EUCTR2006-001795-20-GB
Active, Not Recruiting
Phase 1
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 House Dust Mite Tablet
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- IgE mediated House dust mite induced mild to moderate asthma and mild to severe allergic rhinitis.
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 604
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
Not specified
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