Safety and Efficacy Study of Treatment With Single Doses of CHF 4226 pMDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to characterize the dose-response profile of peak and trough FEV1 after single dose administrations of carmoterol in patients with COPD.

Key facts

Study ID

NCT00782535

Run by

Chiesi Farmaceutici S.p.A.

People needed

20

Starts

2008-12-01

Expected to finish

2009-03-01

Last updated by the study team

2019-11-06

Who can join

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

You may qualify if…

• Patient has signed an IRB approved Informed Consent form and the written informed consent was obtained prior to any study-related procedure(s)
• Patient is a male or non-pregnant female, 40 -75 years old, inclusive
• Patient has a current or past cigarette smoking history of at least 15 pack-years
• Patient has a clinical diagnosis of COPD in accordance with the recommendations of the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
• Patient meets the following requirements after an FEV1 albuterol reversibility test (i.e., 30 minutes following 400µg (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, then this requirement must be met after retesting during the run-in period, at least 24 hours prior to Visit 2.

You may not qualify if…

• Patient has a history of asthma
• Patient has a blood eosinophil count > 500/µL
• Patient has a history of allergic rhinitis or atopy
• Patient had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids
• Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period
• Patient has an 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 the judgment of the Investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
• Patient has clinically significant abnormal routine hematology (e.g., anemia) and/or clinical chemistry value(s).
• Patient has a history of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
• Patient has lung cancer or a history of lung cancer
• Patient has active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
• Patient has a serum potassium value ≤ 3.5 mEq/L or > 5.5mEq/L and/or a fasting serum glucose value ≥ 140 mg/dL
• Patient has an abnormal QTcF interval value in the Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females)
• Patient has developed Cor Pulmonale
• Patient is receiving long term oxygen therapy, i.e., > 16 hours/24-hour period, every day, unless residing at an elevation > 4000ft
• Patient has used any of the following medications prior to Screening and has not met the 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: 6 hours
• Theophylline and other xanthines: 1 week
• Parenteral or oral corticosteroids: 1 month
• Patient has taken any non-permitted medication
• Patient has received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in (inactivated Influenza vaccination is acceptable provided it is not administered within 48 hours prior to Screening)

Where it is running

• University Clinical Research DeLand, LLC — DeLand, Florida, United States
• Commonwealth Biomedical Research, LLC — Madisonville, Kentucky, United States
• New Horizons Clinical Research Center — Cincinnati, Ohio, United States
• Clinical Research Institute of Southern Oregon, PC — Medford, Oregon, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States

Full record on ClinicalTrials.gov

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