Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

COPD Clinical Trial

Official title:

A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465567
• Other study ID #: PT010005
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2015
• Est. completion date: July 26, 2019

Study information

• Verified date: January 2021
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

Description:

A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8588
• Est. completion date: July 26, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria

• Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.

• Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS),

• Current or former smokers with a history of at least 10 pack-years of cigarette smoking.

• Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).

• Subjects with history of exacerbations.

Please refer to the study protocol for the complete inclusion criteria list.

Exclusion Criteria

• Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.

• Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.

• Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.

• Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening)

• Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening)

• Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.

• Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.

• Subjects who have a history of hypersensitivity to ß2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.

Please refer to the study protocol for the complete inclusion criteria list.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• BGF MDI 320/14.4/9.6 µg
Budensonide, Glycopyrronium, and Formoterol Fumarate
• GFF MDI 14.4/9.6 µg
Glycopyrronium, and Formoterol Fumarate
• BGF MDI 160/14.4/9.6 µg
Budensonide, Glycopyrronium, and Formoterol Fumarate
• BFF MDI 320/9.6 µg
Budensonide, and Formoterol Fumarate

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United States	Research Site	Morganton	North Carolina
United States	Research Site	Morgantown	West Virginia
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United States	Research Site	Mount Pleasant	South Carolina
United States	Research Site	New Bern	North Carolina
United States	Research Site	New Orleans	Louisiana
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United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
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United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	North Little Rock	Arkansas
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United States	Research Site	O'Fallon	Illinois
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United States	Research Site	Owensboro	Kentucky
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United States	Research Site	Phoenix	Arizona
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United States	Research Site	Pittsburgh	Pennsylvania
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United States	Research Site	Richmond	Virginia
United States	Research Site	Richmond	Virginia
United States	Research Site	Richmond	Virginia
United States	Research Site	Richmond	Virginia
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United States	Research Site	Woodbury	Minnesota
United States	Research Site	Woodstock	Georgia
United States	Research Site	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Chile,  China,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Mexico,  Netherlands,  New Zealand,  Peru,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Rate of Moderate or Severe Exacerbations	Adjusted Rate of Moderate or Severe Exacerbations	52-week treatment period
Secondary	Time to First Moderate or Severe COPD Exacerbation	Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)	52 Weeks
Secondary	Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks	Change from baseline in average daily rescue Ventolin HFA use over 24 weeks	24 Weeks
Secondary	Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score	Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24	at Week 24
Secondary	Time to Death (All Cause)	Subject Deaths (all cause)	52 Weeks
Secondary	Rate of Severe COPD Exacerbations	Rate of severe COPD exacerbations	52 Weeks