Dose Finding Study of CHF 4226 for Treating Patients With COPD

This study has been completed.
Sponsor:
Collaborator:
Chiesi Pharmaceuticals Inc.
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00605891
First received: January 18, 2008
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in FEV1 [ Time Frame: Day 1 to Day 14 (+3 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 [ Time Frame: 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) ] [ Designated as safety issue: No ]
  • ECG/QTc [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ] [ Designated as safety issue: Yes ]
  • Fasting serum potassium [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ] [ Designated as safety issue: Yes ]
  • Fasting glucose [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 278
Study Start Date: October 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
  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: NCT00605891

  Show 50 Study Locations
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Chiesi Pharmaceuticals Inc.
Investigators
Principal Investigator: Barry Make, MD National Jewish Medical & Research Center
Study Director: Steven E Linberg, Ph.D. Chiesi Pharmaceuticals Inc.
  More 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
Study First Received: January 18, 2008
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
South Africa: Medicines Control Council
Romania: National Medicines Agency

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

ClinicalTrials.gov processed this record on August 28, 2014