Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.

Key facts

Study ID

NCT00640484

Run by

Chiesi Farmaceutici S.p.A.

People needed

57

Starts

2008-04-01

Expected to finish

2008-10-01

Last updated by the study team

2010-08-27

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed IRB approved Informed Consent form
• Male or non-pregnant female, 40 -75 years old, inclusive
• Current or past cigarette smoking history of at least 15 pack-years
• Clinical diagnosis of COPD in accordance with recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
• Patient meets following requirements after FEV1 albuterol reversibility test (i.e., 30 minutes after 200μg (metered dose) albuterol MDI):
• FEV1/FVC < 70%
• FEV1 is at least 0.9L
• FEV1 30% - 80%, inclusive, of patient's predicted normal value; ∆FEV1 > 5% of pre-albuterol value
• If ∆FEV1 < 5% of pre-albuterol value, requirement must be met after retesting during run-in period, at least 24 hours prior to Period 1/Visit 1.

You may not qualify if…

• History of asthma
• Blood eosinophil count > 500/microliters
• History of allergic rhinitis or atopy
• COPD exacerbation or lower respiratory tract infection within 8 weeks prior to screening, or during run-in period, that resulted in use of an antibiotic, or oral or parenteral corticosteroids
• Inhaled corticosteroid that has been initiated, or effective dose has been changed, within 4 weeks prior to screening or during run-in period
• Uncontrolled cardiovascular (e.g., uncontrolled hypertension), respiratory, hematologic, immunologic, renal, neurologic, hepatic, endocrine (e.g., uncontrolled diabetes mellitus) or other disease, or any condition that might, in Investigator's judgment, place patient at undue risk or potentially compromise study results or interpretation
• History of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
• Lung cancer or history of lung cancer
• Active cancer or history of cancer with < 5 years disease free survival time (with or without evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of skin is acceptable.
• Serum potassium value ≤ 3.5 mEq/L or > 5.5mEq/L and/or fasting serum glucose value ≥ 140 mg/dL
• Abnormal QTcF interval value in Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females)
• Cor Pulmonale
• Long term oxygen therapy, i.e., > 16 hours/24-hour period, every day, unless patient resides at elevation > 4000ft
• Use of any of the following medications prior to Screening, without meeting specified minimum washout period:
• Long acting anti-cholinergic agent (i.e., tiotropium): 7 days
• Short acting anti-cholinergics: 8 hours
• Fixed combinations of β2-agonists and inhaled corticosteroids: 48 hours
• Fixed combinations of an anti-cholinergic and short acting β2-agonist: 8 hours
• Long-acting β2-agonists: 48 hours
• Short acting β2-agonists (other than those prescribed in the study): 6 hours
• Theophylline and other xanthines: 1 week
• Parenteral or oral corticosteroids: 1 month
• Patient has taken any non-permitted medication
• Patient has received live-attenuated virus vaccination within two weeks prior to screening or during run-in (inactivated Influenza vaccination is acceptable if given > 48 hours prior to Screening)
• Known intolerance/hypersensitivity to β2-adrenergic agonists, propellant gases/excipients

Where it is running

• Horizon Clinical Research Associates, PLLC — Gilbert, Arizona, United States
• Pulmonary Associates, PA — Phoenix, Arizona, United States
• UCLA David Geffen School of Medicine — Los Angeles, California, United States
• University Clinical Research - DeLand, LLC — DeLand, Florida, United States
• Pulmonary Medicine and Critical Care — Austell, Georgia, United States
• Sneeze, Wheeze & Itch Associates, LLC — Normal, Illinois, United States
• Commonwealth BioMedical Research — Madisonville, Kentucky, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• New Horizons Clinical Research — Cincinnati, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Clinical Research Institute of Southern Oregon, PC — Medford, Oregon, United States
• Asthma Allergy Associates — Portland, Oregon, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Reichman Associates — Sugar Land, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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