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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972140
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : December 13, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Formoterol Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue [ Time Frame: Every 6 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00972140

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Prof. Iwona Graelewska Rzymowska
Lodz, Lódz, Poland, 91-520
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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Principal Investigator: Iwona Graelewska Rzymowska, Prof Clinic Pneumology and Allergology Lodz Poland
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Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT00972140    
Other Study ID Numbers: RA-PR-3301-011-04
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011
Keywords provided by Chiesi Farmaceutici S.p.A.:
Patients with stable COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action