Phase 2
Completed N=54
A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma
Asthma · Efficacy · Safety
Source: ClinicalTrials.gov NCT02479412 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15 — 0.08639; 0.05948; 0.1355; 0.05948 Liters — p=0.6379
Summary
This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled, multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15 |
0.08639; 0.05948; 0.1355; 0.05948; 0.2072; 0.05948 | 0.6379 |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 8 |
-9.153; -4.296; -14.71; -4.296; -19.04; -4.296 | 0.1342 |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 15 |
-14.40; -0.5488; -14.81; -0.5488; -20.44; -0.5488 | 0.0084 sig |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 8 |
0.1016; 0.07112; 0.08856; 0.07112; 0.2272; 0.07112 | 0.6036 |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 15 |
0.04186; 0.07653; 0.1047; 0.07653; 0.1382; 0.0765 | 0.5207 |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 8 |
0.06179; 0.08441; 0.08410; 0.08441; 0.1527; 0.08441 | 0.6945 |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Peak Expiratory Flow (mPEF) Before Administration Over the Treatment Period |
10.42; 0.08136; 5.334; 0.08136; 12.60; 0.08136 | 0.0819 |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Evening Peak Expiratory Flow (ePEF) Before Administration Over the Treatment Period |
7.475; -8.257; 6.040; -8.257; 11.65; -8.257 | 0.0044 sig |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline in Average Daily Use of Rescue Salbutamol Over the Treatment Period |
-0.6776; -0.3340; -0.8193; -0.3340; -1.137; -0.3340 | 0.0723 |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 15 in Asthma Control Questionnaire-5 |
-0.2929; 0.01428; -0.1681; 0.1428; -0.4158; 0.01428 | 0.0044 sig |
| SECONDARY Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 8 in Asthma Control Questionnaire-5 |
-0.2724; -0.1072; -0.1980; -0.1072; -0.3604; -0.1072 | 0.0741 |
| SECONDARY Efficacy of AZD7594 by Assessment of Night-time Awakenings |
-0.4120; 0.006541; -0.1729; 0.006541; -0.7595; 0.006541 | 0.0116 sig |
| SECONDARY Efficacy of AZD7594 by Assessment of Daily Symptom Score |
-0.1190; -0.01229; -0.09435; -0.01229; -0.2150; -0.01229 | 0.0349 sig |
| SECONDARY Efficacy of AZD7594 by Assessment of Asthma Control Days |
0.9502; 0.2773; 0.705; 0.2773; 1.219; 0.2773 | 0.0247 sig |
| SECONDARY Number of Participants With Adverse Events |
17; 13; 9; 12; 3; 1 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Cmax of AZD7594 |
36.40; 92.02; 169.7 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of AUC(0-4) of AZD7594 |
85.02; 188.4; 371.1 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax,ss of AZD7594 |
54.97; 158.7; 421.6 | <0.0001 sig |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24) of AZD7594 |
467.1; 1725; 4894 | <0.0001 sig |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-last) of AZD7594 |
56.85; 188.5; 371.8; 467.3; 1728; 4897 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Tmax of AZD7594 |
0.25; 0.25; 0.25 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Tmax,ss of AZD7594 |
0.25; 0.25; 0.25 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cavg,ss of AZD7594 |
19.48; 71.89; 203.9 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax/D of AZD7594 |
380.8; 223.4; 128.5 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24)/D of AZD7594 |
4886; 4188; 3708 | — |
| SECONDARY Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmin of AZD7594 |
NA; 55.95; 191.6 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index of 18 to 35 kg/m2
- Men and women 18 to 75 years of age, inclusive
- Patients need to be non-smokers or ex-smokers (quit ≥ 6 months before the Visit 1) with total smoking history of 50 years and have been amenorrheic for 12 months or more, following cessation of all exogenous hormonal treatments
- Male patients should be willing to use a condom to prevent pregnancy and exposure of a female partner to AZD7594 and should refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.
Exclusion Criteria
- Known or suspected hypersensitivity to the IMPs or excipients, including lactose
- Systemic steroid use in the 6 weeks before Visit 1
- Any active disease other than asthma
- Patients on medium to high-dose ICS (equivalent of budesonide > 400 μg per day) or on inhaled anticholinergic combination within the 6 weeks prior to Visit 1
- Compliance with the eDiary of at least 80% of the days is expected in both Run-in and Treatment Periods. Patients with < 80% eDiary compliance during Run-in Periods would not be randomized
- Treatment with biologicals such as monoclonal antibodies or chimeric biomolecules including omalizumab within 6 months or 5 half-lives before Visit 1, whichever is longer
- History or clinical suspicion of any clinically relevant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study, or any other safety concerns in the opinion of the Investigator
- ACQ-5 ≥ 3 at any time between Visits 1 and 3
- Any contraindication against the use of vagolytic or sympathomimetic drugs as judged by the Investigator.
- Patients with hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV)
- Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1
- Pregnant woman or a nursing mother
- Suspicion of Gilbert's syndrome
- Vulnerable persons (e.g., persons kept in detention)
- ACQ-5 of ≥ 3 or daily rescue use of ≥ 12 puffs for ≥ 3 consecutive days during the enrollment period
- Hypersensitivity to the active substance or to any of the excipients of the Run-in medication (i.e., budesonide)
Data sourced from ClinicalTrials.gov (NCT02479412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.