A Phase 2b, Randomised, Double-Blind, Placebo Controlled Dose Range Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults with Uncontrolled Asthma at Risk of Exacerbations (LEVANTE).

Conditions

Asthma in adults who remain uncontrolled despite medium to high dose ICS plus LABA, and who are at risk of exacerbations.

Brief summary

Time to first CompEx Asthma event

Detailed description

To evaluate the effect of AZD8630 as compared to placebo on lung function: Change from baseline to: Measured in the clinic: 1 Pre-BD FEV1 2 Post-BD FEV1 3 Pre-BD FEF25-75 4 Pre-BD FVC 5 Post-BD FVC Measured in the home 6. PEF: Weeks 1, 2, 4, 6, 8, 7. maximum pre-BD, To evaluate the effect of AZD8630 as compared to placebo on asthma symptoms, asthma control and quality of life Change from baseline to: 1 Weekly mean asthma symptom diary score: 2 ACQ-6 3 AQLQ+12 4 SGRQ 5 SNOT-22 (for patients with chronic rhinosinusitis with nasal polyposis), To evaluate the effect of AZD8630 as compared with placebo on asthma-related biomarkers Change from baseline to: 1 FeNO 2 Blood eosinophils 3 Total IgE, To evaluate the pharmacokinetics (PK) of AZD8630 and ADA AZD8630 serum concentrations and ADA (incidence and titres).

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGAZD8630

DRUGAZD8630 Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first CompEx Asthma event	—

Secondary

Measure	Time frame
To evaluate the effect of AZD8630 as compared to placebo on lung function: Change from baseline to: Measured in the clinic: 1 Pre-BD FEV1 2 Post-BD FEV1 3 Pre-BD FEF25-75 4 Pre-BD FVC 5 Post-BD FVC Measured in the home 6. PEF: Weeks 1, 2, 4, 6, 8, 7. maximum pre-BD, To evaluate the effect of AZD8630 as compared to placebo on asthma symptoms, asthma control and quality of life Change from baseline to: 1 Weekly mean asthma symptom diary score: 2 ACQ-6 3 AQLQ+12 4 SGRQ 5 SNOT-22 (for patients with chronic rhinosinusitis with nasal polyposis), To evaluate the effect of AZD8630 as compared with placebo on asthma-related biomarkers Change from baseline to: 1 FeNO 2 Blood eosinophils 3 Total IgE, To evaluate the pharmacokinetics (PK) of AZD8630 and ADA AZD8630 serum concentrations and ADA (incidence and titres).	—

Measure

Time frame

To evaluate the effect of AZD8630 as compared to placebo on lung function: Change from baseline to: Measured in the clinic: 1 Pre-BD FEV1 2 Post-BD FEV1 3 Pre-BD FEF25-75 4 Pre-BD FVC 5 Post-BD FVC Measured in the home 6. PEF: Weeks 1, 2, 4, 6, 8, 7. maximum pre-BD, To evaluate the effect of AZD8630 as compared to placebo on asthma symptoms, asthma control and quality of life Change from baseline to: 1 Weekly mean asthma symptom diary score: 2 ACQ-6 3 AQLQ+12 4 SGRQ 5 SNOT-22 (for patients with chronic rhinosinusitis with nasal polyposis), To evaluate the effect of AZD8630 as compared with placebo on asthma-related biomarkers Change from baseline to: 1 FeNO 2 Blood eosinophils 3 Total IgE, To evaluate the pharmacokinetics (PK) of AZD8630 and ADA AZD8630 serum concentrations and ADA (incidence and titres).

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Countries

Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain

Outcome results

None listed