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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

A fixed 300 mg dose every 2 weeks (Q2W) of tralokinumab administered subcutaneously in subjects with inadequately controlled asthma on medium to high-dose of inhaled corticosteroid plus long-acting β2-agonist.

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

A Study to Evaluate the  Safety of Tralokinumab in Adults and Adolescents with Uncontrolled Asthma

This is a 52-week, open-label, multi-centre study designed to evaluate the safety of tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid plus long acting β-2 antagonist.  Approximately 26 Japanese subjects will be recruited to receive 22 completed.

NCT ID

Patient Level Data

Therapeutic Area

Subcutaneous injection; fixed dose; 300 mg

Research Site

To assess the safety and tolerability of tralokinumab.

Age Continuous

Age Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

The safety analysis set included all participants enrolled and who received at least 1 dose of investigational product irrespective of their protocol adherence and continued participation in the study.

Study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings of laboratory variables, physical examinations, vitals and ECG were evaluated for safety signal.

Any AE

Any AE with outcome of death

Any SAE (including events with outcome of death)

Any AE leading to discontinuation of study drug

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.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

No participants were analysed as the study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings of clinical laboratory parameters were evaluated for safety signal.

Number of Participants With Clinical Laboratory Abnormalities

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.

The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. Any new finding(s) or aggravated existing finding(s), judged as clinically significant by the Investigator, were reported as an AE.

Number of Participants With Abnormal Physical Examinations

Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.

The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. No summary table was developed.

Number of Participants With Vital Signs 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.

Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities

Overall Study

Of all enrolled participants, 3 were considered screen failures and 28 participants were received study treatment. Following initial screening, there was a run-in period of up to 2 weeks to allow adequate time for eligibility criteria to be evaluated prior to entry to planned 52-week treatment period followed by a 14 week extended follow-up period.

A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents with Uncontrolled Asthma

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Statistical Analysis Plan

Clinical Study Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator