Inadequately Controlled Asthma Clinical Trial
Official title:
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
| Verified date | July 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist
| Status | Terminated |
| Enrollment | 28 |
| Est. completion date | January 19, 2018 |
| Est. primary completion date | January 19, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Age 12 - 75 yrs 2. Documented physician-diagnosed asthma 3. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to =500 µg fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA) 4. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of =40% of their Predicted Normal Value (PNV) 5. Asthma Control Questionnaire-6 (ACQ-6) score =1.5 Exclusion Criteria: 1. Pulmonary disease other than asthma 2. History of anaphylaxis following any biologic therapy 3. Hepatitis B, C or HIV 4. Pregnant of breastfeeding 5. History or cancer 6. Current tobacco smoking or a history or tobacco smoking for =10 pack-years 7. Previous receipt of tralokinumab |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Itabashi-ku | |
| Japan | Research Site | Yokohama-shi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to product. An undesirable medical condition can be symptoms, signs or the abnormal results of an investigation. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered. A SAE was an AE occurred during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening, in-patient or prolongation of existing hospitalization; persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; congenital abnormality or birth defect; important medical event that may jeopardise participant or may require medical intervention to prevent one of the outcomes listed above. | From Screening (Day -14) up to 14 weeks after end of treatment (Week 66). | |
| Primary | Number of Participants With Clinical Laboratory Abnormalities | Blood and urine samples for determination of clinical chemistry, haematology and urinalysis parameters were taken at the times. Changes in haematology and clinical chemistry variables between baseline and each subsequent scheduled assessment were evaluated. Baseline is defined as the last available value measured prior to the first dose of study treatment. The change from baseline is defined as the treatment period value minus the baseline period value. Absolute values were compared to the relevant reference range and classified as low (below range), normal (within range or on limits) or high (above range). The AstraZeneca extended reference ranges were used for laboratory variables (where they exist). All values (absolute and change) falling outside the reference ranges were flagged. Urinalysis data were categorised as negative (0), trace or positive (+) at each time point. | From Screening (Day -14) up to 14 weeks after end of treatment (Week 66). | |
| Primary | Number of Participants With Abnormal Physical Examinations | Physical examination included assessment of general appearance, skin, head and neck (including eyes, ears, nose, mouth and throat), lymph nodes, abdomen, musculoskeletal (including spine and extremities), cardiovascular, respiratory, and neurological systems. Criteria for abnormal physical findings were based on investigator's discretion. | From Screening (Day -14) up to 14 weeks after end of treatment (Week 66). | |
| Primary | Number of Participants With Vital Signs Abnormalities | Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature. | From Screening (Day -14) up to 14 weeks after end of treatment (Week 66). | |
| Primary | Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities | The ECG assessments were performed using an ECG device prior to blood drawing, spirometry, investigational product administration and bronchodilator administration. ECG data and evaluation was planned to be performed by the site Investigator. | At Day -14 and Week 52. |