Clinical trial NCT00398645 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: gw685698x 200mcg,gw685698x 200mcg and 400mcg
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)C3=CC=CO3)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion criteria:

          -  Type of Subject: Outpatient

          -  Age: 12 years of age or older at Visit 1 (or ³18 years of age or older if local
             regulations or the regulatory status of study medication permit enrollment of adults
             only).

          -  Gender: Male or eligible female - Females are eligible to participate only if they are
             currently non-pregnant and non-lactating. To be eligible for entry into the study,
             females of childbearing potential must commit to consistent and correct use of an
             acceptable method of birth control, as defined by the following: Male partner who is
             sterile prior to the female subject's entry into the study and is the sole sexual
             partner for that female subject, Implants of levonorgestrel, Injectable progestogen,
             Oral contraceptive (either combined estrogen/progestin or progestin only), Any
             intrauterine device (IUD) with a documented failure rate of less than 1% per year,
             Double-barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a
             male condom or a spermicide and female diaphragm), The contraceptive transdermal
             patch, Ortho Evra (if the subject is less than 198 pounds), Female subjects should not
             be enrolled if they plan to become pregnant during the time of study participation. A
             urine pregnancy test is required for all subjects at all visits, Female subjects
             should not be enrolled if they plan to become pregnant during the time of study
             participation. A urine pregnancy test is required for all subjects at all visits,
             Female subjects should not be enrolled if they plan to become pregnant during the time
             of study participation. A urine pregnancy test is required for all subjects at all
             visits, Females of childbearing potential who are not sexually active must commit to
             complete abstinence from intercourse throughout the clinical trial, and for a period
             after the trial to account for elimination of the drug (minimum of six days),

          -  Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National
             Institutes of Health, 2002; GINA, 2005].

          -  Severity of Disease: A best AM FEV1 of 50% to 80% of the predicted value during Visit
             1 based on the "Standardization of Lung Function Tests" [European Respiratory Society,
             1993] standards for 18 years and older or Polgar [Polgar, 1971] standards for 12 to 17
             years and race adjusted for African-Americans [American Thoracic Society, 1991].

          -  Reversibility of Disease: Demonstrated ³12% and 200mL reversibility of FEV1 within 30
             minutes following 200 to 400mcg of albuterol/salbutamol inhalation aerosol (or one
             nebulized albuterol/salbutamol treatment) at Visit 1. If a subject fails to
             demonstrate an increase in FEV1 of ³12% and 200mL, the subject is not eligible for the
             study and will not be allowed to re-screen.

          -  Concurrent Anti-Asthma Therapy: Subjects must be using an inhaled corticosteroid for
             at least 3 months prior to Visit 1 and be maintained on a stable dose for four weeks
             prior to Visit 1 at one of the following doses: Anti-Asthma Therapy Maximum Daily Dose
             (mcg/day) Fluticasone propionate MDI CFC/HFA ≤220mcg1/≥250mcg2 Fluticasone propionate
             DPI 200mcg Beclomethasone dipropionate 420mcg1/500mcg2 Beclomethasone dipropionate HFA
             160mcg1/200mcg2 Budesonide DPI 400mcg Flunisolide 1000mcg Triamcinolone acetonide
             1000mcg Mometasone furoate 200mcg Ciclesonide 160mcg1/200mcg2

               1. Ex-actuator dose: dose delivered to the lungs

               2. Ex-valve dose: dose expressed from the valve

          -  Short-Acting Beta2-Agonist: All subjects must be able to replace short-acting
             beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use
             as-needed for the duration of the study. Subjects must be able to withhold all inhaled
             short-acting beta-sympathomimetic bronchodilators for at least 6 hours prior to study
             visits.Note: Nebulized albuterol/salbutamol will not be allowed during the study with
             the exception of its use during reversibility testing at Visit 1. The use of
             albuterol/salbutamol through the DISKUS/ACCUHALER device will not be allowed during
             the study.

          -  Informed Consent: All subjects must be able and willing to give written informed
             consent to take part in the study.

          -  Compliance: Subjects must be able to comply with all the study requirements.

        Exclusion criteria:

          -  History of Life-Threatening Asthma: History of life-threatening asthma, defined as an
             asthma episode that required intubation and/or was associated with hypercapnia,
             respiratory arrest or hypoxic seizures.

          -  Anti-Asthma Medications: Asthma medications listed below must not have been used prior
             to Visit 1 for the required interval listed below, and not taken during the study:
             Within 24 hours of Visit 1: Oral short-acting beta2-agonists: Within 2 weeks of Visit
             1:Combination therapy containing inhaled beta2-agonists and ICS for asthma (e.g.,
             fluticasone propionate/salmeterol combination, budesonide/formoterol
             combination);Slow-release bronchodilators (e.g., aminophylline,
             theophylline);Anticholinergics; Long-acting beta2-agonists (e.g., salmeterol);
             Ketotifen; Nedocromil sodium; Sodium cromoglycate; Oral long-acting beta2-agonists.
             Within 4 weeks of Visit 1: Anti-leukotrienes including suppressors of leukotriene
             production and antagonists. Within 12 weeks of Visit 1: Systemic, oral, parenteral, or
             depot corticosteroids; Anti-IgE (e.g., omalizumab).

          -  Other Medications: The medications listed below must not have been used prior to Visit
             1 for the required interval indicated below, and not taken during the study: Within 4
             weeks of Visit 1: Known potent inhibitors of CYP3A4 (e.g., ritonavir, ketoconazole)

          -  Respiratory Infection: History of a respiratory tract infection within 4 weeks of
             Visit 1. In addition, the subject must be excluded, if such infection occurs between
             Visits 1 and 2.

          -  Asthma Exacerbation: History of a an asthma exacerbation within 4 weeks of Visit 1,
             any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1, or
             any hospitalization due to asthma exacerbation within 6 months of Visit 1.

          -  Investigational Medications: A subject must not have used any investigational drug
             within 30 days prior to Visit 1 or within ten half-lives (t1/2) of the prior
             investigational study (which ever is longer of the two) or concurrently during the
             study.

          -  Concurrent Diseases/Abnormalities: Historical or current evidence of clinically
             significant uncontrolled disease including, but not limited to: cardiovascular
             disease, malignancy, hepatic disease, renal disease, hematological disease,
             neurological disease, or pulmonary disease (including, but not confined to chronic
             bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis,
             bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is
             defined as any disease that, in the opinion of the investigator, would put the safety
             of the subject at risk through participation, or which would affect the efficacy or
             safety analysis if the disease/condition exacerbated during the study.

          -  Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has
             evidence of oropharyngeal candidiasis at Visit 1.

          -  Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to
             any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic
             corticosteroid therapy.

          -  Milk Protein Allergy: History of severe milk protein allergy.

          -  Immunosuppressive Medications: A subject must not be using, or require use of,
             immunosuppressive medications during the study.

        Note: Immunotherapy for the treatment of allergies is allowed during the study provided
        that it was initiated prior to Visit 1 and the subject is maintained on a stable daily dose
        throughout the study period.

          -  Attendance: A subject will not be eligible if he/she or his/her parent or legal
             guardian has any infirmity, disability, or geographical location which seems likely
             (in the opinion of the Investigator) to impair compliance with any aspect of this
             study protocol or scheduled visits to the study center and compliance with study
             medication or procedures (e.g., completion of daily diary). Neurological or
             psychiatric disease or history of drug or alcohol abuse which would interfere with the
             subject's proper completion of the protocol requirements excludes study participation.

          -  Tobacco Use: A subject may not have used tobacco products within the past one year
             (i.e., cigarettes, cigars, or pipe tobacco) and must not have historical use of >10
             pack years (e.g., 20 cigarettes/day for 10 years).

          -  Affiliation with Investigator's Site: A subject will not be eligible for this study if
             he/she is an immediate family member of the participating investigator,
             sub-investigator, study coordinator, or employee of the participating investigator.