Stable moderate to severe chronic obstructive pulmonary disease (COPD) MedDRA version: 13.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: LAS100977 - 0.625 µg
Pharmaceutical Form: Inhalation powder
Current Sponsor code: LAS100977
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 0.625-
Pha
Sponsors
Almirall S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females aged 40 or older. 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction. 3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value 4. Post-salbutamol FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. History or current diagnosis of asthma. 2. A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit. 3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit. 4. Clinically significant respiratory conditions other than COPD condition. 5. Clinically significant cardiovascular conditions. 6. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry. 7. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator’s opinion, preclude study participation. 8. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the pharmacodynamics (bronchodilation) of 3 single doses of inhaled LAS100977 in COPD patients - To assess the safety and tolerability of the LAS100977 doses in the same target population. - To assess the pharmacokinetics of LAS100977 in a sub-set of study patients;Secondary Objective: ;Primary end point(s): Change from baseline to through FEV1 on Day 2.;Timepoint(s) of evaluation of this end point: Please refer to E 5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change from baseline in normalised FEV1 and FVC AUC0-12, AUC0-24, AUC12-24 2) Change from baseline in FEV1 and FVC at each scheduled time point 3) Change from baseline in IC at each scheduled time point 4) Change from baseline to the peak FEV1 and FVC;Timepoint(s) of evaluation of this end point: 1) Day 1 2) Day 1 and 2 3) Day 1 and 2 4) Day 1 | — |
Countries
Germany
Contacts
Public ContactHelena Pujol Clinical Trial Manager
Almirall S.A.
Outcome results
None listed