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Long Term Special Drug Use Investigation of Mepolizumab
trial testing NUCALA Injection in Asthma in 1,061 participants. Completed in 22 November 2023.
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,061 |
| Start date | 11 January 2017 |
| Primary completion | 22 November 2023 |
| Estimated completion | 22 November 2023 |
GlaxoSmithKline — full company profile →
Eligibility, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 1040 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 4.1 |
The number of participants who showed response to the bronchial asthma treatment has been presented.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 866 |
The number of participants excluded from analysis due to exacerbation of asthma has been presented.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 16 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 42 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 1.2 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 0.3 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 0.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 90.3 | 88.3 – 92.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 0.4 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 0.1 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 0.9 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 0.2 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 3.2 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 0.7 |
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. Bas
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 16.2 | ± 4.9 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 20.5 | ± 4.3 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 20.9 | ± 4.2 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 21.4 | ± 4.0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 304.4 | ± 146.8 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 333.7 | ± 150.5 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 334.2 | ± 138.7 |
| Group | Value | 95% CI |
|---|---|---|
| Participants With Bronchial Asthma | 358.9 | ± 129.8 |
Time frame: All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Participants With Bronchia… |
|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Intraductal papillary-mucinous carcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Myasthenia gravis | Nervous system disorders | — |
| Optic neuropathy | Eye disorders | — |
| Vertigo positional | Ear and labyrinth disorders | — |
| Chronic eosinophilic rhinosinusitis | Respiratory, thoracic and mediastinal disorders | — |
| Angioedema | Skin and subcutaneous tissue disorders | — |
| Condition aggravated | General disorders | — |
| Reaction | System | Participants With Bronchia… |
|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — |
| Urticaria | Skin and subcutaneous tissue disorders | — |
| Chronic eosinophilic rhinosinusitis | Respiratory, thoracic and mediastinal disorders | — |
| Condition aggravated | General disorders | — |
| Headache | Nervous system disorders | — |
| Palpitations | Cardiac disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Malaise | General disorders | — |
| Bronchitis | Infections and infestations | — |
| Nasopharyngitis | Infections and infestations | — |
| Pharyngitis | Infections and infestations | — |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Eczema | Skin and subcutaneous tissue disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Oedema peripheral | General disorders | — |
| Pain | General disorders | — |
| Pyrexia | General disorders | — |
| Eosinophil count increased | Investigations | — |
Most-reported serious reactions: Asthma, Pneumonia, Gastric cancer, Intraductal papillary-mucinous carcinoma of pancreas, Myasthenia gravis, Optic neuropathy, Vertigo positional, Chronic eosinophilic rhinosinusitis.
Data from ClinicalTrials.gov NCT03028480 adverse events section.
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
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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