- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03250689
Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD)
February 26, 2021 updated by: GlaxoSmithKline
Randomized Double Blind (Sponsor Unblind) Study Evaluating the Effect of 14 Days of Treatment With Danirixin (GSK1325756) on Neutrophil Extracellular Traps (NETs) Formation in Participants With Stable Chronic Obstructive Pulmonary Disease (COPD)
The inflammation associated with COPD is characterized by a prominent infiltration of neutrophils in lung tissue and airways.
The CXC chemokine receptor type 2 (CXCR2) plays a pivotal role in neutrophil recruitment to the lungs resulting in progressive fibrosis, airway stenosis, and destruction of the lung parenchyma characteristic of COPD.
There is a paucity of novel therapies that target these symptoms, and there are no currently available therapies that modify disease progression in COPD.
Danirixin (GSK1325756) is a selective CXCR2 antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD and influenza.
This study is a mechanistic study which aims to evaluate the effect of danirixin in reducing neutrophil extracellular traps (NETs) formation (or NETosis).
Subjects will be randomized (3:1) to receive danirixin hydrobromide (HBr) 35 milligram (mg) orally twice daily or matching placebo for 14 days.
Subjects may continue to use rescue medication(s) and inhaled COPD maintenance medication(s) during the study.
The study will consist of a screening period of up to 30 days, a 2 week treatment period, and a 1-week follow-up visit via phone call.
Approximately 50 subjects will be screened to obtain approximately 24 subjects to complete the study.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dundee, United Kingdom, DD1 9SY
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject must be 50 to 75 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of COPD with mild to moderate airflow obstruction FEV1/FVC ratio <0.7 and FEV1% predicted (pred) >=40% at screening) based on the Quanjer reference equations, with spirometry conducted according to American Thoracic Society (ATS)/European Respiratory Society (ERS) current guidelines.
- Elevated sputum neutrophil extracellular traps based on screening assay for histone-elastase complexes of >0.5 units/ milliliter (mL) sputum. Two further screening samples can be submitted for analysis within 30 day screening period if previous samples do not pass criteria.
- Able to produce at least 1 mL of sputum sample at the screening visit with nebulized saline induction.
- Current smokers and former smokers with a cigarette smoking history of >=10 pack years (1 pack year=20 cigarettes smoked per day for 1 year or equivalent). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- Body weight >=45 kilogram (kg).
- Male or female.
- A male subject must agree to use contraception during the treatment period and for at least [60 hours, corresponding to approximately 6 half-lives (which is the time needed to eliminate any teratogenic treatments after the last dose of study treatment and refrain from donating sperm during this period.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 60 hours after the last dose of study treatment.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
- Primary clinical diagnoses of any of the following relevant lung diseases; asthma, sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis or lung cancer.
- Known alpha-1-antitrypsin deficiency.
- Pulse oximetry <88% at rest at screening. Subjects should be tested while breathing room air.
- Subjects on long term oxygen therapy (defined as >15 hours/day of oxygen use).
- Unstable co-morbidities (e.g. cardiovascular disease, active malignancy) which in the opinion of the Investigator would make the subject unsuitable to be enrolled in the study. This includes any abnormality identified on screening bloods or screening ECG which in the opinion of the Investigator would make the subject unsuitable for the study.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator of GSK medical monitor, contraindicates their participation.
- Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
- Antibiotic use concurrently or within 28 days preceding the screening visit, including current or planned chronic use of macrolide antibiotics during the study period for the prevention of COPD exacerbations. Examples of chronic use include daily or two-three times per week for at least 3 months.
- Systemic immunosuppressive medication, including current oral corticosteroids at a dose >5 milligram (mg), concurrently or within 28 days preceding the screening visit.
- Oral or injectable Cytochrome P450 (CYP) 3A4 or Breast Cancer Resistance Protein (BCRP) substrates with narrow therapeutic index (CYP3A4 substrates include, but are not limited to, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, and theophylline; BCRP substrates include: Methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan.
- Current use of phosphodiesterase-4 inhibitors: Roflumilast, Crisaborole and Apremilast.
- Current use of Raloxifene.
- Current use of low molecular weight heparin.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four investigational products within 12 months prior to the first dosing day.
- Subjects with a peripheral blood neutrophil count < 1.0x10^9/liter (L) at screening.
- Diagnosis of pneumonia (chest X-ray or computed tomography [CT] confirmed) within the 3 months prior to screening.
- Chest X-ray (posterior with lateral) or CT scan reveals evidence of a clinically significant abnormality not believed to be due to the presence of COPD (historic data up to 1 year may be used).
- Abnormal and clinically significant 12-lead ECG finding at screening. The investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
- AF with rapid ventricular rate > 120 beats per minute (bpm);
- Sustained or non-sustained ventricular tachycardia (VT);
- Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator has been implanted);
- QT interval corrected for heart rate by Fridericia's formula (QTcF) >=500 millisecond (msec) in subjects with QRS <120 msec and QTcF >=530 msec in subjects with QRS >=120 msec.
- Affiliation with a study site: study investigators, sub-investigators, study coordinators, employees of a study investigator, sub-investigator or study site, or immediate family members of any of the above that is involved with the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Danirixin 35 mg
Eligible subjects will receive danirixin 35 mg tablet with food twice daily for 14 Days.
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Danirixin will be available as 35 mg oval shaped, white film coated HBr embossed tablets.
Subjects may continue to use rescue medication(s) anytime during the study.
The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
Subjects may continue to use inhaled COPD maintenance medication(s) during the study, at the discretion of the GSK Medical Monitor and/or Investigator.
The following maintenance medications may be used: long acting bronchodilator medications (e.g.
long-acting muscarinic antagonist [LAMA], long-acting beta-agonist [LABA]) and long-acting bronchodilator combination therapies (e.g.
LAMA/LABA) and long-acting bronchodilator/inhaled corticosteroid steroid combination (ICS) therapies (e.g.
LABA/ICS, LAMA/LABA/ICS)
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Experimental: Placebo Comparator
Eligible subjects will receive placebo tablet with food twice daily for 14 Days.
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Subjects may continue to use rescue medication(s) anytime during the study.
The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
Subjects may continue to use inhaled COPD maintenance medication(s) during the study, at the discretion of the GSK Medical Monitor and/or Investigator.
The following maintenance medications may be used: long acting bronchodilator medications (e.g.
long-acting muscarinic antagonist [LAMA], long-acting beta-agonist [LABA]) and long-acting bronchodilator combination therapies (e.g.
LAMA/LABA) and long-acting bronchodilator/inhaled corticosteroid steroid combination (ICS) therapies (e.g.
LABA/ICS, LAMA/LABA/ICS)
Placebo will be available as oval shaped, white film coated tablets.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in Sputum Neutrophil Extracellular Traps (NETs) Quantified by Histone-Elastase Complexes
Time Frame: Baseline (Day 1), Day 7 and Day 14
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Sputum samples were collected at indicated time points to assess NET formation via histone elastase complexes.
Baseline was considered as Day 1.
If Day 1 values were missing, screening value was imputed for Baseline.
Change from Baseline was calculated as post-Baseline value minus Baseline value.
Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by 100.
Analysis was performed using a mixed effect repeated measures model with covariates of treatment group, log(Baseline NETs) and treatment group by day interaction.
The response variable was the log of the ratio of post-Baseline NETs to Baseline NETs.
Primary completer population consisted of all participants in the Modified Intent-To-Treat population who had completed the assessments supporting the primary endpoint (sputum NETs).
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Baseline (Day 1), Day 7 and Day 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Sputum NETs Quantified by Deoxyribonucleic Acid (DNA)-Elastase Complexes
Time Frame: Baseline (Day 1), Day 7 and Day 14
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Sputum samples were collected at indicated time points to assess NET formation via DNA elastase complexes.
Baseline was considered as Day 1.
If Day 1 values were missing, screening value was imputed for Baseline.
Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1), Day 7 and Day 14
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Change From Baseline in Percentage of Microscope Field Area Occupied by Sputum NETs
Time Frame: Baseline (Day 1), Day 7 and Day 14
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Sputum samples were collected at indicated time points and NETs area was quantified by microscopy.
Baseline was considered as Day 1.
If Day 1 values were missing, screening value was imputed for Baseline.
Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1), Day 7 and Day 14
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Day 21
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
A SAE is defined as any untoward medical occurrence that, at any dose results in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes, Modified Intent-to-Treat Population consisted of all randomized participants who received at least one dose of study treatment.
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Up to Day 21
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time Frame: Baseline (Day 1), Day 7 and Day 14
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SBP and DBP were measured in seated position after 5 minutes rest for the participants at indicated time points.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1), Day 7 and Day 14
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Change From Baseline in Heart Rate
Time Frame: Baseline (Day 1), Day 7 and Day 14
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Heart rate was measured in seated position after 5 minutes rest for the participants at indicated time points.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1), Day 7 and Day 14
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Change From Baseline in Respiration Rate
Time Frame: Baseline (Day 1), Day 7 and Day 14
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Respiration rate was measured in seated position after 5 minutes rest for the participants at indicated time points.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1), Day 7 and Day 14
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Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
Time Frame: Baseline (Day 1) and Day 14
|
Triplicate 12-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Spirometry: Forced Expiratory Volume in One Second (FEV1) at Indicated Time Points
Time Frame: Day 1 and Day 14
|
FEV1 is the amount of air that can be forcefully exhaled from the lungs in the first second of a forced exhalation.
It was measured by spirometry test.
Mean and standard deviation data of FEV1 measured at Day 1 and Day 14 have been presented.
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Day 1 and Day 14
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Spirometry: Forced Vital Capacity (FVC) at Indicated Time Points
Time Frame: Day 1 and Day 14
|
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
It was measured by spirometry test.
Mean and standard deviation data of FVC measured at Day 1 and Day 14 have been presented.
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Day 1 and Day 14
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Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
Time Frame: Baseline (Day 1) and Day 14
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Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets counts, Total neutrophils and WBC count.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Hematology Parameter: Hematocrit
Time Frame: Baseline (Day 1) and Day 14
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Blood samples were collected to analyze the hematology parameter: Hematocrit.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Hematology Parameter: Hemoglobin
Time Frame: Baseline (Day 1) and Day 14
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Blood samples were collected to analyze the hematology parameter: Hemoglobin.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Hematology Parameter: Mean Corpuscular Volume
Time Frame: Baseline (Day 1) and Day 14
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Blood samples were collected to analyze the hematology parameter: Mean Corpuscular Volume.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Time Frame: Baseline (Day 1) and Day 14
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Blood samples were collected to analyze the hematology parameter: Mean Corpuscular Hemoglobin.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Hematology Parameter: Red Blood Cell Count
Time Frame: Baseline (Day 1) and Day 14
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Blood samples were collected to analyze the hematology parameter: Red Blood Cell count.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)
Time Frame: Baseline (Day 1) and Day 14
|
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Time Frame: Baseline (Day 1) and Day 14
|
Blood samples were collected to analyze the chemistry parameters: Calcium, Glucose, Potassium, Sodium and Urea.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin
Time Frame: Baseline (Day 1) and Day 14
|
Blood samples were collected to analyze the chemistry parameters: Creatinine, Direct Bilirubin and Total Bilirubin.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Urinalysis Parameter: Specific Gravity
Time Frame: Baseline (Day 1) and Day 14
|
Urinary specific gravity measurement is a part of routine urinalysis.
Urine specific gravity is a measure of the concentration of solutes in the urine.
It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.
The concentration of the excreted molecules determines the urine's specific gravity.
Urine samples were collected from participants at indicated time points for analysis of specific gravity.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)
Time Frame: Baseline (Day 1) and Day 14
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Urine samples were collected from participants at indicated time points for analysis of pH.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Change From Baseline in Sputum Resistin Levels
Time Frame: Baseline (Day 1), Day 7 and Day 14
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Sputum samples were collected at indicated time points to analyze resistin levels.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
|
Baseline (Day 1), Day 7 and Day 14
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Change From Baseline in the Ratio of Sputum NETs to Sputum Neutrophils
Time Frame: Baseline (Day 1) and Day 14
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Sputum samples were collected to calculate ratio of sputum NETs to sputum neutrophils.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
The ratio is calculated as the sputum NETs divided by the number of sputum neutrophils.
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Baseline (Day 1) and Day 14
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Change From Baseline in Sputum Elastase Activity
Time Frame: Baseline (Day 1), Day 7 and Day 14
|
Sputum samples were collected at indicated time points to analyze sputum elastase activity.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
|
Baseline (Day 1), Day 7 and Day 14
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Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by DNA Release
Time Frame: Baseline (Day 1) and Day 14
|
Blood samples were collected at indicated time points to analyze peripheral blood neutrophil NETs formation by DNA release.
DNA-elastase complexes quantified NETs formation.
Phorbol 12-myristate 13-acetate (PMA) was used to induce inflammation and NETs formation in the PMA stimulated samples.
Blood from participants were tested at Baseline and Day 14 for non-PMA stimulated samples, and at Baseline and Day 14 in PMA-stimulated samples to test whether treatment had any effect on NETs formation either naturally (non PMA induced) or where NETs formation was already raised (PMA stimulated).
Hence participants were counted in both the categories - PMA stimulated and not PMA stimulated.
NETs formation in peripheral blood was measured with SYTOX green fluorescence quantification of extracellular DNA.
Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
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Baseline (Day 1) and Day 14
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Percentage Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by Microscopy
Time Frame: Baseline (Day 1) and Day 14
|
Blood samples were collected at indicated time points to analyze peripheral blood neutrophil NETs formation by microscopy.DNA-elastase complexes quantified NETs formation.PMA was used to induce inflammation and NETs formation in PMA stimulated samples.
Blood from participants were tested at Baseline and Day14 for non-PMA stimulated samples,and at Baseline and Day14 in PMA-stimulated samples to test whether treatment had any effect on NETs formation either naturally(non PMA induced)or where NETs formation was already raised(PMA stimulated).Participants were counted in both categories-PMA stimulated and not PMA stimulated.NETs formation in peripheral blood was measured with SYTOX green fluorescence quantification of extracellular DNA.Baseline was considered as Day1.Change from Baseline was calculated as post-Baseline value minus Baseline value.Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by100.
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Baseline (Day 1) and Day 14
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Maximum Observed Concentration (Cmax) of Danirixin
Time Frame: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
|
Blood samples were collected to evaluate the pharmacokinetic (PK) of danirixin at the indicated time points for the analysis of Cmax.
PK population consisted of all participants in the Modified Intent-To-Treat population who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values).
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Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
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Time to Cmax (Tmax) of Danirixin
Time Frame: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
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Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tmax.
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Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
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Area Under the Blood Concentration-time Curve [AUC(0-t)] of Danirixin
Time Frame: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
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Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of AUC(0-t).
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Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
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Time of Last Observed Concentration (Tlast) of Danirixin
Time Frame: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
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Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tlast.
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Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2017
Primary Completion (Actual)
October 8, 2018
Study Completion (Actual)
October 8, 2018
Study Registration Dates
First Submitted
August 11, 2017
First Submitted That Met QC Criteria
August 11, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2021
Last Update Submitted That Met QC Criteria
February 26, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 207551
- 2017-001069-25 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
IPD for this study is available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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