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

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ClinicalTrials.gov Identifier: NCT00782535
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : November 21, 2011
Information provided by (Responsible Party):
Chiesi USA

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: CHF 4226 pMDI Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment A
Single therapeutic dose of CHF 4226 pMDI
Drug: CHF 4226 pMDI
Inhaled solution, single therapeutic dose
Experimental: Treatment B
Single therapeutic dose of CHF 4226 pMDI
Drug: CHF 4226 pMDI
Inhaled solution, single therapeutic dose
Experimental: Treatment C
Single supratherapeutic dose of CHF 4226 pMDI
Drug: CHF 4226 pMDI
Inhaled solution, single supratherapeutic dose
Experimental: Treatment D
Single supratherapeutic dose of CHF 4226 pMDI
Drug: CHF 4226 pMDI
Inhaled solution, single supratherapeutic dose
Placebo Comparator: Treatment E
Single dose of placebo
Drug: Placebo
Inhaled solution, single dose of placebo

Primary Outcome Measures :
  1. FEV1 [ Time Frame: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period ]

Secondary Outcome Measures :
  1. serum potassium [ Time Frame: pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period ]
  2. serum glucose [ Time Frame: pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period ]
  3. plasma concentrations of CHF 4226 [ Time Frame: pre dose and 15 minutes and 2 hours post dose for each treatment period ]
  4. urinary excretion of CHF 4226 [ Time Frame: pre dose and 0-24 hrs post dose for each treatment period ]
  5. FVC [ Time Frame: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 </= 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.

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

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 ClinicalTrials.gov identifier (NCT number): NCT00782535

United States, Florida
University Clinical Research DeLand, LLC
DeLand, Florida, United States, 32720
United States, Kentucky
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States, 42431
United States, Ohio
New Horizons Clinical Research Center
Cincinnati, Ohio, United States, 45242
United States, Oregon
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Chiesi USA
Principal Investigator: Gregory M Gottschlich, MD New Horizons Clinical Research

Responsible Party: Chiesi USA
ClinicalTrials.gov Identifier: NCT00782535     History of Changes
Other Study ID Numbers: CCD-0810-PR-0001
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases