| DEC-NET Serial number GB329 |
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| Published online | 20/10/2004 14.16.00 |
| Last updated | 02/08/2005 10.56.29 |
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| This trial has been approved by an ethics committee |
| Current trial status | Closed to recruitment of participants: follow-up continuing |
First subject enrolment
Target N. of subjects |
01/2002
N/A |
Major Disease
(ICD9 class) | CHR ALLRG CONJUNCTIV NEC |
| Experimental drug |
Phleum Pratense
Treatment regimen (dosage and duration)
Updosing phase lasting 10 visits then maintenance phase of 10 000 SQ iu sc 6 weekly (+/-2 weeks)for 3 years |
| Gender | Both |
| Age (range) | 5-17 |
Eligibility criteria |
| Inclusion criteria |
| Seasonal allergic rhinoconjunctivitis not controlled by pharmacotherapy, positive SPT and/or SpIgE to Phleum Pratense |
| Exclusion criteria |
| Significant perennial asthma, chronic use of orally inhaled steroids, receiving therapy with agents known to interact with adrenaline, pregnant |
Trial design/methodology |
| Phase | 3 |
| Kind of study | Safety
|
| Design | Open label safety evaluation |
| Purpose of study |
| To evaluate the clinical safety of specific immunotherapy with Alutard SQ Grass Pollen in the dose 100 000 sq |
| Primary outcomes |
| Safety evaluation |
| Secondary outcomes |
| Adverse events |
| Summary of study design, objectives, and ongoing research findings |
| An open label, non-controlled, multi-centre evaluation of specific immunotherapy with Alutard Grass Pollen 100.000 SQ-U/ml in children aged 5-17 years with seasonal allergic rhinitis due to grass pollen not responding to anti-allergic drugs. Participating centres must be confident to administer immunotherapy and must have facilities for cardiopulmonary resuscitation immediately available. |
