A Phase 1 interventional study of [14C]-GSK2269557 IV infusion and GSK2269557 via DPI in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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Among 10 studies testing nemiralisib in Pulmonary Disease, Chronic Obstructive — none open to participants now, none under way, none of them phase 3. Nemiralisib · Pulmonary Disease, Chronic Obstructive.
Among the 10 studies testing nemiralisib in Pulmonary Disease, Chronic Obstructive, this one is the 10th largest by enrollment, is one of 2 that started in 2017, is one of 6 in phase 1, and was the 9th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →None of the 10 studies testing nemiralisib in Pulmonary Disease, Chronic Obstructive is open now. The open studies under Pulmonary Disease, Chronic Obstructive, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 30 Years to 55 Years · male · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 40 across the 10 interventional studies. Of the 10 that completed or were terminated, 7 (70%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 10 have an industry lead sponsor. The 1 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline: 7 open now, 8 under way, 5 of them phase 3. Of 264 finished, 141 (53%) have results posted.
Among the 276 studies in Pulmonary Disease, Chronic Obstructive by GlaxoSmithKline, this one is the 228th largest by enrollment of the 236 interventional ones that give a count, is one of 18 that started in 2017, is one of 83 in phase 1, and was the 240th registered.
GlaxoSmithKline’s Pulmonary Disease, Chronic Obstructive studies by the year they started, since 2000.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing nemiralisib in Pulmonary Disease, Chronic Obstructive, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 276 in Pulmonary Disease, Chronic Obstructive:
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GSK2269557 is being developed as an anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases such as asthma. This study is designed to investigate the recovery, excretion, and pharmacokinetics (PK) of (14 Carbon [C])-GSK2269557 administered as a single intravenous (IV) dose (concomitant with an inhaled non-radiolabelled dose) and as a single oral dose in 6 healthy male subjects. Subjects will receive [14C] radiolabelled GSK2269557 administered as IV infusion, with a nonradiolabelled dose of GSK2269557 via dry powder inhaler (DPI) in treatment period 1 and a single dose of [14C]-GSK2269557, administered as an oral solution in treatment period 2. There will be a washout period of at least 14 days after inhaled and IV dosing before subjects takes part in treatment period 2. The IV microtracer dose of GSK2269557 will be administered concomitant to an inhaled non-radiolabelled dose to ensure that the pharmacokinetics represent a clinically relevant dose. The total study duration will be up to 11 weeks, including a screening visit, 2 treatment periods and a follow-up visit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive IV infusion of \[14C\] radiolabelled GSK2269557 with a single dose of 10 micrograms (µg) administered as single microtracer, concomitantly with an inhaled nonradiolabelled 1000 µg dose of GSK2269557. There will be a washout of at least 14 days after inhaled and IV dosing before subjects receive treatment 2.
Drug: [14C]-GSK2269557 IV infusion · Drug: GSK2269557 via DPI · Drug: [14C]-GSK2269557 oral solution
Eligible subjects will receive \[14C\]-GSK2269557 with a single dose of 800 µg, administered as an oral solution.
Drug: [14C]-GSK2269557 IV infusion · Drug: GSK2269557 via DPI · Drug: [14C]-GSK2269557 oral solution
The \[14C\]-GSK2269557 solution will be available in dosing strength of 10 µg, administered as single dose IV infusion over 15 minutes. It will be prepared by dissolving a hemisuccinate salt (GSK2269557T) in normal saline.
GSK2269557 DPI will be available with dosing strength of 1000 µg, administered as oral inhalation intended to inhale twice. It will be prepared by blending GSK2269557 hemisuccinate salt (GSK2269557H) with lactose and magnesium stearate.
The \[14C\]-GSK2269557 solution will be available with dosing strength of 800 µg, administered as single dose orally. It will be prepared by dissolving \[14C\]-GSK2269557 hemisuccinate salt (GSK2269557T) in water.
Area Under Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Infinite Time (0 to Inf) and AUC From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (0 to t) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic (PK) Population comprised of participants in the APE Population who received at least one dose of study treatment and for whom a PK sample was obtained and analyzed. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (0 to Inf) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (0 to t) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis. Only those participants available at the specified time points were analyzed represented by n=X in the category titles. NA indicates that data is not available as single participant was analyzed.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Maximum Observed Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Cmax of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Tmax of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis. NA indicates that data is not available as single participant was analyzed.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Urinary and Faecal Cumulative Excretion as a Percentage of the Total Radioactive Dose Administered Over Time for Treatment Period 1
Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively.
Time frame: Up to 168 hours
Urinary and Fecal Cumulative Excretion as a Percentage of the Total Radioactive Dose Administered Over Time for Treatment Period 2
Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Time frame: Up to 336 hours
AUC (0 to Inf) and AUC (0 to t) of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
AUC (0 to Inf) and AUC (0 to t) of [14C]-GSK2269557 in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Cmax of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Cmax of [14C]-GSK2269557 in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Tmax of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Tmax of [14C]-GSK2269557 in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
t1/2 of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS. Only those participants available at the indicated time points were analyzed represented by n=X in the category titles.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
t1/2 of [14C]-GSK2269557 in Plasma for Treatment Period 2
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Volume of Distribution of Parent [14C]-GSK2269557 After IV Dose Only in Plasma
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Clearance of Parent [14C]-GSK2269557 After IV Dose Only in Plasma
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Inhaled Absolute Bioavailability (F) for Treatment Period 1
Absolute bioavailability (F) was estimated for the inhaled doses for each participant and is reported. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Time frame: Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion
Oral Absolute Bioavailability (F) for Treatment Period 2
Absolute bioavailability (F) was estimated for the oral doses for each participant and is reported. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia.
Time frame: Up to 11 weeks
Number of Participants With Hematology Parameters of Potential Clinical Concern
Hematology parameters included basophils, eosinophils, erythrocytes, monocytes, hematocrit, hemoglobin, lymphocytes, neutrophil count, platelet count and white blood cells. Number of participants with hematology parameters of potential clinical concern are presented.
Time frame: Up to 11 weeks
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern
Clinical chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, chloride, cholesterol, gamma glutamyl transferase, globulin, protein, triglycerides, urate, albumin, calcium, creatinine, glucose, phosphorous, potassium, urea and sodium. Number of participants with clinical chemistry parameters of potential clinical concern are presented.
Time frame: Up to 11 weeks
Number of Participants With Clinically Significant Urinalysis Findings
Urine samples were collected to detect the presence of bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, protein and urobilinogen. Urinalysis also included measurement of specific gravity and pH. Number of participants with clinically significant urinalysis findings are presented.
Time frame: Up to 168 hours
Number of Participants With Electrocardiogram Findings of Clinical Significance
Twelve-lead electrocardiogram was measured in a supine or semi-supine position after 5 minutes rest. Number of participants with electrocardiogram findings of clinical significance are presented.
Time frame: Up to 11 weeks
Number of Participants With Vital Signs of Potential Clinical Concern
Vital signs were measured in a supine or semi-supine position after 5 minutes rest and included temperature, systolic and diastolic blood pressure and pulse and respiratory rate. Number of participants with vital signs of potential clinical concern are reported.
Time frame: Up to 11 weeks
The study was conducted at a single center in the United Kingdom from 14-November-2017 to 22-December-2017.
| Milestone | All Study Participants |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
| Milestone | All Study Participants |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
| Milestone | All Study Participants |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic (PK) Population comprised of participants in the APE Population who received at least one dose of study treatment and for whom a PK sample was obtained and analyzed. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Hour*picogram Equivalent per millilitre | Nemi IH + 14C-Nemi IV |
|---|---|
| AUC (0 to inf), n=3 | 812.8550 ± 8.17885 |
| AUC (0 to t), n=6 | 770.3316 ± 17.70272 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. Only those participants available at the specified time points were analyzed represented by n=X in the category titles. NA indicates that data is not available as single participant was analyzed.
| Hour*picogram Equivalent per millilitre | 14C-Nemi Oral |
|---|---|
| AUC (0 to inf), n=1 | 34749.40 ± NA |
| AUC (0 to t), n=6 | 31730.13 ± 35.715 |
Blood samples were collected at indicated time points for pharmacokinetic analysis.
| Picogram Equivalent per milliliter | Nemi IH + 14C-Nemi IV |
|---|---|
| Maximum Observed Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1 | 204.4057 ± 52.32698 |
Blood samples were collected at indicated time points for pharmacokinetic analysis.
| Picogram Equivalent per milliliter | 14C-Nemi Oral |
|---|---|
| Cmax of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2 | 703.5192 ± 24.43331 |
Blood samples were collected at indicated time points for pharmacokinetic analysis.
| Hours | Nemi IH + 14C-Nemi IV |
|---|---|
| Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1 | 0.2333 (0.2333 to 0.2333) |
Blood samples were collected at indicated time points for pharmacokinetic analysis.
| Hours | 14C-Nemi Oral |
|---|---|
| Tmax of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2 | 7.0000 (2.000 to 8.017) |
Blood samples were collected at indicated time points for pharmacokinetic analysis.
| Hours | Nemi IH + 14C-Nemi IV |
|---|---|
| Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1 | 56.9152 ± 7.69827 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. NA indicates that data is not available as single participant was analyzed.
| Hours | 14C-Nemi Oral |
|---|---|
| Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2 | 39.6279 ± NA |
Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively.
| Percentage of dose excreted | Nemi IH + 14C-Nemi IV |
|---|---|
| Fe Feces, 0 to 24 hour | 0.3961 ± 0.83271 |
| Fe Feces, 24 to 48 hour | 2.1998 ± 3.77158 |
| Fe Feces, 48 to 72 hour | 18.1265 ± 12.97670 |
| Fe Feces, 72 to 96 hour | 28.0481 ± 18.22334 |
| Fe Feces, 96 to 120 hour | 33.7465 ± 19.02044 |
| Fe Feces, 120 to 144 hour | 45.2398 ± 14.63248 |
| Fe Feces, 144 to 168 hour | 51.6981 ± 15.46780 |
| Fe Urine, 0 to 6 hour | 2.1567 ± 0.83754 |
| Fe Urine, 6 to 24 hour | 5.1183 ± 1.53825 |
| Fe Urine, 24 to 48 hour | 7.6850 ± 2.04159 |
| Fe Urine, 48 to 72 hour | 9.3483 ± 2.26387 |
| Fe Urine, 72 to 96 hour | 10.7150 ± 2.46640 |
| Fe Urine, 96 to 120 hour | 11.6400 ± 2.52790 |
| Fe Urine, 120 to 144 hour | 12.3607 ± 2.56693 |
| Fe Urine, 144 to 168 hour | 12.9205 ± 2.57056 |
| Fe Total (Urine+Feces), 0 to 24 hour | 5.5145 ± 1.30554 |
| Fe Total (Urine+Feces), 24 to 48 hour | 9.8848 ± 3.03062 |
| Fe Total (Urine+Feces), 48 to 72 hour | 27.4748 ± 13.02973 |
| Fe Total (Urine+Feces), 72 to 96 hour | 38.7631 ± 18.40877 |
| Fe Total (Urine+Feces), 96 to 120 hour | 45.3865 ± 19.01459 |
| Fe Total (Urine+Feces), 120 to 144 hour | 57.6005 ± 14.46954 |
| Fe Total (Urine+Feces), 144 to 168 hour | 64.6186 ± 15.25339 |
Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Percentage of dose excreted | 14C-Nemi Oral |
|---|---|
| Fe Feces, 0 to 24 hour; n=6 | 3.81330 ± 7.16484 |
| Fe Feces, 24 to 48 hour; n=6 | 14.6367 ± 21.64607 |
| Fe Feces, 48 to 72 hour; n=6 | 40.9583 ± 28.48392 |
| Fe Feces, 72 to 96 hour; n=6 | 48.8217 ± 29.60581 |
| Fe Feces, 96 to 120 hour; n=6 | 60.7617 ± 18.24192 |
| Fe Feces, 120 to 144 hour; n=6 | 64.1667 ± 19.65337 |
| Fe Feces, 144 to 168 hour; n=6 | 72.4217 ± 6.66365 |
| Fe Feces, 168 to 192 hour; n=6 | 75.1117 ± 5.29605 |
| Fe Feces, 192 to 216 hour; n=6 | 77.0917 ± 4.59090 |
| Fe Feces, 216 to 240 hour; n=6 | 77.5933 ± 4.12513 |
| Fe Feces, 240 to 264 hour; n=6 | 78.7917 ± 3.82906 |
| Fe Feces, 264 to 288 hour; n=5 | 78.6820 ± 4.07492 |
| Fe Feces, 288 to 312 hour; n=3 | 80.9500 ± 3.78747 |
| Fe Feces, 312 to 336 hour; n=3 | 81.1500 ± 3.57979 |
| Fe Urine, 0 to 6 hour; n=6 | 0.3867 ± 0.09668 |
| Fe Urine, 6 to 24 hour; n=6 | 1.7017 ± 0.42995 |
| Fe Urine, 24 to 48 hour; n=6 | 2.7183 ± 0.73249 |
| Fe Urine, 48 to 72 hour; n=6 | 3.4250 ± 0.89063 |
| Fe Urine, 72 to 96 hour; n=6 | 3.9600 ± 0.97980 |
| Fe Urine, 96 to 120 hour; n=6 | 4.3617 ± 1.02918 |
| Fe Urine, 120 to 144 hour; n=6 | 4.6717 ± 1.09549 |
| Fe Urine, 144 to 168 hour; n=6 | 4.9217 ± 1.12583 |
| Fe Urine, 168 to 192 hour; n=6 | 5.1383 ± 1.16426 |
| Fe Urine, 192 to 216 hour; n=6 | 5.2950 ± 1.16156 |
| Fe Urine, 216 to 240 hour; n=6 | 5.4700 ± 1.20854 |
| Fe Urine, 240 to 264 hour; n=6 | 5.5617 ± 1.24856 |
| Fe Urine, 264 to 288 hour; n=5 | 5.4760 ± 1.35858 |
| Fe Urine, 288 to 312 hour; n=3 | 5.7800 ± 1.43293 |
| Fe Urine, 312 to 336 hour; n=3 | 5.8133 ± 1.45590 |
| Fe Total (Urine+Feces), 0 to 24 hour; n=6 | 5.5150 ± 7.01205 |
| Fe Total (Urine+Feces), 24 to 48 hour; n=6 | 17.3550 ± 21.303 |
| Fe Total (Urine+Feces), 48 to 72 hour; n=6 | 44.3833 ± 28.28365 |
| Fe Total (Urine+Feces), 72 to 96 hour; n=6 | 52.7817 ± 29.36619 |
| Fe Total (Urine+Feces), 96 to 120 hour; n=6 | 65.1233 ± 17.8525 |
| Fe Total (Urine+Feces), 120 to 144 hour; n=6 | 68.8383 ± 19.24589 |
| Fe Total (Urine+Feces), 144 to 168 hour; n=6 | 77.3433 ± 6.27302 |
| Fe Total (Urine+Feces), 168 to 192 hour; n=6 | 80.2500 ± 4.74848 |
| Fe Total (Urine+Feces), 192 to 216 hour; n=6 | 82.3867 ± 3.98209 |
| Fe Total (Urine+Feces), 216 to 240 hour; n=6 | 83.0633 ± 3.3933 |
| Fe Total (Urine+Feces), 240 to 264 hour; n=6 | 84.3533 ± 3.17528 |
| Fe Total (Urine+Feces), 264 to 288 hour; n=5 | 84.158 ± 3.25412 |
| Fe Total (Urine+Feces), 288 to 312 hour; n=3 | 86.7300 ± 2.44851 |
| Fe Total (Urine+Feces), 312 to 336 hour; n=3 | 86.9633 ± 2.16207 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Hour*picogram per milliliter | Nemi IH + 14C-Nemi IV |
|---|---|
| GSK2269557: AUC (0 to inf), n=6 | 33374.56 ± 33.190 |
| GSK2269557: AUC (0 to t), n=6 | 28425.82 ± 34.474 |
| [14C]-GSK2269557: AUC (0 to inf), n=4 | 750.5798 ± 48.27760 |
| [14C]-GSK2269557: AUC (0 to t), n=6 | 546.4731 ± 45.31868 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
| Hour*picogram per milliliter | 14C-Nemi Oral |
|---|---|
| AUC (0 to inf), n=4 | 25107.96 ± 46.310 |
| AUC (0 to t), n=6 | 16913.06 ± 53.841 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS.
| Picograms per milliliter | Nemi IH + 14C-Nemi IV |
|---|---|
| GSK2269557 | 5258.98 ± 62.819 |
| [14C]-GSK2269557 | 205.6264 ± 57.91419 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
| Picograms per milliliter | 14C-Nemi Oral |
|---|---|
| Cmax of [14C]-GSK2269557 in Plasma for Treatment Period 2 | 398.8822 ± 27.81929 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS.
| Hours | Nemi IH + 14C-Nemi IV |
|---|---|
| GSK2269557 | 0.0333 (0.017 to 0.050) |
| [14C]-GSK2269557 | 0.2333 (0.2333 to 0.2333) |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
| Hours | 14C-Nemi Oral |
|---|---|
| Tmax of [14C]-GSK2269557 in Plasma for Treatment Period 2 | 6.0000 (2.000 to 8.000) |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS. Only those participants available at the indicated time points were analyzed represented by n=X in the category titles.
| Hours | Nemi IH + 14C-Nemi IV |
|---|---|
| GSK2269557 | 58.4408 ± 16.84150 |
| [14C]-GSK2269557 | 54.7223 ± 35.98970 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
| Hours | 14C-Nemi Oral |
|---|---|
| t1/2 of [14C]-GSK2269557 in Plasma for Treatment Period 2 | 50.8028 ± 40.16665 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
| Liters | Nemi IH + 14C-Nemi IV |
|---|---|
| Vss | 727.7102 ± 11.24581 |
| Vz | 851.4423 ± 13.98220 |
Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature \[14C\]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.
| Liters per hour | Nemi IH + 14C-Nemi IV |
|---|---|
| Clearance of Parent [14C]-GSK2269557 After IV Dose Only in Plasma | 10.7849 ± 46.70161 |
Absolute bioavailability (F) was estimated for the inhaled doses for each participant and is reported. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Fraction of drug | Nemi IH + 14C-Nemi IV |
|---|---|
| Inhaled F (0 to inf); n=4 | 0.3807 ± 19.65374 |
| Inhaled F (0 to t); n=6 | 0.4213 ± 21.84410 |
Absolute bioavailability (F) was estimated for the oral doses for each participant and is reported. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
| Fraction of drug | 14C-Nemi Oral |
|---|---|
| Oral F (0 to inf); n=4 | 0.3515 ± 3.35095 |
| Oral F (0 to t); n=6 | 0.3261 ± 12.77892 |
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia.
| Participants | Nemi IH + 14C-Nemi IV | 14C-Nemi Oral |
|---|---|---|
| AE | 0 | 1 |
| SAE | 0 | 0 |
Hematology parameters included basophils, eosinophils, erythrocytes, monocytes, hematocrit, hemoglobin, lymphocytes, neutrophil count, platelet count and white blood cells. Number of participants with hematology parameters of potential clinical concern are presented.
| Participants | Nemi IH + 14C-Nemi IV | 14C-Nemi Oral |
|---|---|---|
| Number of Participants With Hematology Parameters of Potential Clinical Concern | 2 | 1 |
Clinical chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, chloride, cholesterol, gamma glutamyl transferase, globulin, protein, triglycerides, urate, albumin, calcium, creatinine, glucose, phosphorous, potassium, urea and sodium. Number of participants with clinical chemistry parameters of potential clinical concern are presented.
| Participants | Nemi IH + 14C-Nemi IV | 14C-Nemi Oral |
|---|---|---|
| Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern | 0 | 0 |
Urine samples were collected to detect the presence of bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, protein and urobilinogen. Urinalysis also included measurement of specific gravity and pH. Number of participants with clinically significant urinalysis findings are presented.
| Participants | Nemi IH + 14C-Nemi IV | 14C-Nemi Oral |
|---|---|---|
| Number of Participants With Clinically Significant Urinalysis Findings | 0 | 0 |
Twelve-lead electrocardiogram was measured in a supine or semi-supine position after 5 minutes rest. Number of participants with electrocardiogram findings of clinical significance are presented.
| Participants | Nemi IH + 14C-Nemi IV | 14C-Nemi Oral |
|---|---|---|
| Number of Participants With Electrocardiogram Findings of Clinical Significance | 0 | 0 |
Vital signs were measured in a supine or semi-supine position after 5 minutes rest and included temperature, systolic and diastolic blood pressure and pulse and respiratory rate. Number of participants with vital signs of potential clinical concern are reported.
| Participants | Nemi IH + 14C-Nemi IV | 14C-Nemi Oral |
|---|---|---|
| High respiratory rate | 1 | 0 |
| Low temperature | 1 | 0 |
Collected over Serious and non serious adverse events were evaluated up to 11 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nemi IH + 14C-Nemi IV | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| 14C-Nemi Oral | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Event | Nemi IH + 14C-Nemi IV | 14C-Nemi Oral |
|---|---|---|
| MalaiseGeneral disorders | 0/6 | 1/6 |
| HeadacheNervous system disorders | 0/6 | 1/6 |
| Age, Continuous(Years) | All Study Participants |
|---|---|
| Mean | 43.3 ± 10.03 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 0 |
| Male | 6 |
| Race/Ethnicity, Customized(Count of participants) | All Study Participants |
|---|---|
| African American/African Heritage | 2 |
| White - White/Caucasian/European Heritage | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Nov 2017 to primary completion in Dec 2017, 1 month.
Results were first posted in Mar 2019, 1 year 2 months after primary completion.
Of 158 industry-sponsored phase 1 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's 1 month is below that.
Counting every sponsor, half of 176 studies reached it within 4 months; a quarter within 2 and three quarters within 11.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nemiralisib
Pulmonary Disease, Chronic Obstructive →