Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
- Registration Number
- NCT00972140
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 457
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Formoterol-HFA Formoterol Formoterol-HFA pMDI 12µg twice daily Formoterol-DPI Formoterol Formoterol-DPI 12µg twice daily
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue Every 6 weeks
Trial Locations
- Locations (1)
Prof. Iwona Graelewska Rzymowska
🇵🇱Lodz, Lódz, Poland
Prof. Iwona Graelewska Rzymowska🇵🇱Lodz, Lódz, Poland