Clinical trial NCT00394199 (phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: fluticasone propionate/formoterol fumarate 100/10, fluticasone propionate 100, formoterol fumarate 10
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(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, [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(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, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1
Eligibility criteria:

        -  Ages eligible for study: 12 years and above

          -  Genders eligible for study: both

          -  Prior steroid use: steroid-requiring or steroid-free

        Inclusion Criteria:

          -  History of asthma for at least 12 months

          -  For steriod-requiring patients, documented use of inhaled corticosteroid for at least
             4 weeks prior to Screening Visit

          -  For steroid-free patients, no history of inhaled steroid asthma medication for at
             least 12 weeks prior to Screening Visit

          -  Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit

          -  Documented reversibility of 15% within 12 months of Screening or at Screening Visit
             (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized
             albuterol administration)

          -  Symptoms of asthma during Run-in

          -  Females of childbearing potential must have a negative urine pregnancy test at
             Screening and Baseline Visits. Females are eligible only if they are not pregnant or
             lactating, and are either sterile, or using acceptable methods of contraception.

          -  Must otherwise be healthy

          -  Provide written informed consent. Wishes of minors must be respected.

        Exclusion Criteria:

        Patients will not be eligible for the study if they meet any of the following criteria:

          -  Life-threatening asthma within the past year or during the Run-In Period.

          -  History of systemic corticosteroid medication within 3 months before the Screening
             Visit.

          -  History of omalizumab use within past 6 months.

          -  History of leukotriene receptor antagonist use, e.g., montelukast, within past week.

          -  Current evidence or history of any clinically significant disease or abnormality
             including uncontrolled hypertension, uncontrolled coronary artery disease, congestive
             heart failure, myocardial infarction, or cardiac dysrhythmia.

          -  Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during
             Run-In Period.

          -  Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary
             disease [COPD], cystic fibrosis, bronchiectasis).

          -  Known Human Immunodeficiency Virus (HIV)-positive status.

          -  Smoking history equivalent to "10 pack years".

          -  Current smoking history within 12 months prior to Screening Visit.

          -  Current evidence or history of alcohol and/or substance abuse within 12 months prior
             to Screening Visit.

          -  Patients who are confined in institution.