Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chiesi

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Formoterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972140

RA-PR-3301-011-04

Details and patient eligibility

About

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.

Full 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

Enrollment

457 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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