- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972140
Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
December 12, 2011 updated by: Chiesi Farmaceutici S.p.A.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
457
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lódz
-
Lodz, Lódz, Poland, 91-520
- Prof. Iwona Graelewska Rzymowska
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Formoterol-HFA
Formoterol-HFA pMDI 12µg twice daily
|
Formoterol-HFA pMDI 12µg twice daily
Other Names:
Formoterol-DPI 12 µg twice daily
Other Names:
|
Active Comparator: Formoterol-DPI
Formoterol-DPI 12µg twice daily
|
Formoterol-HFA pMDI 12µg twice daily
Other Names:
Formoterol-DPI 12 µg twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Every 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pulmonary Function tests :FEV1, FVC, symptom scores, COPD exacerbations, used of rescue
Time Frame: Every 6 weeks
|
Every 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Iwona Graelewska Rzymowska, Prof, Clinic Pneumology and Allergology Lodz Poland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
April 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
September 3, 2009
First Submitted That Met QC Criteria
September 3, 2009
First Posted (Estimate)
September 4, 2009
Study Record Updates
Last Update Posted (Estimate)
December 13, 2011
Last Update Submitted That Met QC Criteria
December 12, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- RA-PR-3301-011-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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