Clinical trial NCT00633919 (phase 2/phase 3, status: completed)
Conditions: allergy
ICD codes: T78.40XS, T78.49XS, Z91.010, Z91.012, Z91.013, Z91.030, Z91.040
Drugs: salbutamol inhaler, budesonide/formoterol inhaler, prednisone tablet, desloratadine tablet, budesonide nasal spray
SMILES: CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, ClC1=CC2=C(C=C1)C(=C1CCNCC1)C1=C(CC2)C=CC=N1, [H][C@@]12C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  A clinical history of house dust mite induced persistent mild to moderate. asthma,
             with or without concurrent rhinoconjunctivitis, of at least 1 year of evolution.

          -  Demonstration of a positive specific serum IgE test to Dermatophagoides during the
             year prior to the screening visit (CAP Class 2 or higher or equivalent).

          -  Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Dermatophagoides mix.

          -  If pre-menopausal female of childbearing potential, the subject must test negative on
             standard urine pregnancy test.

          -  Willingness to comply with this protocol.

        Exclusion Criteria:

          -  FEV1 < 70% of predicted value with appropriate medication.

          -  Asthma controlled at randomization without need of inhaled corticosteroids or with a
             dose higher than 1000 µg/day of beclometasone or equivalent.

          -  A clinical history of symptomatic perennial allergic asthma caused by allergens to
             which the subjects is regularly exposed (Alternaria, cat), other than house dust
             mites.

          -  Chronic sinusitis.

          -  Aspirin or sulfite intolerance.

          -  Chronic obstructive pulmonary disease.

          -  Current severe atopic dermatitis.

          -  Severe asthma.

          -  Use of an investigational drug within 30 days prior to screening.

          -  Previous immunotherapy with house dust mite allergens for at least 2 years within the
             previous 10 years.

          -  At randomisation, current symptoms of, or treatment for, upper respiratory tract
             infection, acute sinusitis, acute otitis media or other relevant infectious process
             (se-rous otitis media is not an exclusion criterion).

          -  Physical examination with clinically relevant findings.

          -  Any of the following underlying conditions known or suspected to be present: Cystic
             fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal
             or hepatic insufficiency, chronic infection, drug dependency or alco-holism, ischaemic
             heart disease or angina requiring current daily medication or with any evidence of
             disease making implementation of the protocol or interpretation of the protocol
             results difficult or jeopardising the safety of the subject (e.g. clinically
             significant cardiovascular, serious immunopathologic, immunodeficiency whether
             acquired or not, hepatic, neurologic, psychiatric, endocrine, or other ma-jor systemic
             disease).

          -  Immunosuppressive treatment.

          -  A mental condition rendering the subject unable to understand the nature, scope and
             possible consequences of the trial, and/or evidence of an uncooperative attitude.

          -  Unlikely to be able to complete the trial.

          -  Unwillingness to comply with trial protocol regimen for asthma and/or
             rhinoconjunctivitis medication.