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

NCT00782535 | Completed Phase 2

• 1 other identifier: CCD-0810-PR-0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• FEV1

  T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period

Secondary Outcomes (5)

• serum potassium

  pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period

• serum glucose

  pre dose and 1, 4, 6 and 24 hrs post dose for each treatment period

• plasma concentrations of CHF 4226

  pre dose and 15 minutes and 2 hours post dose for each treatment period

• urinary excretion of CHF 4226

  pre dose and 0-24 hrs post dose for each treatment period

• FVC

  T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period

Study Arms (5)

Treatment A

EXPERIMENTAL

Single therapeutic dose of CHF 4226 pMDI

Drug: CHF 4226 pMDI

Treatment B

EXPERIMENTAL

Single therapeutic dose of CHF 4226 pMDI

Drug: CHF 4226 pMDI

Treatment C

EXPERIMENTAL

Single supratherapeutic dose of CHF 4226 pMDI

Drug: CHF 4226 pMDI

Treatment D

EXPERIMENTAL

Single supratherapeutic dose of CHF 4226 pMDI

Drug: CHF 4226 pMDI

Treatment E

PLACEBO COMPARATOR

Single dose of placebo

Drug: Placebo

Interventions

CHF 4226 pMDI DRUG

Inhaled solution, single therapeutic dose

Treatment A; Treatment B

Placebo DRUG

Inhaled solution, single dose of placebo

Treatment E

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (5)

University Clinical Research DeLand, LLC

DeLand, Florida, 32720, United States

Location

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, 42431, United States

Location

New Horizons Clinical Research Center

Cincinnati, Ohio, 45242, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory M Gottschlich, MD

  New Horizons Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 6, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)