Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Patients with stable COPD
Brief 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.
Detailed description
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
Interventions
DRUGFormoterol
Formoterol-HFA pMDI 12µg twice daily
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatment | Every 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue | Every 6 weeks |
Countries
Poland
Outcome results
None listed