Tezepelumab COPD Exacerbation Study (COURSE)
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| ClinicalTrials.gov Identifier: NCT04039113 |
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Recruitment Status :
Active, not recruiting
First Posted : July 31, 2019
Last Update Posted : March 30, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Biological: Tezepelumab Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 337 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double-blinded |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE) |
| Actual Study Start Date : | July 30, 2019 |
| Estimated Primary Completion Date : | November 16, 2023 |
| Estimated Study Completion Date : | February 8, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Tezepelumab
Tezepelumab, SC, Q4W
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Biological: Tezepelumab
Tezepelumab subcutaneous injection |
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Placebo Comparator: Matching Placebo
Matching placebo, SC, Q4W
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Other: Placebo
Placebo subcutaneous injection |
- Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo) [ Time Frame: Over 52 Weeks ]The exacerbation rate is based on exacerbations reported by the investigator over 52 weeks.
- Time to first moderate or severe COPD exacerbation [ Time Frame: By Week 52 ]Time to first occurrence of moderate/severe exacerbation post randomization. Outcome measures: Hazard ratio
- Proportion with at least one moderate/severe COPD exacerbation [ Time Frame: Over 52 Weeks ]Proportion of subjects with at least one moderate/severe exacerbation reported by the Investigator over 52 weeks Outcome measure: Odds Ratio
- Severe COPD exacerbation rate ratio (tezepelumab vs. placebo) [ Time Frame: Over 52 Weeks ]The severe exacerbation rate is based on severe exacerbations reported by the Investigator over 52 weeks.
- Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, Week 52 ]
Difference in change from baseline in pre-BD forced expiratory volume in 1 second (FEV1) in tezepelumab arm as compared to placebo at Week 52.
FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration.
- Change in respiratory health status/health-related quality of life [ Time Frame: Baseline, Week 52 ]
Proportion of subjects achieving a decrease of 4 units or more in the St. George's Respiratory Questionnaire (SGRQ) total score at Week 52, i.e. minimum clinically important difference (MCID).
Outcome measure: odds ratio
- Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: Baseline, Week 52 ]
Difference (tezepelumab vs. placebo) in SGRQ from baseline at Week 52.
SGRQ is a 50-item patient reported outcome questionnaire. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0% indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment. Decrease of 4 units is associated with a minimum clinically important difference (MCID).
- Change from baseline in the COPD Assessment Test (CAT) Total Score [ Time Frame: Baseline, Week 52 ]
Difference (tezepelumab vs. placebo) in COPD assessment tool (CAT) from baseline at Week 52.
CAT is an 8-item patient reported outcome questionnaire developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. The score ranges from 0 to 40, with higher scores indicating greater COPD impact on health status.
- Evaluate pharmacokinetics of tezepelumab [ Time Frame: Weeks 0, 4, 12, 24, 36, 52, 64 ]Serum trough concentration of tezepelumab
- Evaluate immunogenicity of tezepelumab [ Time Frame: Over 52 weeks ]Incidence of anti-drug antibodies (ADA)
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
- History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
- CAT score of ≥15 at enrollment and on day of randomization.
- Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment.
Exclusion Criteria:
- Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
- Major surgery within 8 weeks before enrollment.
- History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
- Pregnant or breastfeeding.
- The chest/lungs with pathology that precludes the patient's ability to complete the study
- The patient has active COVID 19 infection during screening period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039113
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| Principal Investigator: | Dave Singh, MD | Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT04039113 |
| Other Study ID Numbers: |
D5241C00001 |
| First Posted: | July 31, 2019 Key Record Dates |
| Last Update Posted: | March 30, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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COPD Moderate COPD Severe COPD chronic obstructive pulmonary disease |
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Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases |
Chronic Disease Disease Attributes Pathologic Processes |