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Dose Finding Study of CHF 4226 for Treating Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00605891
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Chiesi USA
Information provided by:
Chiesi Farmaceutici S.p.A.

Brief Summary:
The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be further developed for the treatment of patients with COPD.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled,14-Treatment Day, Multicenter Study to Determine the Optimal Efficacious and Safe Dose of CHF 4226 in a Metered Dose Inhaler in Treating Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : October 2006
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Salmeterol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
carmoterol (CHF 4226) 1.0 μg once a day, in the morning
Drug: carmoterol (CHF 4226)

carmoterol pMDI 1.0 μg once a day, in the morning

(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))

Other Name: CHF 4226
Experimental: B
carmoterol (CHF 4226) 2.0 μg once a day, in the morning
Drug: carmoterol (CHF 4226)

carmoterol pMDI 2.0 μg once a day, in the morning

(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)

Other Name: CHF 4226
Experimental: C
carmoterol (CHF 4226) 4.0 μg once a day, in the morning
Drug: carmoterol (CHF 4226)

carmoterol pMDI 4.0 μg once a day, in the morning

(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)

Other Name: CHF 4226
Placebo Comparator: D
Placebo once a day, in the morning
Drug: placebo
Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
Active Comparator: E
Salmeterol 50 μg BID, in the morning and in the evening
Drug: salmeterol
Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
Other Name: Serevent® Diskus®/Accuhaler®



Primary Outcome Measures :
  1. Change in FEV1 [ Time Frame: Day 1 to Day 14 (+3 days) ]

Secondary Outcome Measures :
  1. FEV1 [ Time Frame: 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) ]
  2. ECG/QTc [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
  3. Fasting serum potassium [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
  4. Fasting glucose [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
  5. Change in FEV1 [ Time Frame: 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) ]


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

Inclusion Criteria:

  • Patient has signed an IRB-/Ethics Committee-approved Informed Consent form
  • Patient is a male or non-pregnant female between the ages of 40 - 75 years, inclusive
  • Patient has a current or past 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 200 mcg (metered dose) albuterol/salbutamol pMDI):
  • FEV1 is at least 0.9L
  • FEV1 of 40% - 70%, inclusive, of patient's predicted normal value
  • Change in FEV1 > 4% of patient's predicted normal value

    • If change in FEV1 < 4% of patient's predicted normal value, then this requirement must be met after retesting during the run-in period, at least 24 hours prior to Day -1
  • FEV1/FVC < 70%

Exclusion Criteria:

  • Patient has a history of asthma, allergic rhinitis, or atopy
  • Patient has a blood eosinophil count > 500/microliter
  • 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 a history of coronary artery disease, cerebrovascular disease, cardiac arrhythmias
  • Patient has a concomitant disease of poor prognosis (e.g., cancer)
  • 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 QTc Fridericia 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
  • Patient has a known intolerance/hypersensitivity to Beta2-adrenergic agonists, propellant gases/excipients
  • Patient is receiving treatment with a tricyclic antidepressant or a monoamine oxidase inhibitor (MAOI)
  • Patient has received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in
  • Patient is pregnant or lactating female, or female at risk of pregnancy (i.e., not using an adequate contraceptive method)
  • 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 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): NCT00605891


  Hide Study Locations
Locations
United States, Arkansas
Clopton Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
ABM Research Center
Fresno, California, United States, 93720
UCSD - Clinical Trials Center
San Diego, California, United States, 92103
Institute of Healthcare Assessment Inc.
San Diego, California, United States, 92120
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
University Clinical Research - DeLand, LLC
DeLand, Florida, United States, 32720
Clinical Research of West Florida, Inc.
Tampa, Florida, United States, 33603
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Illinois
Edward Hospital and Helath Services, Center for Clinical Trials
Naperville, Illinois, United States, 60540
United States, Indiana
Community Clinical Research Center
Anderson, Indiana, United States, 46011
United States, Michigan
ClinSite, LLC
Ann Arbor, Michigan, United States, 48106
ClinSite
Canton, Michigan, United States, 48187
United States, New Jersey
Delaware Valley Clinical Research
Cherry Hill, New Jersey, United States, 08003
United States, North Carolina
Carolina Pharmaceutical Research
Statesville, North Carolina, United States, 28625
United States, Ohio
New Horizons Clinical Research
Cincinnati, Ohio, United States, 45242
Toledo Center for Clinical Research
Sylvania, Ohio, United States, 43560
United States, Oregon
Clinical Research Institute of Southern Oregon PC
Medford, Oregon, United States, 97504
Pulmonary Consultants - Research Department
Medford, Oregon, United States, 97504
United States, South Carolina
Lowcountry Lung and Critical Care, PA
North Charleston, South Carolina, United States, 29406
United States, Texas
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States, 79124
Breath of Life Research Institute
Katy, Texas, United States, 77450
The University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708
United States, Wisconsin
University of Wisconsin-Allergy/Asthma
Madison, Wisconsin, United States, 53792
Czech Republic
Ordinace pro nemoci dychaciho ustroji
Beroun, Czech Republic, 266 01
OTRAN
Kutna Hora, Czech Republic, 284 01
Plicni a alergologicka ambulance
Kutna Hora, Czech Republic, 284 01
Pneumolog, internista
Lovosice, Czech Republic, 310 02
Plicni ambulance
Praha 3 - Zizkov, Czech Republic, 130 00
Nemocnice Na Homolce Plicni ambulance
Praha 5, Czech Republic, 15030
Plicni ambulance Rokycany
Rokycany, Czech Republic, 337 01
Germany
Medars GmbH
Berlin, Germany, 14057
Lungenzentrum Geesthacht
Geesthacht, Germany, 21502
Pneumologisches Forschungsinstitut GmbH
Grosshansdorf, Germany, 22927
Pneumologisches Forschungsinstitut Niederlassung Hamburg
Hamburg, Germany, 20535
Robert-Koch-Klinik
Leipzig, Germany, 04207
SMO, MD GmbH
Magdeburg, Germany, 39112
IFG GmbH
Ruedersdorf, Germany, 15565
Poland
Medcare Specjalistyczna Opieka Medyczna NZOZ
Gdansk, Poland, 80-433
NZOZ Non-nocere
Gdansk, Poland, 80-847
Klinika Pulmonologii i Alergologii
Lodz, Poland, 90-153
SPZOZ w Proszowicach Oddzial Chorob Pluc
Proszowice, Poland, 32-100
Romania
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, Romania, 500326
Spitalul de Urgenta "Prof. Dr. Dimitrie Gerota"
Bucharest, Romania, 010457
Spitalul Clinic de Urgenta Militar Central "Davila"
Bucharest, Romania, 010825
Spitalul Clinic "Sf. Maria"
Bucharest, Romania, 011172
Institutul National de Pneumoftisiologie "M. Nasta"
Bucharest, Romania, 050159
Spitalul de Pneumoftiziologie Constanta
Constanta, Romania, 900002
South Africa
UCT Lung Institute
Mowbray, Cape Town, South Africa, 7700
Tiervlei Trial Center, Karl Bremer Hospital
Bellville, South Africa, 7530
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Chiesi USA
Investigators
Principal Investigator: Barry Make, MD National Jewish Medical & Research Center
Study Director: Steven E Linberg, Ph.D. Chiesi USA

Additional Information:
Publications:

Responsible Party: Steven Linberg/ Managing Director, Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00605891     History of Changes
Other Study ID Numbers: US/PR/033009/001/05
EudraCT Number: 2006-000531-10
First Posted: January 31, 2008    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

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