Phase 2
Completed N=62
Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
Source: ClinicalTrials.gov NCT01425801 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) — 0.202; 0.477; 0.524; 0.573 Liters — p=<0.0001
Summary
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) |
0.202; 0.477; 0.524; 0.573; 0.608; 0.555 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) |
7.555; 18.282; 20.212; 21.809; 23.077; 21.374 | — |
| SECONDARY Peak Forced Expiratory Volume in One Second (FEV1) |
2.855; 3.129; 3.177; 3.225; 3.260; 3.207 | — |
| SECONDARY Time to Peak Forced Expiratory Volume in One Second (FEV1) |
2.3; 2.6; 3.0; 3.1; 3.0; 1.1 | — |
| SECONDARY Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1) |
-0.054; 0.166; 0.205; 0.278; 0.346; -0.076 | — |
| SECONDARY Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1 |
0.007; 0.282; 0.321; 0.390; 0.446; 0.100 | — |
| SECONDARY Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint |
2.696; 2.863; 2.886; 2.934; 3.007; 3.106 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint |
0.048; 0.214; 0.237; 0.285; 0.358; 0.457 | — |
| SECONDARY Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint |
1.519; 8.325; 8.846; 10.789; 13.511; 17.744 | — |
| SECONDARY Change From Baseline in Peak Forced Vital Capacity (FVC) |
0.222; 0.317; 0.329; 0.361; 0.380; 0.361 | — |
| SECONDARY Peak Forced Vital Capacity (FVC) |
4.483; 4.578; 4.590; 4.622; 4.641; 4.622 | — |
| SECONDARY Time to Peak Forced Vital Capacity (FVC) |
2.1; 1.8; 2.3; 2.1; 2.2; 1.5 | — |
| SECONDARY Change From Baseline to Trough Forced Vital Capacity (FVC) |
-0.028; 0.094; 0.050; 0.111; 0.120; -0.065 | — |
| SECONDARY Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC) |
0.017; 0.135; 0.109; 0.169; 0.192; 0.054 | — |
| SECONDARY Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint |
4.295; 4.420; 4.368; 4.383; 4.417; 4.471 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint |
0.038; 0.162; 0.111; 0.125; 0.159; 0.213 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male and female patients aged 18-70 years (both included).
- Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
- Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
- FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
- Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
- Patients on a stable dose and regimen
Exclusion Criteria
- Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
- Patients diagnosed with COPD.
- Recent Respiratory tract infections within 6 weeks before Screening Visit.
- Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- Clinically significant respiratory conditions.
- Clinically significant cardiovascular conditions.
- Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
Data sourced from ClinicalTrials.gov (NCT01425801). 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.