Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A 3-month, Double-blind, Double-dummy, Randomised, Multinational, Multicenter, 2-arm Parallel-group Study Comparing the Efficacy and Safety of Formoterol-HFA pMDI 12µg Twice Daily and Formoterol-DPI 12µg Twice Daily, in Patients With Stable Chronic Obstructive Pulmonary Disease
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.
Status | Completed |
Enrollment | 457 |
Est. completion date | October 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 ß2-agonists during the 14-week study period. - Short-acting ß2-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 ß2-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 ß2-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. - ß-blockers in the week preceding the screening visit and during the 14-week study period. - Intolerance to inhaled ß2-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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Prof. Iwona Graelewska Rzymowska | Lodz | Lódz |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue | Every 6 weeks | No |
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