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Dose Finding Study of CHF 4226 for Treating Patients With COPD

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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.

January 18, 2008
January 31, 2008
April 11, 2017
October 2006
June 2007   (Final data collection date for primary outcome measure)
Change in FEV1 [ Time Frame: Day 1 to Day 14 (+3 days) ]
Change in FEV1 [ Time Frame: Day 1 and Day 14 (+3 days) ]
Complete list of historical versions of study NCT00605891 on ClinicalTrials.gov Archive Site
  • FEV1 [ Time Frame: 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) ]
  • ECG/QTc [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
  • Fasting serum potassium [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
  • Fasting glucose [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
  • 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) ]
  • Pulmonary Function Tests [ Time Frame: 10 and 30 min, 1, 2, and 3 hrs post dose on Day 1, Day 2 and Day 14 (+3) ]
  • ECG/QTc [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
  • Fasting serum potassium and glucose [ Time Frame: pre dose and post dose at 30' on Days 1, 2 and 14 (+3) ]
Not Provided
Not Provided
 
Dose Finding Study of CHF 4226 for Treating Patients With COPD
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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
  • 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
  • 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
  • Drug: salmeterol
    Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
    Other Name: Serevent® Diskus®/Accuhaler®
  • Drug: placebo
    Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)
  • Experimental: A
    carmoterol (CHF 4226) 1.0 μg once a day, in the morning
    Intervention: Drug: carmoterol (CHF 4226)
  • Experimental: B
    carmoterol (CHF 4226) 2.0 μg once a day, in the morning
    Intervention: Drug: carmoterol (CHF 4226)
  • Experimental: C
    carmoterol (CHF 4226) 4.0 μg once a day, in the morning
    Intervention: Drug: carmoterol (CHF 4226)
  • Placebo Comparator: D
    Placebo once a day, in the morning
    Intervention: Drug: placebo
  • Active Comparator: E
    Salmeterol 50 μg BID, in the morning and in the evening
    Intervention: Drug: salmeterol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
Same as current
June 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Poland,   Romania,   South Africa,   United States
 
 
NCT00605891
US/PR/033009/001/05
EudraCT Number: 2006-000531-10
No
Not Provided
Not Provided
Steven Linberg/ Managing Director, Chiesi Pharmaceuticals Inc.
Chiesi Farmaceutici S.p.A.
Chiesi USA
Principal Investigator: Barry Make, MD National Jewish Medical & Research Center
Study Director: Steven E Linberg, Ph.D. Chiesi USA
Chiesi Farmaceutici S.p.A.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP