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

Phase 3
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
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
GroupInterventionDescription
Formoterol-HFAFormoterolFormoterol-HFA pMDI 12µg twice daily
Formoterol-DPIFormoterolFormoterol-DPI 12µg twice daily
Primary Outcome Measures
NameTimeMethod
12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatmentEvery 6 weeks
Secondary Outcome Measures
NameTimeMethod
Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescueEvery 6 weeks

Trial Locations

Locations (1)

Prof. Iwona Graelewska Rzymowska

🇵🇱

Lodz, Lódz, Poland

Prof. Iwona Graelewska Rzymowska
🇵🇱Lodz, Lódz, Poland

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