A phase II-III trial assessing the efficacy and safety of three doses of the ALK HDM tablet in house dust mite allergic subjects

ALK-Abelló A/S0 sites800 target enrollmentMay 31, 2006

Overview

No summary available.

Registry

who.int

Start Date

May 31, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Males and females aged 14 years and above
•A clinical history of house dust mite induced mild to moderate persistent asthma of at least one year prior to trial entry.
•Use of an appropriate amount of inhaled corticosteroid (in accordance with the Gina Guidelines) for the control of the mild to moderate persistent asthma symptoms for a period of 6 month within the past year.
•At randomisation the asthma is considered stable and the intake of budesonide is \<800 mcg/day
•A clinical history consistent with mild to severe house dust mite induced allergic rhinitis for at least one year.
•Positive Skin Prick Test (SPT) response (wheal diameter \>3mm to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
•Positive specific IgE (\>IgE Class 2\) against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
•A documented history of reversible airway obstruction.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:

•FEV1 \< 70% of predicted value with appropriate medication.
•A clinical history of perennial allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites)
•A clinical history of chronic sinusitis
•A clinical history of severe asthma within the last two years prior to screening
•Current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media not an exclusion criterion).
•Treatment by immunotherapy with HDM allergen within the previous 5 years prior to randomisation.
•A clinical history of seasonal allergic astham and/or rhinitis if the seasonal allergen is causing symptoms in the run\-in and/or baseline period.
•Concurrent immunotherapy with other allergens than HDM or previous immunotherapy with other allergens than HDM within the 6 months prior to randomisation.