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

Information source: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Formoterol (Drug); Formoterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Chiesi Farmaceutici S.p.A.

Official(s) and/or principal investigator(s):
Iwona Graelewska Rzymowska, Prof, Principal Investigator, Affiliation: Clinic Pneumology and Allergology Lodz Poland

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatment

Secondary outcome: Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue

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

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Prof. Iwona Graelewska Rzymowska, Lodz, Lódz 91-520, Poland
Additional Information

Starting date: August 2005
Last updated: December 12, 2011

Page last updated: August 23, 2015

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