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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00972140
First received: September 3, 2009
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Formoterol
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

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 [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 457
Study Start Date: August 2005
Study Completion Date: October 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formoterol-HFA
Formoterol-HFA pMDI 12µg twice daily
Drug: Formoterol
Formoterol-HFA pMDI 12µg twice daily
Other Name: Atimos
Active Comparator: Formoterol-DPI
Formoterol-DPI 12µg twice daily
Drug: Formoterol
Formoterol-DPI 12 µg twice daily
Other Name: Foradil

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972140

Locations
Poland
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
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00972140     History of Changes
Other Study ID Numbers: RA-PR-3301-011-04
Study First Received: September 3, 2009
Last Updated: December 12, 2011
Health Authority: Bulgaria: Bulgarian Drug Agency
Poland: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Chiesi Farmaceutici S.p.A.:
Patients with stable COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014