Overview

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

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Chiesi Pharmaceuticals Inc.
Criteria
Inclusion Criteria:

- 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 retesting during the run-in period, at least 24 hours prior to Visit 2.

Exclusion Criteria:

- 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)

- Patient has a known intolerance/hypersensitivity to β2-adrenergic agonists, propellant
gases/excipients

- Patient is pregnant or lactating female, or female physiologically capable of becoming
pregnant UNLESS they meet the following definition of post-menopausal: 12 months of
natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH
levels > 40 mIU/mL OR are using one or more of the following acceptable methods of
contraception:

- surgical sterilization (e.g., bilateral tubal ligation, hysterectomy)

- hormonal contraception (implantable, patch, oral)

- double-barrier methods (any double combination of: IUD, male or female condom with
spermicidal gel, diaphragm, sponge, cervical cap)

- Patient is male and does not agree to use a medically acceptable contraceptive
(abstain from sexual intercourse, or use a condom with spermicide), or has not had a
vasectomy at least 6 months prior to study participation, unless their sexual partner
is not of child-bearing potential

- Patient is mentally or legally incapacitated

- Patient has participated in another investigational study within 30 days prior to
screening

- Patient abuses alcohol or other substances

- Patient does not maintain regular day/night, waking/sleeping cycles (e.g., night shift
worker)

- Patient is potentially non-compliant or unable to perform required outcome
measurements of the protocol