A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease

NCT03084796 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CCD-05993AA3-02
• Study Type: interventional
• Target: 733
• Locations: 1 country
• Sites: 112

Brief Summary

The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.

Conditions

COPD; Chronic Obstructive Pulmonary Disease

Keywords

CHF 5259; Chronic Obstructive Pulmonary Disease (COPD); pMDI (pressurized metered dose inhaler); GLIMMER

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in FEV1 AUC(0-12h) Normalized by Time at Week 6

  Change from baseline in FEV1 AUC(0-12h), normalized by time, at the end of treatment (Week 6). Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours). Definitions: AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-12h)=Mean FEV1 after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;

  Baseline, Week 6

Secondary Outcomes (23)

• Change From Baseline in FEV1 AUC(0-12h) Normalized by Time on Day 1

  Baseline, Day 1

• Change From Baseline in FEV1 AUC(0-4h) Normalized by Time on Day 1 and at Week 6

  Baseline, Day 1, Week 6

• Change From Baseline in FEV1 Peak(0-4h) at Day 1 and Week 6

  Baseline, Day 1, Week 6

• Change From Baseline in FVC AUC(0-12h), Normalized by Time on Day 1 and at Week 6

  Baseline, Day 1, Week 6

• Change From Baseline in FVC AUC(0-4h) Normalized by Time on Day 1 and at Week 6

  Baseline, Day 1, Week 6

Study Arms (6)

Treatment A

EXPERIMENTAL

CHF 5259 pMDI 6.25 μg, 1 inhalation twice daily (bid); (total daily dose \[TDD\] of CHF 5259 12.5 μg)

Drug: CHF 5259

Treatment B

EXPERIMENTAL

CHF 5259 pMDI 12.5 μg, 1 inhalation bid; (TDD of CHF 5259: 25 μg)

Drug: CHF 5259

Treatment C

EXPERIMENTAL

CHF 5259 pMDI 12.5 μg, 2 inhalations bid; (TDD of CHF 5259: 50 μg)

Drug: CHF 5259

Treatment D

EXPERIMENTAL

CHF 5259 pMDI 25 μg, 2 inhalations bid; (TDD of CHF 5259: 100 μg)

Drug: CHF 5259

Treatment E

PLACEBO COMPARATOR

Placebo, 2 inhalations of CHF 5259 pMDI-matched Placebo bid;

Drug: Placebo

Treatment F

ACTIVE COMPARATOR

Tiotropium (TIO) 18 μg, SPIRIVA® HandiHaler®, 2 inhalations once daily (od) of the content of 1 capsule; (TDD of TIO: 18 μg)

Drug: Tiotropium Bromide 18 µg Inhalation Capsule

Interventions

CHF 5259 DRUG

Dose Response: Test one of four different doses of CHF 5259

Treatment A; Treatment B; Treatment C; Treatment D

Placebo DRUG

Placebo Control

Treatment E

Tiotropium Bromide 18 µg Inhalation Capsule DRUG

Active Control

Also known as: SPIRIVA® HANDIHALER®

Treatment F

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged ≥ 40 who have signed an Informed Consent Form prior to initiation of any study-related procedure.
• Subjects with a diagnosis of COPD (according to GOLD 2017 Global Strategy for the Diagnosis, Management and Prevention of COPD Report) at least 12 months before the screening visit.
• Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
• A post-bronchodilator forced expiratory volume in the 1st second (FEV1) ≥50% and \<80% of the predicted normal value and,
• a post-bronchodilator FEV1/ Forced Vital Capacity (FVC) \< 0.7 at screening and
• a demonstrated reversibility to ipratropium defined as ΔFEV1 ≥ 5% over baseline 30-45 minutes after inhaling 4 puffs of ipratropium
• Subjects under regular COPD therapy for at least 2 months prior to screening with either inhaled long-acting muscarinic antagonist (LAMA), inhaled ICS/ long-acting β2-agonist (LABA), inhaled ICS + LAMA
• Symptomatic subjects at screening with a CAT score ≥10. This criterion must be confirmed at randomization
• Symptomatic subjects with a BDI focal score ≤ 10. This criterion must be confirmed at randomization
• A cooperative attitude and ability to demonstrate correct use of the inhalers and e-diary.

You may not qualify if:

• Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS they are willing to use highly effective birth control methods
• Diagnosis of asthma or Asthma-COPD Overlap Syndrome (ACOS) as described in global initiative for asthma (GINA) Report 2016, history of allergic rhinitis or atopy (atopy which may raise contra-indications or impact the efficacy of the study treatment according to Investigator's judgment)
• COPD Exacerbations: a moderate or severe COPD exacerbation that has not resolved ≤14 days prior to screening and ≤30 days following the last dose of any oral/systemic corticosteroid or antibiotic (whichever comes last). A Moderate or Severe COPD exacerbation during the run-in period
• Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening or during run-in
• Subjects treated with non-cardio-selective β-blockers in the month preceding screening or during the run-in period
• Subjects treated with long-acting anti-histamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as needed
• Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
• Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according the Investigator's judgment.
• Subjects who have clinically significant cardiovascular condition
• Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement
• Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) \>450 ms for males or QTcF \>470 ms for females at screening visit
• Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would prevent use of anticholinergic agents
• History of hypersensitivity to M3 receptor antagonists, β2-adrenergic receptor agonist, corticosteroids or any of the excipients contained in any of the formulations used in the study which may raise contra-indications or impact the efficacy of the study treatment according to the Investigator's judgement
• Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study treatment according to Investigator's judgement
• Subjects with serum potassium levels \<3.5 mEq/L (or 3.5 mmol/L) at screening

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (112)

Chiesi Investigational Site

Birmingham, Alabama, 35244, United States

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Chiesi Investigational Site

Dothan, Alabama, 36305, United States

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Chiesi Investigational Site

Montgomery, Alabama, 36106, United States

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Chiesi Investigational Site

Flagstaff, Arizona, 86001, United States

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Chiesi Investigational Site

Glendale, Arizona, 85306, United States

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Chiesi Investigational Site

Phoenix, Arizona, 85006, United States

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Chiesi Investigational Site

Phoenix, Arizona, 85014, United States

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Chiesi Investigational Site

Phoenix, Arizona, 85018, United States

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Chiesi Investigational Site

Surprise, Arizona, 85374, United States

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Chiesi Investigational Site

Tempe, Arizona, 85283, United States

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Chiesi Investigational Site

Tucson, Arizona, 85710, United States

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Chiesi Investigational Site

Anaheim, California, 92801, United States

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Chiesi Investigational Site

Escondido, California, 92025, United States

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Chiesi Investigational Site

Fullerton, California, 92835, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

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Chiesi Investigational Site

Long Beach, California, 90806, United States

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Chiesi Investigational Site

Los Angeles, California, 90017, United States

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Chiesi Investigational Site

Los Angeles, California, 90036, United States

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Chiesi Investigational Site

Los Angeles, California, 90048, United States

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Chiesi Investigational Site

Newport Beach, California, 92663, United States

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Chiesi Investigational Site

San Diego, California, 92120, United States

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Chiesi Investigational Site

Tustin, California, 92780, United States

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Chiesi Investigational Site

Westminster, California, 92683, United States

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Chiesi Investigational Site

Boulder, Colorado, 80301, United States

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Chiesi Investigational Site

Centennial, Colorado, 80112, United States

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Chiesi Investigational Site

Denver, Colorado, 80230, United States

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Chiesi Investigational Site

Lafayette, Colorado, 80026, United States

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Chiesi Investigational Site

Brandon, Florida, 33511, United States

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Chiesi Investigational Site

Clearwater, Florida, 33765, United States

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Chiesi Investigational Site

Daytona Beach, Florida, 32117, United States

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Chiesi Investigational Site

Edgewater, Florida, 32132, United States

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Chiesi Investigational Site

Hialeah, Florida, 33012, United States

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Chiesi Investigational Site

Kissimmee, Florida, 34741, United States

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Chiesi Investigational Site

Miami, Florida, 33144, United States

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Chiesi Investigational Site

Miami, Florida, 33165, United States

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Chiesi Investigational Site

Miami, Florida, 33176, United States

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Chiesi Investigational Site

Miami, Florida, 33186, United States

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Chiesi Investigational Site

Orlando, Florida, 32825, United States

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Chiesi Investigational Site

Panama City, Florida, 32405, United States

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Chiesi Investigational Site

Blue Ridge, Georgia, 30513, United States

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Chiesi Investigational Site

Dacula, Georgia, 30019, United States

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Chiesi Investigational Site

Duluth, Georgia, 30096, United States

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Chiesi Investigational Site

Lawrenceville, Georgia, 30046, United States

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Chiesi Investigational Site

Marietta, Georgia, 30060, United States

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Chiesi Investigational Site

Savannah, Georgia, 31405, United States

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Chiesi Investigational Site

Chicago, Illinois, 60607, United States

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Chiesi Investigational Site

Evansville, Indiana, 47714, United States

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Chiesi Investigational Site

Valparaiso, Indiana, 46383, United States

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Chiesi Investigational Site

Louisville, Kentucky, 40215, United States

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Chiesi Investigational Site

Louisville, Kentucky, 40218, United States

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Chiesi Investigational Site

Crowley, Louisiana, 70526, United States

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Chiesi Investigational Site

Lake Charles, Louisiana, 70601, United States

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Chiesi Investigational Site

Lutherville, Maryland, 21093, United States

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Chiesi Investigational Site

Fall River, Massachusetts, 02720, United States

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Chiesi Investigational Site

Fall River, Massachusetts, 02721, United States

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Chiesi Investigational Site

Ann Arbor, Michigan, 48106, United States

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Chiesi Investigational Site

Farmington Hills, Michigan, 48336, United States

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Chiesi Investigational Site

Minneapolis, Minnesota, 55402, United States

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Chiesi Investigational Site

Saint Charles, Missouri, 63301, United States

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Chiesi Investigational Site

St Louis, Missouri, 63141, United States

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Chiesi Investigational Site

Missoula, Montana, 59808, United States

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Chiesi Investigational Site

Omaha, Nebraska, 68114, United States

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Chiesi Investigational Site

Las Vegas, Nevada, 89119, United States

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Chiesi Investigational Site

Summit, New Jersey, 07901, United States

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Chiesi Investigational Site

Albuquerque, New Mexico, 87108, United States

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Chiesi Investigational Site

The Bronx, New York, 10455, United States

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Chiesi Investigational Site

Charlotte, North Carolina, 28207, United States

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Chiesi Investigational Site

Gastonia, North Carolina, 28054, United States

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Chiesi Investigational Site

Hendersonville, North Carolina, 28739, United States

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Chiesi Investigational Site

Mooresville, North Carolina, 28117, United States

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Chiesi Investigational Site

Raleigh, North Carolina, 27607, United States

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Chiesi Investigational Site

Shelby, North Carolina, 28150, United States

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Chiesi Investigational Site

Wilmington, North Carolina, 28401, United States

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Chiesi Investigational Site

Winston-Salem, North Carolina, 27103, United States

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Chiesi Investigational Site

Cincinnati, Ohio, 45242, United States

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Chiesi Investigational Site

Columbus, Ohio, 43213, United States

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Chiesi Investigational Site

Columbus, Ohio, 43215, United States

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Clinical Research Solutions

Dayton, Ohio, 45409, United States

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Chiesi Investigational Site

Grove City, Ohio, 43123, United States

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Chiesi Investigational Site

Edmond, Oklahoma, 73034, United States

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Chiesi Investigational Site

Oklahoma City, Oklahoma, 73103, United States

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Chiesi Investigational Site

Medford, Oregon, 97504, United States

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Chiesi Investigational Site

Portland, Oregon, 97202, United States

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Chiesi Investigational Site

Philadelphia, Pennsylvania, 19140, United States

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Chiesi Investigational Site

East Providence, Rhode Island, 02914, United States

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Chiesi Investigational Site

Anderson, South Carolina, 29621, United States

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Chiesi Investigational Site

Charleston, South Carolina, 29406, United States

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Chiesi Investigational Site

Easley, South Carolina, 29640, United States

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Chiesi Investigational Site

Fort Mill, South Carolina, 29707, United States

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Chiesi Investigational Site

Gaffney, South Carolina, 29340, United States

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Chiesi Investigational Site

Greenville, South Carolina, 29615, United States

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Chiesi Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

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Chiesi Investigational Site

Orangeburg, South Carolina, 29118, United States

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Chiesi Investigational Site

Rock Hill, South Carolina, 29732, United States

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Chiesi Investigational Site

Seneca, South Carolina, 29678, United States

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Chiesi Investigational Site

Spartanburg, South Carolina, 29303, United States

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Chiesi Investigational Site

Union, South Carolina, 29379, United States

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Chiesi Investigational Site

Rapid City, South Dakota, 57702, United States

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Chiesi Investigational Site

Franklin, Tennessee, 37067, United States

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Chiesi Investigational Site

Jackson, Tennessee, 38305, United States

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Chiesi Investigational Site

Knoxville, Tennessee, 37909, United States

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Chiesi Investigational Site

Tullahoma, Tennessee, 37388, United States

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Chiesi Investigational Site

Boerne, Texas, 78006, United States

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Chiesi Investigational Site

Cypress, Texas, 77429, United States

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Chiesi Investigational Site

New Braunfels, Texas, 78130, United States

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Chiesi Investigational Site

Sherman, Texas, 75092, United States

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Chiesi Investigational Site

Tomball, Texas, 77375, United States

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Chiesi Investigational Site

South Burlington, Vermont, 05403, United States

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Chiesi Investigational Site

Richmond, Virginia, 23225, United States

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Chiesi Investigational Site

Everett, Washington, 98208, United States

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Chiesi Investigational Site

Richland, Washington, 99352, United States

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Chiesi Investigational Site

Tacoma, Washington, 98405, United States

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Related Links

• From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
• Chiesi Respiratory
• Chiesi Farmaceutici is the first company to submit a marketing authorisation application to the European Medicine Agency for a Triple Combination for the treatment of COPD
• Glycopyrronium bromide
• American Thoracic Society: Baseline Dyspnea Index (BDI) \& Transition Dyspnea Index (TDI).
• American Thoracic Society: COPD Assessment Test (CAT).

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Inhalation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Study Officials

• Edward Kerwin, MD

  Crisor LLC c/o Clinical Research Institute of Southern Oregon, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 21, 2017
• Study Start: July 28, 2017
• Primary Completion: May 23, 2018
• Study Completion: June 6, 2018
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (112)