Avanz Phleum Pratense Maintenance Dose
Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliImekamilika
Wadhamini
ALK-Abelló A/S
JARIBIO LA KLINIKI: NCT01438827
BioSeek: NCT01438827
Maneno muhimu
Kikemikali
The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.
Tarehe
| Imethibitishwa Mwisho: | 12/31/2013 |
| Iliyowasilishwa Kwanza: | 09/12/2011 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 09/20/2011 |
| Iliyotumwa Kwanza: | 09/21/2011 |
| Sasisho la Mwisho Liliwasilishwa: | 01/19/2014 |
| Sasisho la Mwisho Lilichapishwa: | 01/21/2014 |
| Tarehe halisi ya kuanza kwa masomo: | 08/31/2011 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 11/30/2012 |
| Tarehe ya Kukamilisha Utafiti: | 12/31/2012 |
Hali au ugonjwa
Allergic Rhinoconjunctivitis
Uingiliaji / matibabu
Drug: Avanz Phleum pratense
Drug: Injection with no active grass component
Awamu
Awamu 2/Awamu 3
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: Avanz Phleum pratense 15,000 SQ+ | |
| Active Comparator: Avanz Phleum pratense 4,000 SQ+ | |
| Placebo Comparator: Injection with no active grass component | Drug: Injection with no active grass component Suspension for Injection, Every 6 weeks for one year |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - A history of grass pollen allergy - Positive skin prick test to grass - Positive Immunoglobulin E test to grass Exclusion Criteria: - Other allergies overlapping the grass pollen season - Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment) |
Matokeo
Hatua za Matokeo ya Msingi
1. Recording of rhinoconjunctivitis symptoms [Daily recordings during the grass pollen season 2012]
2. Recording of symptomatic allergy medication use [Daily recordings during the grass pollen seasons 2012]
