CompletedPhase 2

A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations

United States537 participantsStarted 2024-08-30

Plain-language summary

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patient must be 18 to 80 years of age inclusive
✓. Documented physician diagnosis of asthma for at least 12 months, with objective evidence of asthma (spirometric, bronchial challenge, exercise challenge or therapeutic response) within the last 5 years

Exclusion criteria

✕. History of life-threatening asthma
✕. Recently completed treatment for respiratory infection and/or asthma exacerbation
✕. Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease.
✕. Any disorder that is not stable in the opinion of the Investigator and could:
✕. Affect the safety of the patient throughout the study
✕. Influence the findings of the study or their interpretation
✕. Impede the patient's ability to complete the entire duration of study
✕. Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.

What they're measuring

Time to first CompEx Asthma event

Timeframe: 12 weeks

Trial details

NCT IDNCT06529419

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-04

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