingual immunotherapy tablets - grass pollen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Stallergenes

Outcome
Type Measure Description Time frame Safety issue
Primary • To assess the efficacy of SLIT on the Rhinoconjunctivitis Total Symptom Score (RTSS)
Secondary Rescue medication usage.
Secondary 6individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS).
Secondary Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score.
Secondary Global evaluation by the patient.
Secondary To document the safety of the treatment
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