Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Formoterol-HFA Formoterol-HFA pMDI 12µg twice daily |
Drug: Formoterol
Formoterol-HFA pMDI 12µg twice daily
Other Names:
|
| Active Comparator: Formoterol-DPI Formoterol-DPI 12µg twice daily |
Drug: Formoterol
Formoterol-DPI 12 µg twice daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue [Every 6 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female patients who gave written informed consent.
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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
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Age 40 years or older. Male and female patients who gave written informed consent
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History of a progressive nature of symptoms and a complaint of dyspnoea at least on exertion.
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Current or previous smoker [in both cases with a cumulative exposure to cigarette smoke of more than 20 pack-years
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Pre-bronchodilator baseline 40% > FEV1 < 70% of the predicted normal value
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Absolute value FEV1 > 0.9 L.
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FEV1/FVC < 70% (ERS criteria for predicted normal value).
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FEV1 reversibility test 30 minutes following inhalation of 400 μg of salbutamol pMDI
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A cooperative attitude and ability to be trained to use correctly the pMDI and the Aerolizer® inhaler
Exclusion Criteria:
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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).
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Current or past diagnosis of asthma.
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History of allergic rhinitis or other atopic disease (e.g. eczema).
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Largely reversible airflow obstruction.
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Onset of obstructive symptoms early in life (i.e. childhood).
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Variability of symptoms from day to day and frequent symptoms at night and early morning.
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A total blood eosinophil count higher than 500/μL.
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Significant and unstable concomitant cardiovascular, renal, hepatic, gastrointestinal,neurological, endocrine, metabolic, musculo-skeletal, neoplastic, respiratory or other clinically significant disease
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Clinical significant laboratory abnormalities indicating a significant or unstable concomitant disease.
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QTc interval (Bazett formula) higher than 460 msec
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Total 24 hours respiratory symptom score (day-time and night-time) > 2 on at least 4 consecutive days
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Lower respiratory tract infection within one month before screening visit
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Hospitalisation or emergency room treatment for an acute COPD exacerbation in the month before screening visit
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Long-term oxygen therapy.
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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.
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Patients treated with depot corticosteroids in the three months preceding the screening visit and during the 14-week study period.
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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
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Patients treated with inhaled long-acting β2-agonists during the 14-week study period.
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Short-acting β2-agonists on regular use during the 14-week study period 8 hours preceding the screening visit
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Short-acting anticholinergic medications during the 14-week study period
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Long-acting anticholinergic medications (e.g. tiotropium) during the 14-week study period.
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Inhaled fixed combinations of a short-acting β2-agonist and a short-acting anticholinergic medication (e.g. Combivent) during the 14-week study period
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Inhaled fixed combinations of an inhaled corticosteroid and a long-acting β2-agonist (e.g.Seretide, Symbicort) during the 14-week study period.
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Long-acting antihistamines (e.g. Astemizole, Terfenadine) in the three months preceding the screening visit and during the 14-week study period.
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Tricyclic antidepressants, monoamine oxidase inhibitors (MAOI) and other drugs known to prolong the QTc interval during the 14-week study period.
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β-blockers in the week preceding the screening visit and during the 14-week study period.
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Intolerance to inhaled β2-adrenergic agents.
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History of intolerance or allergic reactions to any of the pMDI and DPI excipients.
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Patients who had evidence of alcohol or substance abuse, not compliant with the study protocol or not compliant with the study treatments.
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Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prof. Iwona Graelewska Rzymowska | Lodz | Lódz | Poland | 91-520 |
Sponsors and Collaborators
- Chiesi Farmaceutici S.p.A.
Investigators
- Principal Investigator: Iwona Graelewska Rzymowska, Prof, Clinic Pneumology and Allergology Lodz Poland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RA-PR-3301-011-04