Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults
Keywords
Coimriú
Cur síos
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons.
Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.
Dátaí
| Fíoraithe Deireanach: | 03/31/2019 |
| Cuireadh isteach den chéad uair: | 10/10/2006 |
| Clárú Measta Curtha isteach: | 10/10/2006 |
| Arna chur suas ar dtús: | 10/12/2006 |
| Nuashonrú Deireanach Curtha isteach: | 04/10/2019 |
| Nuashonrú Deireanach Postáilte: | 04/15/2019 |
| Dáta Tosaigh an Staidéir Iarbhír: | 03/31/2006 |
| Dáta Críochnaithe Bunscoile Measta: | 04/30/2007 |
| Dáta Críochnaithe an Staid Mheasta: | 02/29/2008 |
Coinníoll nó galar
Idirghabháil / cóireáil
Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Biological: 3
Céim
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| Experimental: 1 TOLAMBA™ dose-intense regimen | |
| Experimental: 2 TOLAMBA™ lower-dose regimen | |
| Placebo Comparator: 3 | Biological: 3 Escalating doses, 6 weekly subcutaneous (under the skin) injections |
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 18 Years Chun 18 Years |
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | Inclusion Criteria: - Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete - Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season Exclusion Criteria: - Has had any hospital admissions for asthma - Has smoked within the past year, or has a ≥10-pack per year smoking history - Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™ - Has used Xolair within the past 12 months - Has a history of anaphylaxis |
Toradh
Bearta Toraidh Príomhúla
1. Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season. [Two years]
