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CompletedNCT02465567Updated Feb 2, 2021Results posted

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

A Phase 3 interventional study of BGF MDI 320/14.4/9.6 μg and GFF MDI 14.4/9.6 μg in COPD, sponsored by Pearl Therapeutics, Inc.. Completed at 741 sites in 26 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by Pearl Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
8,588
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • COPD
03

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 β2-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.

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8,588 participants (actual)

Study arms

  • Experimental
    BGF (PT010) MDI 320/14.4/9.6 μg

    BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])

    Drug: BGF MDI 320/14.4/9.6 μg

  • Experimental
    BGF (PT010) MDI 160/14.4/9.6 μg

    BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])

    Drug: BGF MDI 160/14.4/9.6 μg

  • Experimental
    BFF (PT009) MDI 320/9.6 μg

    BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)

    Drug: BFF MDI 320/9.6 μg

  • Experimental
    GFF (PT003) MDI 14.4/9.6 μg

    GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)

    Drug: GFF MDI 14.4/9.6 μg

Interventions

  • DrugBGF MDI 320/14.4/9.6 μg

    Budensonide, Glycopyrronium, and Formoterol Fumarate

    Also known as: BGF

  • DrugGFF MDI 14.4/9.6 μg

    Glycopyrronium, and Formoterol Fumarate

    Also known as: GFF

  • DrugBGF MDI 160/14.4/9.6 μg

    Budensonide, Glycopyrronium, and Formoterol Fumarate

    Also known as: BGF

  • DrugBFF MDI 320/9.6 μg

    Budensonide, and Formoterol Fumarate

    Also known as: BFF

05

What researchers measure

Primary outcomes

  1. Adjusted Rate of Moderate or Severe Exacerbations

    Adjusted Rate of Moderate or Severe Exacerbations

    Time frame: 52-week treatment period

Secondary outcomes

  1. 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)

    Time frame: 52 Weeks

  2. 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

    Time frame: 24 Weeks

  3. 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

    Time frame: at Week 24

  4. Time to Death (All Cause)

    Subject Deaths (all cause)

    Time frame: 52 Weeks

  5. Rate of Severe COPD Exacerbations

    Rate of severe COPD exacerbations

    Time frame: 52 Weeks

06

Results

Posted Feb 2, 2021

Participant flow

This study was conducted in 26 countries between July 2015 and July 2019.

Participant flow — Overall Study
MilestoneBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Started2157213721432151
Completed1708171315801643
Not completed449424563508
Withdrew: Adverse event118113147138
Withdrew: Lack of efficacy103102171135
Withdrew: Withdrawal by subject10494123130
Withdrew: Physician decision23333828
Withdrew: Major protocol deviation24262225
Withdrew: Lost to follow-up25211915
Withdrew: Protocol specified criteria2010912
Withdrew: Administrative reasons129115
Withdrew: Randomized but not treated1545
Withdrew: Enrolled in >1 studies18111915
Withdrew: Missing pi signature1000

Outcome measures

PrimaryAdjusted Rate of Moderate or Severe Exacerbations

Adjusted Rate of Moderate or Severe Exacerbations

Time frame:
52-week treatment period
Reported as:
Least squares mean · Moderate or Severe Exacerbations
Adjusted Rate of Moderate or Severe Exacerbations
Moderate or Severe ExacerbationsBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Adjusted Rate of Moderate or Severe Exacerbations1.08 ± 0.041.07 ± 0.041.42 ± 0.051.24 ± 0.04
Statistical analysis
  • BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Negative Binomial Regression · p = <0.0001 · Rate ratio: 0.76 · 95% CI 0.69 to 0.83
  • BGF MDI 320/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Negative Binomial Regression · p = 0.0027 · Rate ratio: 0.87 · 95% CI 0.79 to 0.95
  • BGF MDI 160/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Negative Binomial Regression · p = <0.0001 · Rate ratio: 0.75 · 95% CI 0.69 to 0.83
  • BGF MDI 160/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Negative Binomial Regression · p = 0.0020 · Rate ratio: 0.86 · 95% CI 0.79 to 0.95
SecondaryTime 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)

Time frame:
52 Weeks
Reported as:
Count of participants · Participants
Time to First Moderate or Severe COPD Exacerbation
ParticipantsBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Time to First Moderate or Severe COPD Exacerbation1026101310561085
Statistical analysis
  • BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Regression, Cox · p = 0.0035 · Hazard ratio (hr): 0.880 · 95% CI 0.807 to 0.959
  • BGF MDI 320/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Regression, Cox · p = 0.057 · Hazard ratio (hr): 0.887 · 95% CI 0.814 to 0.966
  • BGF MDI 160/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Regression, Cox · p = 0.0011 · Hazard ratio (hr): 0.866 · 95% CI 0.794 to 0.944
  • BGF MDI 160/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Regression, Cox · p = 0.0019 · Hazard ratio (hr): 0.873 · 95% CI 0.801 to 0.951
SecondaryChange 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

Time frame:
24 Weeks
Reported as:
Least squares mean · Puffs
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks
PuffsBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks-1.2 (-1.3 to -1.1)-1.0 (-1.2 to -0.9)-0.7 (-0.8 to -0.5)-0.8 (-0.9 to -0.7)
Statistical analysis
  • BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Linear Repeated Measures · p = <0.0001 · Mean difference (final values): -0.51 · 95% CI -0.68 to -0.34
  • BGF MDI 320/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Linear Repeated Measures · p = <0.0001 · Mean difference (final values): -0.37 · 95% CI -0.54 to -0.20
  • BGF MDI 160/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Linear Repeated Measures · p = <0.0001 · Mean difference (final values): -0.35 · 95% CI -0.53 to -0.18
  • BGF MDI 160/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Linear Repeated Measures · p = 0.0127 · Mean difference (final values): -0.22 · 95% CI -0.39 to -0.05
SecondaryPercentage 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

Time frame:
at Week 24
Reported as:
Count of participants · Participants
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score
ParticipantsBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score10681024893949
Statistical analysis
  • BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Regression, Logistic · p = <0.0001 · Odds ratio (or): 1.358 · 95% CI 1.199 to 1.539
  • BGF MDI 320/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Regression, Logistic · p = 0.0005 · Odds ratio (or): 1.246 · 95% CI 1.100 to 1.410
  • BGF MDI 160/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Regression, Logistic · p = <0.0004 · Odds ratio (or): 1.283 · 95% CI 1.133 to 1.454
  • BGF MDI 160/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Regression, Logistic · p = 0.0103 · Odds ratio (or): 1.177 · 95% CI 1.039 to 1.333
SecondaryTime to Death (All Cause)

Subject Deaths (all cause)

Time frame:
52 Weeks
Reported as:
Count of participants · Participants
Time to Death (All Cause)
ParticipantsBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Time to Death (All Cause)28394934
Statistical analysis
  • BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Regression, Cox · p = 0.0111 · Hazard ratio (hr): 0.544 · 95% CI 0.340 to 0.870
  • BGF MDI 320/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Regression, Cox · p = 0.3401 · Hazard ratio (hr): 0.782 · 95% CI 0.472 to 1.296
  • BGF MDI 160/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Regression, Cox · p = 0.2690 · Hazard ratio (hr): 0.789 · 95% CI 0.518 to 1.201
  • BGF MDI 160/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Regression, Cox · p = 0.5918 · Hazard ratio (hr): 1.134 · 95% CI 0.716 to 1.796
SecondaryRate of Severe COPD Exacerbations

Rate of severe COPD exacerbations

Time frame:
52 Weeks
Reported as:
Least squares mean · Severe Exacerbations
Rate of Severe COPD Exacerbations
Severe ExacerbationsBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Rate of Severe COPD Exacerbations0.13 ± 0.010.14 ± 0.010.15 ± 0.010.16 ± 0.01
Statistical analysis
  • BGF MDI 320/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Negative Binomial Regression · p = 0.6552 · Rate ratio: 0.84 · 95% CI 0.69 to 1.03
  • BGF MDI 320/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Negative Binomial Regression · p = 0.0221 · Rate ratio: 0.80 · 95% CI 0.66 to 0.97
  • BGF MDI 160/14.4/9.6 μg vs GFF MDI 14.4/9.6 μg · Negative Binomial Regression · p = 0.2157 · Rate ratio: 0.88 · 95% CI 0.72 to 1.08
  • BGF MDI 160/14.4/9.6 μg vs BFF MDI 320/9.6 μg · Negative Binomial Regression · p = 0.0647 · Rate ratio: 0.83 · 95% CI 0.69 to 1.01

Adverse events

Collected over Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BGF MDI 320/14.4/9.6 μg27/2,144 (1.3%)426/2,144 (19.9%)337/2,144 (15.7%)
BGF MDI 160/14.4/9.6 μg42/2,124 (2%)445/2,124 (21%)361/2,124 (17%)
GFF MDI 14.4/9.6 μg47/2,125 (2.2%)433/2,125 (20.4%)292/2,125 (13.7%)
BFF MDI 320/9.6 μg35/2,136 (1.6%)440/2,136 (20.6%)336/2,136 (15.7%)
Most frequent serious events
Showing 10 of 476
Most frequent serious events
EventBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders202/2144221/2124219/2125241/2136
PneumoniaInfections and infestations61/214459/212435/212555/2136
Acute respiratory failureRespiratory, thoracic and mediastinal disorders14/214420/212420/21257/2136
Acute myocardial infarctionCardiac disorders7/214410/212417/21257/2136
Atrial fibrilationCardiac disorders9/21448/212414/21253/2136
Respiratory failureRespiratory, thoracic and mediastinal disorders10/21449/21245/21259/2136
Cardiac arrestCardiac disorders3/21441/21248/21250/2136
Cerebrovascular accidentNervous system disorders8/21442/21244/21253/2136
Myocardial infarctionCardiac disorders5/21445/21247/21254/2136
Coronary artery diseaseCardiac disorders5/21445/21247/21251/2136
Most frequent other events
Most frequent other events
EventBGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μg
NasopharyngitisInfections and infestations227/2144239/2124199/2125234/2136
Upper respiratory tract infectionInfections and infestations123/2144137/2124102/2125115/2136

Baseline characteristics

mITT population

Age, Continuous
Age, Continuous(Years)BGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μgTotal
Mean64.6 ± 7.664.6 ± 7.664.8 ± 7.664.6 ± 7.664.7 ± 7.6
Sex: Female, Male
Sex: Female, Male(Participants)BGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μgTotal
Female8778238768523428
Male12601298124412795081
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μgTotal
Hispanic or Latino4003934264011620
Not Hispanic or Latino16901680164916836702
Unknown or Not Reported47484547187
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BGF MDI 320/14.4/9.6 μgBGF MDI 160/14.4/9.6 μgGFF MDI 14.4/9.6 μgBFF MDI 320/9.6 μgTotal
American Indian or Alaska Native33403039142
Asian162166157166651
Native Hawaiian or Other Pacific Islander20002
Black or African American78887564305
White18191783180818167226
More than one race00000
Unknown or Not Reported43445046183
07

Study locations

741 sites
  • Research Site
    Andalusia, Alabama 36420, United States
  • Research Site
    Athens, Alabama 35611, United States
  • Research Site
    Birmingham, Alabama 35209, United States
  • Research Site
    Birmingham, Alabama 35235, United States
  • Research Site
    Birmingham, Alabama 35243, United States
  • Research Site
    Dothan, Alabama 36303, United States
  • Research Site
    Florence, Alabama 35630, United States
  • Research Site
    Foley, Alabama 36535, United States
  • Research Site
    Gulf Shores, Alabama 36542, United States
  • Research Site
    Jasper, Alabama 35501, United States
  • Research Site
    Mobile, Alabama 36608, United States
  • Research Site
    Montgomery, Alabama 36106, United States
  • Research Site
    Scottsboro, Alabama 35768, United States
  • Research Site
    Sheffield, Alabama 35660, United States
  • Research Site
    Peoria, Arizona 85381, United States
  • Research Site
    Phoenix, Arizona 85012, United States
  • Research Site
    Phoenix, Arizona 85018, United States
  • Research Site
    Phoenix, Arizona 85020, United States
  • Research Site
    Scottsdale, Arizona 85258, United States
  • Research Site
    Conway, Arkansas 72032, United States
  • Research Site
    Little Rock, Arkansas 72205, United States
  • Research Site
    Little Rock, Arkansas 72209, United States
  • Research Site
    North Little Rock, Arkansas 72117, United States
  • Research Site
    Bakersfield, California 93301, United States
  • Research Site
    Beverly Hills, California 90212, United States
  • Research Site
    Cerritos, California 90703, United States
  • Research Site
    El Cajon, California 92020, United States
  • Research Site
    Escondido, California 92025, United States
  • Research Site
    Fresno, California 93702, United States
  • Research Site
    Gold River, California 95670, United States
  • Research Site
    Hawaiian Gardens, California 90716, United States
  • Research Site
    Huntington Beach, California 92647, United States
  • Research Site
    Huntington Park, California 90255-6046, United States
  • Research Site
    La Mirada, California 90638, United States
  • Research Site
    Lakewood, California 90712, United States
  • Research Site
    Los Angeles, California 90017, United States
  • Research Site
    Los Angeles, California 90025, United States
  • Research Site
    Los Angeles, California 90036, United States
  • Research Site
    Los Angeles, California 90048, United States
  • Research Site
    Newport Beach, California 92663, United States
  • Research Site
    Northridge, California 91324, United States
  • Research Site
    Palm Springs, California 92262, United States
  • Research Site
    Poway, California 92064, United States
  • Research Site
    Quartz Hill, California 93536, United States
  • Research Site
    Rancho Mirage, California 92270, United States
  • Research Site
    Riverside, California 92506, United States
  • Research Site
    Rolling Hills Estates, California 90274, United States
  • Research Site
    Sacramento, California 95821, United States
  • Research Site
    Sacramento, California 95823, United States
  • Research Site
    Sacramento, California 95831, United States
  • Research Site
    San Diego, California 92117, United States
  • Research Site
    San Diego, California 92120, United States
  • Research Site
    Santa Ana, California 92704, United States
  • Research Site
    Santa Ana, California 92705, United States
  • Research Site
    Santa Monica, California 90404, United States
  • Research Site
    Stockton, California 95207, United States
  • Research Site
    Torrance, California 90503, United States
  • Research Site
    Tustin, California 92780, United States
  • Research Site
    Upland, California 91786, United States
  • Research Site
    Westminster, California 92683, United States
  • Research Site
    Wildomar, California 92595, United States
  • Research Site
    Colorado Springs, Colorado 80910, United States
  • Research Site
    Colorado Springs, Colorado 80922, United States
  • Research Site
    Fort Collins, Colorado 80525, United States
  • Research Site
    Lafayette, Colorado 80026, United States
  • Research Site
    Boynton Beach, Florida 33435, United States
  • Research Site
    Brandon, Florida 33511, United States
  • Research Site
    Clearwater, Florida 33756, United States
  • Research Site
    Clearwater, Florida 33765, United States
  • Research Site
    Clermont, Florida 34711, United States
  • Research Site
    Coral Gables, Florida 33134, United States
  • Research Site
    Daytona Beach, Florida 32117, United States
  • Research Site
    Fort Lauderdale, Florida 33308, United States
  • Research Site
    Gainesville, Florida 32607, United States
  • Research Site
    Hialeah, Florida 33012, United States
  • Research Site
    Hialeah, Florida 33029, United States
  • Research Site
    Hollywood, Florida 33024, United States
  • Research Site
    Homestead, Florida 33030, United States
  • Research Site
    Kissimmee, Florida 34741, United States
  • Research Site
    Kissimmee, Florida 34744, United States
  • Research Site
    Leesburg, Florida 34748, United States
  • Research Site
    Loxahatchee Groves, Florida 33470, United States
  • Research Site
    Miami Lakes, Florida 33014, United States
  • Research Site
    Miami, Florida 33012, United States
  • Research Site
    Miami, Florida 33125, United States
  • Research Site
    Miami, Florida 33126, United States
  • Research Site
    Miami, Florida 33144, United States
  • Research Site
    Miami, Florida 33155, United States
  • Research Site
    Miami, Florida 33165, United States
  • Research Site
    Miami, Florida 33174, United States
  • Research Site
    Miami, Florida 33175, United States
  • Research Site
    Miami, Florida 33186, United States
  • Research Site
    Ormond Beach, Florida 32174, United States
  • Research Site
    Panama City, Florida 32405, United States
  • Research Site
    Pembroke Pines, Florida 33029, United States
  • Research Site
    Pensacola, Florida 32503, United States
  • Research Site
    Port Charlotte, Florida 33952, United States
  • Research Site
    Saint Petersburg, Florida 33704, United States
  • Research Site
    Saint Petersburg, Florida 33707, United States
  • Research Site
    Saint Petersburg, Florida 33710, United States

Showing the first 100 of 741 sites across 26 countries.

08

References and documents

Publications

  • Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314. PubMed 35815359 ↗
  • Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7. PubMed 35614467 ↗
  • Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24. PubMed 32579807 ↗
  • Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22. PubMed 31605923 ↗

Study documents

  • Study protocol · Jun 21, 2019
  • Statistical analysis plan · Apr 30, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT02465567
Lead sponsor
Pearl Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jun 8, 2015
Start date
Jun 30, 2015
Primary completion
Jul 26, 2019
Completion
Jul 26, 2019
Results posted
Feb 2, 2021
Last update
Feb 2, 2021

Study contacts

Paul M Dorinsky, MD
study director · Pearl Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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