Phase 3
Completed N=8,588
Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
Source: ClinicalTrials.gov NCT02465567 ↗Enrolled (actual)
8,588
Serious AEs
20.5%
Results posted
Feb 2021
Primary outcomePrimary: Adjusted Rate of Moderate or Severe Exacerbations — 1.08; 1.07; 1.42; 1.24 Moderate or Severe Exacerbations — p=<0.0001
◆ Published Evidence
Highly cited
685citations · ~114 / year
Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD.
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.
Linked Publications (5)
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Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD.
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Predictive modeling of COPD exacerbation rates using baseline risk factors.
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Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study.
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Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS.
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Impact of Increased Use of Single-Inhaler Triple Therapies on COPD Exacerbation Rates, Mortality, and Total Costs: PROMETHEUS France.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Rate of Moderate or Severe Exacerbations |
1.08; 1.07; 1.42; 1.24 | <0.0001 sig |
| SECONDARY Time to First Moderate or Severe COPD Exacerbation |
1026; 1013; 1056; 1085 | 0.0035 sig |
| SECONDARY Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks |
-1.2; -1.0; -0.7; -0.8 | <0.0001 sig |
| SECONDARY Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score |
1068; 1024; 893; 949 | <0.0001 sig |
| SECONDARY Time to Death (All Cause) |
28; 39; 49; 34 | 0.0111 sig |
| SECONDARY Rate of Severe COPD Exacerbations |
0.13; 0.14; 0.15; 0.16 | 0.6552 |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02465567) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.