Phase 2
Completed N=70
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
Source: ClinicalTrials.gov NCT01425814 ↗Enrolled (actual)
70
Serious AEs
0.5%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) — -0.035; 0.066; 0.168; 0.198 Liters — p=<0.0001
Summary
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) |
-0.035; 0.066; 0.168; 0.198; 0.223; 0.076 | <0.0001 sig |
| SECONDARY Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve |
-0.003; 0.168; 0.243; 0.247; 0.288; 0.134 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) |
1.475; 1.506; 1.472; 1.483; 1.493; 1.488 | — |
| SECONDARY Absolute Forced Expiratory Volume in One Second (FEV1) Values |
1.475; 1.506; 1.472; 1.483; 1.493; 1.488 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) |
0.098; 0.290; 0.351; 0.350; 0.391; 0.263 | — |
| SECONDARY Time to Peak Forced Expiratory Volume in One Second (FEV1) |
2.5; 3.4; 3.5; 3.7; 4.0; 2.9 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (FVC) |
-0.079; 0.067; 0.180; 0.217; 0.254; 0.088 | — |
| SECONDARY Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve |
0.026; 0.253; 0.297; 0.306; 0.372; 0.237 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) |
3.165; 3.195; 3.137; 3.153; 3.212; 3.190 | — |
| SECONDARY Absolute Forced Vital Capacity (FVC) Values |
3.165; 3.195; 3.137; 3.153; 3.212; 3.190 | — |
| SECONDARY Change From Baseline in Peak Forced Vital Capacity (FVC) |
0.332; 0.484; 0.523; 0.532; 0.575; 0.470 | — |
| SECONDARY Time to Peak Forced Vital Capacity (FVC) |
2.4; 3.6; 3.4; 3.1; 3.6; 2.6 | — |
| SECONDARY Change From Baseline in Inspiratory Capacity (IC) |
2.240; 2.239; 2.234; 2.254; 2.237; 2.246 | — |
| SECONDARY Absolute Inspiratory Capacity (IC) Values |
2.240; 2.239; 2.234; 2.254; 2.237; 2.246 | — |
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant, non-lactating females aged 40 or older.
- Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
- Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
- Post-salbutamol FEV1/FVC < 70% at screening visit.
- Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
- Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
- Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.
Exclusion Criteria
- History or current diagnosis of asthma.
- A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
- Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
- Clinically significant respiratory conditions other than COPD condition.
- 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 (NCT01425814). 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.