Clinical trial NCT00612118 (phase 2, status: completed)
Conditions: allergic rhinitis, rhinitis, allergic, seasonal
ICD codes: J30.89, J30.9, J30.2, J30.1, J30.5, J30.81, J30.2
Drugs: gsk256066, azelastine hydrochloride
SMILES: COC1=CC=CC(=C1)N=C1C(=CNC2=C1C=C(C=C2C)S(=O)(=O)C1=CC=CC(=C1)C(=O)N(C)C)C(O)=N, COC1=CC=CC(=C1)N=C1C(=CNC2=C1C=C(C=C2C)S(=O)(=O)C1=CC=CC(=C1)C(=O)N(C)C)C(O)=N
Eligibility criteria:

        Inclusion Criteria:

          -  The subject is healthy. Healthy subjects are defined as individuals who are free from
             clinically significant illness or disease as determined by their medical history
             (including family), physical examination, laboratory studies, and other tests.

          -  Male or female between 18 and 50 years inclusive.

          -  A female subject is eligible to participate if she is of:

               -  Non-childbearing potential defined as pre-menopausal females with a documented
                  tubal ligation or hysterectomy; or postmenopausal defined as 12 months of
                  spontaneous amenorrhea [in questionable cases a blood sample with simultaneous
                  follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140
                  pmol/L) is confirmatory].

               -  Child-bearing potential and agrees to use one of the contraception methods listed
                  in Section 8.1 for an appropriate period of time (as determined by the product
                  label or investigator) prior to the start of dosing to sufficiently minimize the
                  risk of pregnancy at that point. Female subjects must agree to use contraception
                  until the end of the study.

          -  Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to
             95.0kg inclusive.

          -  The subject has a history of seasonal allergic rhinitis.

          -  The subject exhibits a moderate response to 1500 grass pollen grains/m3 after 2 hours
             in the Vienna Challenge Chamber, defined as a nasal symptom score of at least 6.
             (Nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of
             which have been scored on a scale from 0 to 3).

          -  The subject has a positive skin prick test (wheal ³ 4mm) for grass pollen at or within
             the 12 months preceding the screening visit.

          -  The subject has a positive RAST (³ class 2) for grass pollen at or within the 12
             months preceding the screening visit.

          -  The subject is a current non-smoker who has not used any tobacco products in the 6
             months preceding the screening visit with a pack history of £ 10 pack years.

          -  The subject must have a baseline FEV1>80% predicted and a baseline FEV1(maximum
             recorded value)/FVC(maximum recorded value)>70% predicted (using the Standardized Lung
             Function Testing guidelines produced by European Community for Coal and Steel)

          -  There are no conditions or factors which would make the subject unlikely to be able to
             stay in the chamber for 4 hours.

          -  The subject is capable of giving informed consent which includes compliance with the
             requirements and restrictions listed in the consent form

          -  The subject is available to complete all study measurements.

        Exclusion Criteria:

          -  Pregnant or nursing females

          -  Women of childbearing potential who are unwilling or unable to use an appropriate
             method of contraception, as listed in Section 8.1, from at least two weeks prior to
             the first dose of study medication; and to continue until the end of the study.

          -  On examination the subject is found to have any structural nasal abnormalities or
             nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent
             (within 3 weeks) or ongoing upper respiratory tract infection which in the Responsible
             Physician's opinion renders the subject unsuitable for participation in the study

          -  Any respiratory disease other than mild stable asthma that is controlled with
             occasional use of as-needed short-acting beta-agonists and associated with normal lung
             function.

          -  The subject is likely to be unable to abstain from salbutamol use for 8 hours before a
             challenge

          -  The subject has a history of drug or other allergy that, in the opinion of the
             physician responsible, contraindicates their participation.

          -  The subject is concurrently participating in another clinical study or has
             participated in a study with an investigational product (new chemical entity) during
             the previous 4 months or in any clinical study during the previous month.

          -  The subject has a screening QTc(B) value >450msec, PQ interval outside the range 120
             to 240msec or an ECG that is not suitable for QT measurements (e.g. poorly defined
             termination of the T-wave). In addition subjects will be excluded if they have a
             history of atrial and ventricular arrhythmia.

          -  A supine blood pressure that is persistently higher than 140/90 millimetres of mercury
             (mmHg) at screening.

          -  A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.

          -  The subject has donated a unit of blood (450mL) within the previous 3 months or
             intends to donate within 3 months of completing the study.

          -  The subject is currently taking regular (or a course of) medication whether prescribed
             or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal
             remedies (e.g. St. John's Wort). Paracetamol (£2g/day) and occasional as needed use of
             short-acting beta agonists is permitted.

          -  The subject has used prescription or non-prescription drugs, including vitamins,
             herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days
             if the drug is a potent enzyme inducer) or 5 half-lives (which ever is longer) prior
             to the first dose of study medication, unless in the opinion of the Investigator and
             Sponsor the medication will not interfere with the study procedures or compromise
             subject safety.

          -  The subject has used oral, injectable or dermal steroids within 5 weeks or intranasal
             and/or inhaled steroids within 1 week of the screening visit.

          -  Past or present disease, which as judged by the investigator, may affect the outcome
             of this study. These diseases include, but are not limited to, cardiovascular disease,
             malignancy, hepatic disease, renal disease*, haematological disease, neurological
             disease, endocrine disease or pulmonary disease (including but not confined to chronic
             bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).

             *subjects will require normal serum creatinine clearance values at screening
             [calculated from serum creatinine by a predicting equation using Cockcroft-Gualt
             formula]. If the creatinine clearance value is greater than the upper limit of normal
             as determined by the local laboratory reference range, the Investigator will determine
             whether this is a clinically significant finding that would preclude participation.

          -  The subject regularly drinks more than 28 units of alcohol in a week if male, or 21
             units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of
             wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.

          -  The subject is at risk of non-compliance with the study procedures/restrictions.

          -  The subject is infected with the Hepatitis B, Hepatitis C, or HIV virus.

          -  The subject has an elevated Troponin T above the normal range.

          -  The subject, as deemed by the Investigator has a clinically significant CK-MB value
             above the normal range.