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

This study has been completed.
Sponsor:
Collaborator:
Chiesi Pharmaceuticals Inc.
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00640484
First received: March 18, 2008
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: carmoterol (CHF 4226)
Drug: placebo
Drug: salmeterol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of 2 Weeks Treatment With CHF 4226 pMDI 2µg and 4µg, Given Once Daily in the Morning, on 24-Hour FEV1 in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • FEV1 AUC0-24 standardized by time [ Time Frame: on Day 15 (after 14 days of dosing) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1(L) [ Time Frame: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: at the beginning and end of each of the four 14-day treatment periods ] [ Designated as safety issue: Yes ]
  • heart rate [ Time Frame: at the beginning and end of each of the four 14-day treatment periods ] [ Designated as safety issue: Yes ]
  • FEV1 percent change [ Time Frame: 30 min, 1, 2 ,3, 4, 6, 10, 12, 14, 16, 22, 23, and 24 hrs post dose at Visit 2 at all treatment periods ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
CHF 4226 (carmoterol) 2 μg once a day, in the morning
Drug: carmoterol (CHF 4226)

carmoterol (CHF 4226) 2 μg once a day, in the morning

(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI)

Other Names:
  • CHF 4226
  • TA2005
Experimental: B
CHF 4226 (carmoterol) 4 μg once a day, in the morning
Drug: carmoterol (CHF 4226)

carmoterol (CHF 4226) 4 μg once a day, in the morning

(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg)

Other Names:
  • CHF 4226
  • TA2005
Placebo Comparator: C
placebo once a day, in the morning
Drug: placebo

placebo once a day, in the morning

(1 puff of placebo pMDI + 1 puff of placebo pMDI)

Active Comparator: D
salmeterol 50 μg twice daily, in the morning and in the evening
Drug: salmeterol

Salmeterol 50 μg twice daily, in the morning and in the evening

(1 blister of Serevent Diskus BID)

Other Name: Serevent Diskus/Accuhaler

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Patient is pregnant or lactating female, or female at risk of pregnancy (i.e., not using adequate contraceptive method: surgical sterilization [e.g., bilateral tubal ligation], hormonal contraception [implantable, patch, oral], IUD, and double-barrier methods [any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap]).
  • Patient is mentally or legally incapacitated
  • Patient has participated in another investigational study within 30 days prior to screening
  • Abuse of 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 protocol outcome measurements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640484

Locations
United States, Arizona
Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, United States, 85295
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
United States, California
UCLA David Geffen School of Medicine
Los Angeles, California, United States, 90095
United States, Florida
University Clinical Research - DeLand, LLC
DeLand, Florida, United States, 32720
United States, Georgia
Pulmonary Medicine and Critical Care
Austell, Georgia, United States, 30106
United States, Illinois
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States, 61761
United States, Kentucky
Commonwealth BioMedical Research
Madisonville, Kentucky, United States, 42431
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Ohio
New Horizons Clinical Research
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
Asthma Allergy Associates
Portland, Oregon, United States, 97213
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Reichman Associates
Sugar Land, Texas, United States, 77074
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Chiesi Pharmaceuticals Inc.
Investigators
Principal Investigator: Donald P. Tashkin, MD University of California, Los Angeles
Study Director: Steven E. Linberg, PhD Chiesi Pharmaceuticals Inc.
  More Information

Publications:

Responsible Party: Steven E. Linberg, PhD, Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00640484     History of Changes
Other Study ID Numbers: CCD-0706-PR-0026
Study First Received: March 18, 2008
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014