Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

NCT03345407 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2008792017-001074-42
• Study Type: interventional
• Target: 943
• Locations: 16 countries
• Sites: 161

Brief Summary

Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses \[up to 750 micrograms (µg)\] compared with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in this double-blind study. Subjects will be randomized to receive different doses of nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Nemiralisib; Dose-Finding; GSK2269557; Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 84 Measured Post Bronchodilator

  FEV1 is maximal amount of air exhaled forcefully from lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered 4 inhalations of albuterol (salbutamol) via MDI using spacer/valved-holding chamber or via one nebulized treatment. Post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and post-bronchodilator. Change from Baseline in clinic visit trough FEV1 at Day 84 measured post-bronchodilator is FEV1 measured prior to dosing and post-bronchodilator on Day 84 minus post-bronchodilator Baseline FEV1. Bayesian repeated measure model adjusted for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender was used. Posterior adjusted median change from Baseline and 95% highest posterior density (HPD) credible interval (CrI) was presented.

  Baseline and Day 84

Secondary Outcomes (20)

• Rate of Moderate and Severe Exacerbations Over 12-week Treatment Period

  Up to Week 12

• Number of Participants With Time to Next Moderate/Severe Exacerbation Following Index Exacerbation

  Up to Week 12

• Change From Baseline in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator

  Baseline and Days 14, 28, 56 (pre and post bronchodilaor), 84 (pre-bronchodilator) and at hospital discharge (maximum 24 Weeks)

• Change From Hospital Discharge in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator

  Baseline and pre- and post-bronchodilator on Days 14, 28, 56 and 84

• Percentage of Participants Achieving the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Definition of Recovery From the Index Exacerbation

  Days 14, 28, 56 and 84

Other Outcomes (5)

• Area Under the Concentration Time Curve (AUC) From Time Zero to 24 Hours [AUC(0-24)] of Nemiralisib

  Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28

• AUC From Time Zero to Time 't' [AUC(0-t)] of Nemiralisib

  Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28

• Maximum Observed Plasma Drug Concentration (Cmax) of Nemiralisib

  Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28

Study Arms (6)

placebo once daily

PLACEBO COMPARATOR

Eligible subjects will receive placebo ELLIPTA dry powder (blended with lactose) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Drug: Placebo ELLIPTA; Drug: Albuterol (Salbutamol) MDI or nebules; Drug: Standard of care therapy

Nemiralisib 50 µg once daily

EXPERIMENTAL

Eligible subjects will receive nemiralisib ELLIPTA 50 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Drug: Nemiralisib ELLIPTA 50 µg; Drug: Albuterol (Salbutamol) MDI or nebules; Drug: Standard of care therapy

Nemiralisib 100 µg once daily

EXPERIMENTAL

Eligible subjects will receive nemiralisib ELLIPTA 100 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Drug: Nemiralisib ELLIPTA 100 µg; Drug: Albuterol (Salbutamol) MDI or nebules; Drug: Standard of care therapy

Nemiralisib 250 µg once daily

EXPERIMENTAL

Eligible subjects will receive nemiralisib ELLIPTA 250 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Drug: Nemiralisib ELLIPTA 250 µg; Drug: Albuterol (Salbutamol) MDI or nebules; Drug: Standard of care therapy

Nemiralisib 500 µg once daily

EXPERIMENTAL

Eligible subjects will receive nemiralisib ELLIPTA 500 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Drug: Nemiralisib ELLIPTA 500 µg; Drug: Albuterol (Salbutamol) MDI or nebules; Drug: Standard of care therapy

Nemiralisib 750 µg once daily

EXPERIMENTAL

Eligible subjects will receive nemiralisib ELLIPTA 750 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Drug: Nemiralisib ELLIPTA 750 µg; Drug: Albuterol (Salbutamol) MDI or nebules; Drug: Standard of care therapy

Interventions

Placebo ELLIPTA DRUG

Placebo will be administered via oral inhalation route once daily in the morning.

placebo once daily

Nemiralisib ELLIPTA 50 µg DRUG

Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 50 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Nemiralisib 50 µg once daily

Nemiralisib ELLIPTA 100 µg DRUG

Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 100 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Nemiralisib 100 µg once daily

Nemiralisib ELLIPTA 250 µg DRUG

Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 250 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Nemiralisib 250 µg once daily

Nemiralisib ELLIPTA 500 µg DRUG

Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 500 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Nemiralisib 500 µg once daily

Nemiralisib ELLIPTA 750 µg DRUG

Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 750 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Nemiralisib 750 µg once daily

Albuterol (Salbutamol) MDI or nebules DRUG

Albuterol (Salbutamol) MDI or nebules will be provided to all subjects as a rescue medication.

Nemiralisib 100 µg once daily; Nemiralisib 250 µg once daily; Nemiralisib 50 µg once daily; Nemiralisib 500 µg once daily; Nemiralisib 750 µg once daily; placebo once daily

Standard of care therapy DRUG

SoC therapy for the index exacerbation is defined as treatment with oral/systemic corticosteroid (prednisone 40 mg/day or equivalent) for 5 days and antibiotic for 7 days. Subjects will receive SoC as prescribed by the Investigator or medically qualified designee. The dose and/or duration of prednisone and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice.

Nemiralisib 100 µg once daily; Nemiralisib 250 µg once daily; Nemiralisib 50 µg once daily; Nemiralisib 500 µg once daily; Nemiralisib 750 µg once daily; placebo once daily

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age, inclusive, at Screening (Visit 1).
• An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society \[ global initiative for chronic obstructive lung disease (GOLD), 2017\] as follows: "Chronic obstructive pulmonary disease is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases."
• Current or former cigarette smoker with a history of cigarette smoking of \>=10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (Visit 1). Number of pack years = (number of cigarettes per day / 20) x number of years smoked).
• Acute exacerbation of COPD requiring an escalation in therapy to include oral/systemic corticosteroid(s) (prednisone 40 mg/day or equivalent) for 5 days and antibiotic(s) for 7 days; the dose and/or duration of prednisone (40 mg/day or equivalent) and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice. Acute exacerbation to be confirmed by an experienced physician and to represent a recent worsening of at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms. Major symptoms include subjective increase in dyspnea, increase in sputum volume or change in sputum color. Minor symptoms include increased cough, increased wheeze, sore throat, colds or fever (oral temperature \>37.5 degree Celsius) without other cause.
• Body weight \>=45 kilogram (kg) and body mass index (BMI) within the range 16 - 35 kg per meter square (kg/m\^2) (inclusive)
• Male and female subjects are eligible to participate in the study. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the 12-Week Double-Blind Treatment Period and for at least 5 half-lives (10 days) after the last of double-blind study treatment.
• Capable of giving signed informed consent.

You may not qualify if:

• Current diagnosis of asthma, according to the Global Initiative for Asthma (GINA, 2017). Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
• Potential of hydrogen (pH) \< 7.30 or the need for invasive mechanical ventilation.
• Moderate/severe exacerbation of COPD for which SoC was started \>48 hours since diagnosis.
• A chest X-ray \[or computed tomography (CT) scan\] that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray (or CT scan) must be taken at Screening (Visit 1). For sites in Germany: if a chest X-ray (or CT scan) within 1 year of Screening (Visit 1) is not available, approval to conduct a diagnostic chest X-ray (CT scan) will need to be obtained from the Federal Office for Radiation Protection (BfS).
• Clinically significant pneumonia, identified by chest X-ray (CT scan) at Screening.
• A history or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., subjects requiring implanted cardioverter defibrillator \[ICD\], pacemaker requiring a rate set \>60 beats per minute (bpm), uncontrolled hypertension, New Your Heart Association Class IV \[NYHA, 1994\], known left ventricular ejection fraction \<30 percent) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or hematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. (Note: subjects with adequately treated and well controlled concurrent medical conditions (e.g. hypertension or noninsulin-dependent diabetes mellitus \[NIDDM\]) are permitted to be entered into the study).
• Having undergone lung volume reduction surgery or lung resection for any other reason e.g. lung carcinoma
• Liver diseases including ALT\>2x upper limit of normal (ULN); Total bilirubin \>1.5xULN (Isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent); current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to first dose of study treatment; Positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study treatment.
• Positive hepatitis C ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
• Carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin are not excluded if the subject has been considered cured within 5 years since diagnosis.
• History of allergy or hypersensitivity to any of the study medications \[e.g. beta-agonists, Phosphoinositide 3-Kinase Delta (PI3Kd) inhibitors\] or components of the inhalation powder (e.g., lactose). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation are excluded.
• Strong inhibitors of cytochrome P450 3A4 (CYP3A4) including antiretrovirals including protease inhibitors; Oral antifungal treatments such as ketoconazole and itraconazole. It is recommended that posaconazole is used as the oral antifungal treatment of choice. Short courses of up to 14 days are allowed for fluconazole and voriconazole, but chronic administrations are not permitted; Antibiotics such as telithromycin and troleandomycin (macrolide). It is recommended that azithromycin is used as the macrolide antibiotic of choice. Short courses up to 14 days are allowed for mibefradil (calcium channel blocker), erythromycin and clarithromycin (including intravenous clarithromycin) but chronic administrations are not permitted; Anti-epileptic treatments; and anti-tuberculosis therapy. These medications must all have been stopped at least 14 days prior to first dose of study treatment. Use of sensitive narrow therapeutic index CYP3A4 substrates including alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus; Intravenous theophylline will be allowed but only under strict therapeutic drug monitoring for signs of theophylline toxicity as a result of co-administration with nemiralisib; Subjects may be recruited into the study already under treatment with theophylline or started on theophylline following the start of treatment and before the end of 14 days post last dose.
• Chronic treatment with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), or any other immunosuppressive therapy within 60 days prior to the first dose of double-blind study treatment.
• Clinically significant sleep apnea that requires the use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) for \> 48 hours.
• Any other investigational treatment within the following time periods prior to the first dose of double-blind study treatment in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer. Note: subjects who participated in a previously completed study and/or were withdrawn from an ongoing study that included/includes nemiralisib are excluded from participating in this study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (161)

GSK Investigational Site

Mobile, Alabama, 36608, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

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GSK Investigational Site

Daytona Beach, Florida, 32117, United States

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GSK Investigational Site

St. Petersburg, Florida, 33704, United States

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GSK Investigational Site

Adairsville, Georgia, 30103, United States

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GSK Investigational Site

Woodstock, Georgia, 30189, United States

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GSK Investigational Site

Columbia, Maryland, 21044, United States

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Chesterfield, Missouri, 63017, United States

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GSK Investigational Site

Saint Charles, Missouri, 63301, United States

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GSK Investigational Site

Omaha, Nebraska, 68134, United States

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Gastonia, North Carolina, 28054, United States

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Cincinnati, Ohio, 45231, United States

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Dayton, Ohio, 45459, United States

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Erie, Pennsylvania, 16508, United States

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Charleston, South Carolina, 29406-7108, United States

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Spartanburg, South Carolina, 29303, United States

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Rapid City, South Dakota, 57702, United States

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Abingdon, Virginia, 24210, United States

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Richmond, Virginia, 23225, United States

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Richmond, Virginia, 23229, United States

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Morgantown, West Virginia, 26505, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina

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Florida, Buenos Aires, 1602, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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San Rafael, Mendoza Province, 5600, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Santo Tomé, Santa Fe Province, 3016, Argentina

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Buenos Aires, C1280AEB, Argentina

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Buenos Aires, C1424BSF, Argentina

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Buenos Aires, C1425BEN, Argentina

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Buenos Aires, C1426ABP, Argentina

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Mendoza, 5500, Argentina

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Mendoza, M5500CCG, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Gosford, New South Wales, 2250, Australia

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Westmead, New South Wales, 2145, Australia

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Woolloongabba, Queensland, 4102, Australia

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Woodville South, South Australia, 5011, Australia

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Clayton, Victoria, 3168, Australia

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Murdoch, Western Australia, 6150, Australia

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Edmonton, Alberta, T6G 2G3, Canada

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Sherwood Park, Alberta, T8H 0N2, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Montreal, Quebec, H3T1E2, Canada

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Québec, Quebec, G1V 4G5, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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GSK Investigational Site

Brest, 29609, France

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Lyon, 69004, France

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Montpellier, 34295, France

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Rennes, 35033, France

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GSK Investigational Site

Vandœuvre-lès-Nancy, 54511, France

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Aschaffenburg, Bavaria, 63739, Germany

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Bamberg, Bavaria, 96049, Germany

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Rosenheim, Bavaria, 83022, Germany

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Potsdam, Brandenburg, 14467, Germany

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Darmstadt, Hesse, 64283, Germany

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Frankfurt am Main, Hesse, 60389, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Hanover, Lower Saxony, 30173, Germany

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Rheine, North Rhine-Westphalia, 48431, Germany

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Warendorf, North Rhine-Westphalia, 48231, Germany

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Koblenz, Rhineland-Palatinate, 56068, Germany

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Leipzig, Saxony, 04103, Germany

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Geesthacht, Schleswig-Holstein, 21502, Germany

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Lübeck, Schleswig-Holstein, 23558, Germany

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Schleswig, Schleswig-Holstein, 24837, Germany

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Berlin, 12203, Germany

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Reggio Emilia, Emilia-Romagna, 42100, Italy

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Rome, Lazio, 00133, Italy

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Rome, Lazio, 00189, Italy

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Milan, Lombardy, 20122, Italy

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Pavia, Lombardy, 27100, Italy

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Tradate (VA), Lombardy, 21049, Italy

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Catania, Sicily, 95123, Italy

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Messina, Sicily, 98125, Italy

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Negrar, Veneto, 37024, Italy

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Guadalajara, Jalisco, 44100, Mexico

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Zapopan, Jalisco, 45070, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Alkmaar, 1815 JD, Netherlands

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Breda, 4818 CK, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Groningen, 9728 NT, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Hoorn, 1624 NP, Netherlands

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Rotterdam, 3083 AN, Netherlands

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Utrecht, 3543 AZ, Netherlands

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Zwolle, 8025 AB, Netherlands

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Bialystok, 15-044, Poland

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Elblag, 82-300, Poland

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Krakow, 31-209, Poland

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Lubin, 59-300, Poland

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Oława, 55-200, Poland

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Ruda Śląska, 41-709, Poland

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Sosnowiec, 41-200, Poland

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Słupsk, 76-200, Poland

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Tarnów, 33-100, Poland

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GSK Investigational Site

Bucharest, 030303, Romania

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Bucharest, 050159, Romania

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GSK Investigational Site

Cluj-Napoca, 400015, Romania

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GSK Investigational Site

Comuna Alexandru Cel Bun, 617507, Romania

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Iași, 700115, Romania

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GSK Investigational Site

Oradea, 410176, Romania

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GSK Investigational Site

Râmnicu Vâlcea, 240564, Romania

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Suceava, 720284, Romania

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Timișoara, 300310, Romania

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GSK Investigational Site

Barnaul, 656 045, Russia

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Belgorod, 308007, Russia

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GSK Investigational Site

Blagoveshchensk, 675000, Russia

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GSK Investigational Site

Chelyabinsk, 454048, Russia

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GSK Investigational Site

Chelyabinsk, 454106, Russia

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Ivanovo, 153005, Russia

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GSK Investigational Site

Kemerovo, 650000, Russia

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GSK Investigational Site

Nizhny Novgorod, 603011, Russia

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GSK Investigational Site

Novosibirsk, 630102, Russia

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GSK Investigational Site

Perm, 614109, Russia

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Ryazan, 390039, Russia

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Saratov, 410028, Russia

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GSK Investigational Site

Tomsk, 634003, Russia

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GSK Investigational Site

Ulyanovsk, 432063, Russia

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GSK Investigational Site

Veliky Novgorod, 173008, Russia

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GSK Investigational Site

Voronezh, 394066, Russia

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GSK Investigational Site

Daejeon, 35365, South Korea

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Incheon, 21431, South Korea

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Jeonju-si, Jeollabuk-do, 54907, South Korea

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Seongnam-si, Gyeonggi-do, 463-707, South Korea

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Seoul, 02559, South Korea

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Seoul, 136-705, South Korea

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Seoul, 137-701, South Korea

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Seoul, 143-729, South Korea

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Seoul, 150-713, South Korea

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Seoul, 156-755, South Korea

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GSK Investigational Site

Laredo, Cantabria, 39770, Spain

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GSK Investigational Site

Barcelona, 08003, Spain

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Basurto/Bilbao, 48013, Spain

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Cartagena (Murcia), 30202, Spain

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Cáceres, 10003, Spain

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Elda (Alicante), 03600, Spain

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Girona, 17007, Spain

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Logroño, 26006, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28046, Spain

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Mérida (Badajoz), 06800, Spain

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Orihuela (Alicante), 03314, Spain

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Palma de Mallorca, 07198, Spain

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Pama de Mallorca, 07010, Spain

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Ponferrada (León), 24411, Spain

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Pozuelo de Alarcón/Madrid, 28223, Spain

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Gothenburg, SE-413 45, Sweden

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Lund, SE-221 85, Sweden

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Chesterfield, Derbyshire, S40 4AA, United Kingdom

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Wishaw, Lanarkshire, ML2 0DP, United Kingdom

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GSK Investigational Site

Blackburn, BB2 3HH, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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GSK Investigational Site

Edgbaston, B15 2GW, United Kingdom

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Edinburgh, EH16 4SA, United Kingdom

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Liverpool, L9 7AL, United Kingdom

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GSK Investigational Site

Sheffield, S5 7AU, United Kingdom

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GSK Investigational Site

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Related Publications (1)

• Fahy WA, Homayoun-Valiani F, Cahn A, Robertson J, Templeton A, Meeraus WH, Wilson R, Lowings M, Marotti M, West SL, Tabberer M, Hessel EM. Nemiralisib in Patients with an Acute Exacerbation of COPD: Placebo-Controlled, Dose-Ranging Study. Int J Chron Obstruct Pulmon Dis. 2021 Jun 3;16:1637-1646. doi: 10.2147/COPD.S309320. eCollection 2021.

  PMID: 34113095 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double blind, sponsor- open study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive either nemiralisib (50-750 µg) or placebo in a parallel group.

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: November 28, 2017
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: July 14, 2021
• Results First Posted: February 10, 2020

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• 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.

Locations

US (21); AR (13); KR (10); RU (16); RO (9); ME (3); GB (9); IT (9); PL (9); SE (2); AU (6); CA (7); FR (5); DE (16); NL (9); ES (17)