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Name (Synonyms) | Correlation | |
---|---|---|
drug796 | COVID-19 Androgen Sensitivity Test (CoVAST) Wiki | 1.00 |
drug3737 | Run-in medications (ICS-LABA combination) Wiki | 1.00 |
drug173 | AZD1402 Wiki | 1.00 |
Navigate: Correlations HPO
There is one clinical trial.
This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a lead-in cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 (separate inhalers or combination product) and medium dose ICS-LABA as a combination product for Part 2 at Screening. Part 2 will be initiated for each dose level following evaluation of safety and PK at the relevant dose level in Part 1. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.
Description: To evaluate the safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA. Safety and tolerability variables included AEs/ adverse events of special interest (AESIs) / serious adverse events (SAEs), vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, Electrocardiograms (ECGs), Forced expiratory volume in 1 second (FEV1) and fractional exhaled nitric oxide (FeNO).
Measure: Part 1: Number of participants with adverse events (AEs) Time: From Day 1 until Follow-up (Day 56 ± 4)Description: To investigate the efficacy of inhaled AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.
Measure: Part 2: Change from baseline in pre-bronchodilator FEV1 at Week 4 Time: Baseline and Week 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Maximum observed serum (peak) drug concentration (Cmax) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Time to reach peak or maximum observed concentration or response following drug administration (tmax) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Observed lowest drug concentration reached before the next dose is administered (pre-dose) (Ctrough) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Area under plasma concentration-time curve in the dosing interval (AUCτ) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Area under the plasma concentration time curve in the dosing interval τ divided by the dose administered (Dose normalised AUCτ) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Time of last observed (quantifiable) concentration (tlast) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Accumulation ratio for AUCτ (Rac AUC) Time: Day 1 until Day 56 ± 4Description: To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).
Measure: Part 1 and Part 2: Accumulation ratio for Cmax (Rac Cmax) Time: Day 1 until Day 56 ± 4Description: To investigate the immunogenicity of AZD1402.
Measure: Part 1 and Part 2: Antidrug antibodies (ADA) titers testing for all ADA-positive samples as measure of immunogenicity Time: Day 1 until Day 56 ± 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.
Measure: Part 2: Change from baseline in pre bronchodilator FEV1 average over the 4-week Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.
Measure: Part 2: Change from baseline in post bronchodilator FEV1 average over the 4-week Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.
Measure: Part 2: Change from baseline in Asthma control questionnaire-6 (ACQ-6) at Week 4 and average over the Treatment Period Time: Baseline, Week 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.
Measure: Part 2: Proportion of participants with a decrease in ACQ 6 score of ≥ 0.5 from baseline to Week 4 Time: Baseline, Week 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in asthmatics who are uncontrolled on medium dose ICS-LABA. The SGRQ is a 50-item instrument developed to measure the health status of participants with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents 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.
Measure: Part 2: Change from baseline in St. George's respiratory questionnaire (SGRQ) score to Week 4 Time: Baseline, Week 4Description: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.
Measure: Part 2: Change from baseline in average morning Peak expiratory flow (PEF) over the Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.
Measure: Part 2: Change from baseline in average evening PEF over the Treatment Period Time: Baseline, 4 weeksDescription: To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Severity scores for asthma symptoms will be recorded twice daily in the morning and evening and documented in the e-Diary. Asthma symptom scores during night-time and day-time will be assessed by the participant each morning and evening according to the following scoring system: 0: You have no asthma symptoms. You are aware of your asthma symptoms but you can easily tolerate the symptoms. Your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep). You are unable to do your normal activities (or to sleep) because of your asthma. Higher scores indicated worse outcome.
Measure: Part 2: Change from baseline in daily average asthma symptom score (AM/PM) over the Treatment Period Time: Baseline, 4 weeksDescription: To investigate the effect of AZD1402 compared to placebo on airway inflammation in adults with asthma who are uncontrolled on medium dose ICS-LABA. To investigate the effect of AZD1402 on airway inflammation, the measurement of FeNO will be performed in accordance with ATS/ERS guidelines. Standardised conditions with regard to exhalation flow rate and duration of exhalation will be followed such that plateau definition can be evaluated over a minimum of 3 seconds. The concentration of FeNO will be measured in units of part per billion (ppb).
Measure: Part 2: Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 4 and average over the Treatment Period Time: Baseline, Week 4Description: To evaluate the safety and tolerability of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Safety and tolerability variables included AEs/AESIs/SAEs, vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, ECGs, FEV1 and FeNO.
Measure: Part 2: Number of participants with adverse events (AEs) Time: From Day 1 until the Follow-up (Day 56 ± 4)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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