NL-OMON45435CompletedPhase 2
Randomised, Double-Blind(Sponsor Open), Placebo-Controlled, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of Danirixin Tablets Administered Twice Daily Compared With Placebo for 24Weeks in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD) (study 205724) - 205724
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •* 40 to 80years of age inclusive.
- •* COPD based on ATS/ERS current guidelines.
- •* Symptoms including chronic cough, mucus hypersecretion, and dyspnea on most days for at least the previous 3 months.
- •* Documented history of COPD exacerbation(s) in the previous year. See protocol page 28 for details.
- •* Current and former smokers with a cigarette smoking history of *10 pack years. See protocol page 28 for details.
- •* Female participant of childbearing potential and male participant who agrees to follow the contraceptive guidance in appendix5 of the protocol during the treatment period and for at least 60 hours after the last dose of study treatment.
Exclusion Criteria
- •* Diagnosis of other clinically relevant lung diseases (other than COPD).
- •* Alpha-1-antitrypsin deficiency.
- •* Less than 14 days have elapsed from the completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation.
- •* Peripheral blood neutrophil count <1.5 x 109/L.
- •* Pneumonia (chest X-ray or CT confirmed) within the 3 months prior to screening.
- •* Chest x-ray or CT scan with evidence of a clinically significant abnormality not believed to be due to the presence of COPD (historic results up to 1 year prior to screening may be used).
- •* Current or chronic history of liver disease, or known hepatic or biliary abnormalities. Exceptions see protocol page 30.
- •* Abnormal and clinically significant 12-lead ECG finding. See protocol page 30 for details.
- •* Prior/Concomitant Therapy: see protocol page 30 for details.
- •* Prior/Concurrent Clinical Study Experience: see protocol page 31 for details.
- •* Pregnancy or breastfeeding.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A study to test different doses of Danirixin in patients with COPDChronic obstructive pulmonary diseaseMedDRA version: 20.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2016-003675-21-PLGlaxoSmithKline Research & Development Ltd600
Active, not recruiting
Phase 1
A study to test different doses of Danirixin in patients with COPDEUCTR2016-003675-21-ESGlaxoSmithKline, S.A.600
Active, not recruiting
Phase 1
A study to test different doses of Danirixin in patients with COPDChronic obstructive pulmonary diseaseMedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855EUCTR2016-003675-21-DEGlaxoSmithKline Research & Development Ltd614
Active, not recruiting
Phase 1
A study to test different doses of Danirixin in patients with COPDEUCTR2016-003675-21-NLGlaxoSmithKline Research & Development Ltd600
Completed
Not Applicable
Randomised, Double-Blind, Placebo Controlled, Cross Over Trial of a Parenteral Modified Cobratoxin in AdrenomyeloneuropathyISRCTN48334111ReceptoPharm Inc. (USA)