formoterol-hfa 3-month study in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to demonstrate the clinical equivalence of formoterol-hfa pmdi 12µg/actuation administered twice daily to formoterol dpi 12µg/capsule delivered by the aerolizer inhaler and administered twice daily in patients with copd.

phase iii, multicenter, multinational, double-blind, double-dummy, randomised, 2-arm parallel-group, 3-month study in patients with stable copd. comparison in terms of efficacy and safety of the two formulations of formoterol administered as 24µg/day in a bid regimen

Eligibility criteria:
inclusion criteria: * male and female patients who gave written informed consent. * diagnosis of stable copd according to the recommendations of the -diagnosis of stable copd according to the recommendations of the national heart lung and blood institute (nhlbi) global initiative for chronic obstructive lung disease (gold) criteria, edition 2003 * age 40 years or older. male and female patients who gave written informed consent * history of a progressive nature of symptoms and a complaint of dyspnoea at least on exertion. * current or previous smoker \[in both cases with a cumulative exposure to cigarette smoke of more than 20 pack-years * pre-bronchodilator baseline 40% \> fev1 \< 70% of the predicted normal value * absolute value fev1 \> 0.9 l. * fev1/fvc \< 70% (ers criteria for predicted normal value). * fev1 reversibility test 30 minutes following inhalation of 400 μg of salbutamol pmdi * a cooperative attitude and ability to be trained to use correctly the pmdi and the aerolizer® inhaler exclusion criteria: * female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with childbearing potential (e.g. contraceptive methods other than oral contraceptives, iud, tubal ligature). * current or past diagnosis of asthma. * history of allergic rhinitis or other atopic disease (e.g. eczema). * largely reversible airflow obstruction. * onset of obstructive symptoms early in life (i.e. childhood). * variability of symptoms from day to day and frequent symptoms at night and early morning. * a total blood eosinophil count higher than 500/μl. * significant and unstable concomitant cardiovascular, renal, hepatic, gastrointestinal,neurological, endocrine, metabolic, musculo-skeletal, neoplastic, respiratory or other clinically significant disease * clinical significant laboratory abnormalities indicating a significant or unstable concomitant disease. * qtc interval (bazett formula) higher than 460 msec * total 24 hours respiratory symptom score (day-time and night-time) \> 2 on at least 4 consecutive days * lower respiratory tract infection within one month before screening visit * hospitalisation or emergency room treatment for an acute copd exacerbation in the month before screening visit * long-term oxygen therapy. * patients treated with oral or injectable corticosteroids and antibiotics for a copd exacerbation and/or a lower respiratory tract infection in the month preceding the screening visit and during the run-in period of the study. * patients treated with depot corticosteroids in the three months preceding the screening visit and during the 14-week study period. * changes in dose, schedule, formulation or product of an inhaled or nasal corticosteroid and oral modified-release theophylline within one month of screening visit and during the 14 week study period * patients treated with inhaled long-acting β2-agonists during the 14-week study period. * short-acting β2-agonists on regular use during the 14-week study period 8 hours preceding the screening visit * short-acting anticholinergic medications during the 14-week study period * long-acting anticholinergic medications (e.g. tiotropium) during the 14-week study period. * inhaled fixed combinations of a short-acting β2-agonist and a short-acting anticholinergic medication (e.g. combivent) during the 14-week study period * inhaled fixed combinations of an inhaled corticosteroid and a long-acting β2-agonist (e.g.seretide, symbicort) during the 14-week study period. * long-acting antihistamines (e.g. astemizole, terfenadine) in the three months preceding the screening visit and during the 14-week study period. * tricyclic antidepressants, monoamine oxidase inhibitors (maoi) and other drugs known to prolong the qtc interval during the 14-week study period. * β-blockers in the week preceding the screening visit and during the 14-week study period. * intolerance to inhaled β2-adrenergic agents. * history of intolerance or allergic reactions to any of the pmdi and dpi excipients. * patients who had evidence of alcohol or substance abuse, not compliant with the study protocol or not compliant with the study treatments. * participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit

Keywords: patients with stable copd