A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Birch Given With a Rush Up-dosing Regimen to Patients With Allergic Rhinitis/Rhinoconjunctivitis

This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).
The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes.
A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.

Start Date01 Sep 2013

Sponsor / Collaborator

HAL Allergy Holding BV

[+1]

NCT01438463 / CompletedPhase 2

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Dose Range Finding Study to Identify the Optimal Dose of PURETHAL® Mites SCIT in Patients With House Dust Mites-induced Persistent Allergic Rhinitis/Rhinoconjunctivitis

The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety.
For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.

Start Date01 Sep 2011

Sponsor / Collaborator

HAL Allergy Holding BV

EUCTR2011-000393-61-BE / Not yet recruitingPhase 2

A multi-centre, randomized, double-blind, placebo-controlled, dose range finding study to identify the optimal (i.e. safe and effective) dose of PURETHAL® Mites SCIT in patients with house dust mites-induced persistent allergic rhinitis/rhinoconjunctivitis. - PURETHAL® Mites Dose Range Finding study in patients with persistent allergic rhinitis/rhinoconjunct

Start Date05 Aug 2011

Sponsor / Collaborator-

100 Clinical Results associated with House dust mite allergy vaccine(HAL Allergy Holding BV)

100 Translational Medicine associated with House dust mite allergy vaccine(HAL Allergy Holding BV)

100 Patents (Medical) associated with House dust mite allergy vaccine(HAL Allergy Holding BV)

Literatures (Medical) associated with House dust mite allergy vaccine(HAL Allergy Holding BV)

01 Jan 2014·International Archives of Allergy and ImmunologyQ3 · MEDICINE

Assessing the Efficacy of Immunotherapy with a Glutaraldehyde-Modified House Dust Mite Extract in Children by Monitoring Changes in Clinical Parameters and Inflammatory Markers in Exhaled Breath

Q3 · MEDICINE

Article

Author: Cruz, Maria-Jesus ; Lozano, Jaime ; Piquer, Monica ; Giner, Maria-Teresa ; Plaza, Ana Maria

INTRODUCTIONThe aim of this study was to evaluate the effectiveness of specific immunotherapy (SIT) management with allergoids in children with allergic asthma by monitoring changes in clinical parameters and inflammatory markers in exhaled breath.METHODSThe study population included 43 patients (24 males) of 6-14 years of age, who had allergic asthma and were sensitized to mites. Twenty-three individuals were treated with subcutaneous SIT (PURETHAL® Mites, HAL Allergy) for 8 months, i.e. the SIT group, and 20 were given medication to treat symptoms only, i.e. the control group. Before treatment and after 4 and 8 months, several clinical parameters, the levels of exhaled nitric oxide and the pH of exhaled breath condensate (EBC) were determined.RESULTSThe SIT group presented with an improvement in asthma classification, a reduction in maintenance drug therapy and improved scores on the quality-of-life questionnaire. These changes were not observed in the control group. Both groups presented significant decreases in EBC pH values at 4 and 8 months after treatment compared to at baseline. However, analysis of the variable 'ratio' showed an increase in the EBC pH values after 8 months of treatment in the SIT group compared with the values at 4 months.CONCLUSIONSSIT with standardized mite extract reduces asthma symptoms in children. A decrease in EBC pH values was observed in both groups, although the SIT group presented a tendency of recovered values after 8 months. Future studies of EBC pH monitoring in the longer term are needed to determine the effectiveness of this marker.

100 Deals associated with House dust mite allergy vaccine(HAL Allergy Holding BV)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Conjunctivitis, Allergic	DE	HAL Allergy Holding BV	01 Jan 2011
Rhinitis, Allergic	DE	HAL Allergy Holding BV	01 Jan 2011

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
House dust mite allergy	Phase 2	DE	HAL Allergy Holding BV	01 Sep 2011
House dust mite allergy	Phase 2	BE	HAL Allergy Holding BV	01 Sep 2011
House dust mite allergy	Phase 2	NL	HAL Allergy Holding BV	01 Sep 2011
House dust mite allergy	Phase 2	AT	HAL Allergy Holding BV	01 Sep 2011
House dust mite allergy	Phase 2	ES	HAL Allergy Holding BV	01 Sep 2011
Rhinitis, Allergic	Phase 2	NL	HAL Allergy Holding BV	01 Sep 2011
Rhinitis, Allergic	Phase 2	AT	HAL Allergy Holding BV	01 Sep 2011
Rhinitis, Allergic	Phase 2	BE	HAL Allergy Holding BV	01 Sep 2011
Rhinitis, Allergic	Phase 2	ES	HAL Allergy Holding BV	01 Sep 2011
Rhinoconjunctivitis	Phase 2	NL	HAL Allergy Holding BV	01 Sep 2011

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