AsthmaNCT03028480
Long Term Special Drug Use Investigation of Mepolizumab
An observational study of Asthma, run by GlaxoSmithKline.
Trial summary
This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- NUCALA Injection
- Type of treatment
- Injection or infusion
- How many people
- 1,061 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2017to 22 Nov 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
Who may be able to join
- Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
Who cannot join
- No exclusion criteria
About this study
Official title: Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)
This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies
- Conditions
- Asthma
- Being tested
- NUCALA Injection
- Keywords
- Exacerbation, Mepolizumab, NUCALA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUCALA InjectionDrug
Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Bronchial asthma | Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled Receives: Drug: NUCALA Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System
The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented.
Measured: Up to 14 days from the initiation of NUCALA treatment (Day 1)
Percentage of Participants With Adverse Drug Reaction (ADR)
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Percentage of participants with ADR were calculated as the number of participants having a particular ADR divided by total number of participants on NUCALA treatment*100. Percentage values are rounded-off.
Measured: Up to 3 years
Number of Participants Showing Response to the Treatment
The number of participants who showed response to the bronchial asthma treatment has been presented.
Measured: Up to 1 year
Number of Participants Excluded From Analysis Due to Exacerbation of Asthma
The number of participants excluded from analysis due to exacerbation of asthma has been presented.
Measured: Up to 1 year
Number of Participants With Adverse Drug Reactions (ADR)
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
Measured: Up to 3 years
Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters
Safety specifications and priority investigation matters included hypersensitivity reaction including anaphylaxis, infections, and malignant tumor. The percentage of participants with occurrences of safety specifications and priority investigation matters have been reported. Percentage values are rounded-off.
Measured: Up to 3 years
Secondary outcomes (4)
Response Rate Assessed by Global Assessment of Effectiveness
Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment*100. Percentage values are rounded-off. Response rate and corresponding 95% confidence interval were reported.
Measured: Up to 1 year
Rate of Exacerbation of Asthma
Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in hospitalization, emergency room visit and usage of systemic steroids. Exacerbation rate was defined as number of asthma exacerbations divided by total person-year (52 weeks were converted to 1 year). Data for exacerbations requiring hospitalization, emergency room visit, and use of systemic corticosteroid have been presented.
Measured: 52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatment
Total Score of Asthma Control Test (ACT) at Indicated Time Points
The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled) with higher scores indicating better control. Total ACT score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1).
Measured: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Mean Peak Expiratory Flow (PEF) at Indicated Time Points
Peak Expiratory Flow is a person's maximum speed of expiration. PEF was measured using an electronic peak expiratory flow device (ePEF) at Baseline (Day 1), and at Weeks 12, 24, and 54 after the initiation of NUCALA treatment. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1).
Measured: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start11 Jan 2017
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028480
- Sponsor's protocol ID
- 204524
- Status last verified
- May 2024
- First submitted
- 6 Jan 2017
- Last updated
- 20 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)
- ClinicalTrials.gov ID
- NCT03028480
- Acronym / sponsor ID
- 204524
- Conditions
- Asthma
- Keywords
- Exacerbation, Mepolizumab, NUCALA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,061 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 20 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Bronchial asthma | – | Drug: NUCALA InjectionSubjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
Key inclusion criteria (1 listed)
- Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUCALA InjectionSingle dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion. | Drug | Subjects with Bronchial asthma |
Primary outcome
Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System
Time frame: Up to 14 days from the initiation of NUCALA treatment (Day 1)
The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented.
Percentage of Participants With Adverse Drug Reaction (ADR)
Time frame: Up to 3 years
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Percentage of participants with ADR were calculated as the number of participants having a particular ADR divided by total number of participants on NUCALA treatment*100. Percentage values are rounded-off.
Number of Participants Showing Response to the Treatment
Time frame: Up to 1 year
The number of participants who showed response to the bronchial asthma treatment has been presented.
Number of Participants Excluded From Analysis Due to Exacerbation of Asthma
Time frame: Up to 1 year
The number of participants excluded from analysis due to exacerbation of asthma has been presented.
Number of Participants With Adverse Drug Reactions (ADR)
Time frame: Up to 3 years
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters
Time frame: Up to 3 years
Safety specifications and priority investigation matters included hypersensitivity reaction including anaphylaxis, infections, and malignant tumor. The percentage of participants with occurrences of safety specifications and priority investigation matters have been reported. Percentage values are rounded-off.
4 secondary outcomes
Response Rate Assessed by Global Assessment of Effectiveness
Time frame: Up to 1 year
Rate of Exacerbation of Asthma
Time frame: 52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatment
Total Score of Asthma Control Test (ACT) at Indicated Time Points
Time frame: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Mean Peak Expiratory Flow (PEF) at Indicated Time Points
Time frame: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System (time frame: Up to 14 days from the initiation of NUCALA treatment (Day 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.