None listed
Conditions
Interventions
2.5 mg L-000883191 Type of group
2.5 mg of L-000883191 once a day + usual treatment
Group name:Usual treatment
Type of group
Inhaled beta-agonists [either immediate or long-acting], inhaled corticosteroids or anticholinergics [either immediate or prolonged action] are administered, in accordance with the usual clinical practice of the investigator
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: to. The patient has successfully completed the schedule until Visit 20 of Protocol 005-21, inclusive. b. The patient understands the study procedures and agrees to participate in the study by providing written informed consent.
Exclusion criteria
Exclusion criteria: a. In the 2 consecutive weeks immediately prior to the first visit of In this extension, the patient had some serious clinical or laboratory adverse event, related to the drug, during his participation in Protocol 005-21, which, according to the medical criteria of the investigators, would exclude the patient from participating or concluding the study. . b. The patient has significant changes in his general medical condition since his enrollment in Protocol 005-21, which, according to the medical criteria of the investigators, would exclude the patient from participating or concluding the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical monitoring (vital signs, physical exams, pulmonary function tests and Hemoccult tests) and monitoring of clinical and laboratory adverse events. Measure:Collect additional long-term safety and tolerability data on 2.5 mg of L-000883191 administered once a day. Timepoints:13 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:FEV1 and FVC Predosis, FEV1 and EVO Post p-agonist, St. Georges Respiratory Questionnaire (SGRQ) and EuroQOL Questionnaire will be measured for informal exploratory efficacy and safety purposes. Measure:Measuring the effectiveness of L-000883191 Timepoints:13 week | — |
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed