Clinical trial NCT00497237 (phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: beclomethasone plus formoterol fixed combination, fluticasone plus salmeterol fixed combination
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=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
Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be enrolled for screening at Visit 1 into the run-in period if they meet
             all the following criteria:

          -  Clinical diagnosis of moderate persistent asthma for at least 6 months, according to
             GINA revised version 2005 guidelines 1 and considering current treatment;

          -  Forced expiratory volume (FEV1) or peak expiratory flow rate (PEFR) ≥ 80% of the
             predicted normal value;

          -  Treated with fluticasone 1000 mcg + salmeterol 100 mcg daily for at least 4 weeks at a
             stable dose;

          -  Reporting no nocturnal symptoms or awakenings, no exacerbations, no limitations of
             activities, symptoms in ≤2 days and use of rescue medication ≤2 days per week, in the
             last 4 weeks;

          -  Exhibiting a co-operative attitude and ability to be trained to correctly use the
             study devices and to complete the diary cards.

        At the end of run in period (Week 8+0; Visit 3), patients will be recruited into the
        treatment period and randomized to treatment if they meet the following criterion:

          -  Asthma is controlled 1 in each of the last 4 weeks of run-in (no nocturnal symptoms or
             awakenings; no exacerbations; no limitations of activities; symptoms in ≤2 days; use
             of rescue medication ≤2 days; morning PEF ≥80% of predicted in every day) confirmed by
             reviewing the diary cards.

        Exclusion Criteria:

          -  Inability to carry out pulmonary function testing;

          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the
             NHLBI/WHO's GOLD guidelines;

          -  Current smokers or recent (less than one year) ex-smokers with a smoking history of
             ≥10 pack/years;

          -  History of near fatal asthma;

          -  Evidence of symptomatic infection of the airways in the previous 8 weeks;

          -  Three or more courses of oral corticosteroids or hospitalisation due to asthma during
             the previous 6 months;

          -  Patients treated with anticholinergics and antihistamines during the previous 2 weeks,
             with topical or intranasal corticosteroids and leukotriene antagonists during the
             previous 4 weeks;

          -  History or current evidence of heart failure, coronary artery disease, myocardial
             infarction, severe hypertension, cardiac arrhythmias;

          -  Diabetes mellitus;

          -  PTCA or CABG during the previous six months;

          -  Patients with an abnormal QTc interval value in the ECG test, defined as >450 msec in
             males or > 470 msec in females;

          -  Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial
             fibrillation with ventricular response, bradycardia (≤55 bpm), evidence of
             atrial-ventricular (AV) block on ECG of more than 1st degree;

          -  Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism,
             significant hepatic impairment, poorly controlled pulmonary (tuberculosis, active
             mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer),
             neurological or haematological autoimmune diseases;

          -  Cancer or any chronic diseases with prognosis <2 years;

          -  History of alcohol or drug abuse;

          -  Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or
             beta-blockers as regular use;

          -  Allergy, sensitivity or intolerance to study drugs and/or study drug formulation
             ingredients;

          -  Patients who received any investigational new drug within the last 12 weeks;

        At the end of run in period (Week 8+0; Visit 3), patients will not be randomized to
        treatment if they do not completely meet the definition of "controlled asthma". These
        subjects will be considered screening failures and will not count against the planned
        number to be recruited.