CompletedPhase 2

A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects

United States808 participantsStarted 2019-01-02

Plain-language summary

This study will assess the efficacy and safety of multiple dose levels of AZD7594 administered once daily (QD) by inhalation in a 12-week treatment period on asthma subjects. The activity will be assessed by comparing AZD7594 to placebo. The comparison between active comparator (FF) and placebo will be used for bench marking. The efficacy is assessed by the evaluation of change in trough forced expiratory volume in 1 second (FEV1). The aim is to develop AZD7594 as a once daily inhaled non-steroidal selective GR modulator (SGRM), which may ultimately lead to better disease control of both chronic obstructive pulmonary disease (COPD) and asthma through improved efficacy and compliance. The overall rationale for developing a once daily AZD7594 in a dry powder inhaler (DPI) is to provide a safe and effective future treatment option for both asthma and COPD subjects.

Who can participate

Age range18 Years – 85 Years

SexALL

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Exclusion criteria

✕. Known or suspected hypersensitivity to any of the IPs, including budesonide, or excipients, including lactose
✕. Systemic steroid use within the 6 weeks before Visit 1
✕. Concomitant chronic respiratory disease (including current sleep apnea)
✕. History or clinical suspicion of any clinically relevant or active disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study, or any other safety concerns in the opinion of the Investigator
✕. Use of prohibited medications that cannot be stopped during the entire period of the study (starting Visit 1).
✕. Subjects with \<80% eDiary compliance during Run in Period at Visit 3
✕. ACQ-5 of ≥3 at Visit 1, Visit 2, or Visit 3
✕. Daily rescue use of SABA ≥12 puffs for ≥3 consecutive days at any time during Run-in Period, before randomisation

What they're measuring

Change From Baseline in Trough FEV1 at Week 12

Timeframe: At week 12

Trial details

NCT IDNCT03622112

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-30

Results submitted2020-09-24

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