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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1. Male or female aged 14 years or above 2. Written informed consent obtained before entering the trial. For subjects aged 14-17 years written informed consent should also be available from parent s /guardian. 3. A clinical history of house dust mite induced mild to moderate persistent asthma1 of at least one year prior to trial entry 4. Use of an appropriate amount of inhaled corticosteroid in accordance with the GINA Guidelines2 for the control of the mild to moderate persistent asthma symptoms for a period of 6 months within the past year. 5. At randomisation the asthma is considered stable and the intake of budesonide is 800 mcg/day 6. A clinical history consistent with mild to severe3 house dust mite induced allergic rhinitis for at least one year. 7. Positive Skin Prick Test SPT response wheal diameter 3 mm to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae 1 Mild to moderate asthma corresponds to Step 2 and 3 in GINA Guidelines 2 See footnote 1 3 The classification of the mild to severe rhinitis symptoms correspond to the mild-severe classification described in the ARIA Guidelines ALK-Abell A/S Confidential 24 April 2006 Group Clinical Development Version 1 Clinical Trial Protocol MT-02 Final Page 24 of 72 8. Positive specific IgE IgE Class 2 against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae 9. A documented history of reversible airway obstruction as judged by an improvement in absolute FEV1 12 or at least 200 ml after administration of short acting beta-2- agonist or an improvement in PEF 15 15-20 minutes after inhalation of a short acting beta-2- agonist or a diurnal variability in PEF 20 when treated with a bronchodilator 10 if not treated or a decrease in PEF 15 after 6 minutes of sustained running or exercise 10. If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate4 contraceptive methods for the duration of the trial
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. FEV1 70 of predicted value with appropriate medication 2. 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 3. A clinical history of chronic sinusitis 4. A clinical history of severe asthma5 within the last two years 5. Current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process serous otitis media is not an exclusion criterion 6. Physical examination with clinically relevant findings 7. Use of an investigational drug within 30 days prior to screening 8. Treatment by immunotherapy with HDM allergen within the previous 5 years 9. History of anaphylactic shock 10. History of angioedema

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

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

Phase 1

ALK-Abelló A/S

Updated 11/25/2019