Phase 2
Completed N=305
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
Source: ClinicalTrials.gov NCT01199289 ↗Enrolled (actual)
305
Serious AEs
2.3%
Results posted
Nov 2021
Primary outcomePrimary: Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12 — -0.427; -0.521; -0.512; -0.556 Score on a scale — p=0.5838
Summary
The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12 |
-0.427; -0.521; -0.512; -0.556 | 0.5838 |
| SECONDARY Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
0.075; 0.035; 0.066; 0.058; -0.052; -0.019 | 0.4076 |
| SECONDARY Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12 |
4.26; -14.09; -4.53; -1.95; -0.22; -11.56 | 0.0262 sig |
| SECONDARY Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12 |
-0.630; -0.187; -0.727; -0.798 | 0.5157 |
| SECONDARY Change From Baseline in Daily Asthma Symptom Score to Week 12 |
-1.531; -1.816; -1.629; -1.607 | 0.5577 |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12 |
0.626; 0.596; 0.537; 0.587 | 0.8524 |
| SECONDARY Proportion of Asthma Symptom-free Days |
0.230; 0.167; 0.198; 0.166; 0.201; 0.123 | 0.1213 |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10 |
3.1; 3.1; 3.9 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10 |
8.11; 16.6; 29.4 | — |
| SECONDARY Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10 |
68.3; 171; 313 | — |
Eligibility Criteria
Inclusion Criteria
- Men or women 18 to 65 years of age
- Percent of predicted FEV1 ≥ 50% and ≤ 80%
- At least 12% reversibility over pre-bronchodilator FEV1
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
- Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points
Exclusion Criteria
- Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
- History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)
Data sourced from ClinicalTrials.gov (NCT01199289). 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.