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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014