- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00574704
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy
Studieoversikt
Status
Intervensjon / Behandling
- Legemiddel: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
- Legemiddel: House dust mite allergen extract in combination with CYT003-QbG10-placebo
- Legemiddel: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
- Legemiddel: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens
Exclusion Criteria:
- Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
- Use of any concomitant medication that could affect the patient's study treatment response or assessment results
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
|
subcutaneous injections at 6 visits
|
Placebo komparator: 2
|
subcutaneous injections at 6 visits
|
Eksperimentell: 3
|
subcutaneous injections at 6 visits
|
Placebo komparator: 4
|
subcutaneous injections at 6 visits
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)
Tidsramme: baseline versus 2 months after baseline
|
The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2. |
baseline versus 2 months after baseline
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Safety and Tolerability of the Study Treatment by Collection of Adverse Events
Tidsramme: about 30 min. at each visit
|
about 30 min. at each visit
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Philipp Mueller, MD, Cytos Biotechnology
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CYT005-AllQbG10 03
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