Chronic obstructive pulmonary disease MedDRA version: 19.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Danirixin
Product Code: GSK1325756H
Pharmaceutical Form: Tablet
INN or Proposed INN: Danirixin
Current Sponsor code: GSK1325756H
Other descriptive name: GSK1325756H
Concentration unit: m
Sponsors
GlaxoSmithKline, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 40 to 80 years of age inclusive, at the time of signing the informed consent. 2. Participants who have COPD (postbronchodilator FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other clinically relevant lung diseases (other than COPD), e.g. sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis or lung cancer. 2. Alpha-1-antitrypsin deficiency as the underlying cause of COPD 3. Pulse oximetry 120 bpm b. sustained or non-sustained VT c. second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator has been implanted) d. QTcF =500 msec in participants with QRS < 120 msec and QTcF =530 msec in participants with QRS =120 msec 11. Previous lung surgery (e.g. lobectomy, pneumonectomy) or lung volume reduction procedure. 12. Current or expected chronic use of macrolide antibiotics during the study period for the prevention of COPD exacerbations. Examples of chronic use include, but are not limited to, daily or two to three times per week use for at least 3 months. 13. Oral or injectable CYP3A4 or BRCP (breast cancer resistance protein) substrates with a narrow therapeutic index (CYP3A4 substrates include, but are not limited to, alfenatil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, and theophylline; BCRP substrates include, but are not limited to, topotecan.) The Investigator should consult with the Medical Monitor if necessary. 14. Current or e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To characterize the dose response of danirixin compared with placebo on the incidence and severity of respiratory symptoms in participants with COPD - To compare the safety of danirixin with placebo in participants with COPD;Secondary Objective: - To characterize the dose response of danirixin compared with placebo on the annual rate of moderate/severe COPD exacerbations in participants with COPD - To further characterize the clinical activity of danirixin compared to placebo in participants with COPD - To characterize the pharmacokinetics of danirixin in participants with COPD.;Primary end point(s): - Change from baseline in respiratory symptoms measured by E-RS:COPD daily diary: total score and subscales (i.e. breathlessness, cough and sputum, and chest symptoms) - Adverse events (AE), clinical laboratory values, vital signs, electrocardiogram (ECG).;Timepoint(s) of evaluation of this end point: - E-RS: COPD at week 24 - Safety parameters – ongoing throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Healthcare Resource Utilization (HCRU)-defined COPD exacerbations - E-RS:COPD Responder Analysis (including subscales) - Number of Exacerbations of Chronic Pulmonary Disease (EXACT) tool defined events - Time to first EXACT event - EXACT event severity - EXACT event duration for all events - Time to first HCRU-defined COPD exacerbation - Time to first severe HCRU-defined COPD exacerbation - HCRU-defined exacerbation duration - Change from baseline for the St. George’s Respiratory Questionnaire (SGRQ) total score (derived from SGRQ-C) - SGRQ responder analysis - Change for baseline COPD Assessment Test (CAT) total score - CAT responder analysis - Lung function (FEV1, FEV1 % predicted, FVC, FEV1/FVC ratio) - Rescue medication use - Participant experience of physical activity (subset of approximately 50% of participants) measured using PROactive Clinic Visit Tool (C-PPAC) - Danirixin concentration and standard pharmacokinetic parameters for danirixin (e.g. AUC, Cmax, Tmax), using dried blood spot data.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Australia, Canada, Germany, Korea, Republic of, Netherlands, Poland, Spain, United States
Contacts
Public ContactCentro de Información
GlaxoSmithKline
Outcome results
None listed