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Pulmonary Disease, Chronic ObstructivePhase 2NCT02294734

An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease

A Phase 2 study testing GSK2269557 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 17 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety, tolerability and pharmacokinetic data. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
GSK2269557
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
17 sitesin 5 countries
Study dates
31 Mar 2015to 25 Apr 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 40 and 80 years of age inclusive, at the time of signing the informed consent
  • The subject has a confirmed and established diagnosis of COPD, as defined by the global initiative for chronic Obstructive Lung Disease (GOLD) guidelines for at least 6 months prior to entry.
  • The subject has a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.7 and FEV1 <= 80 % of predicted (Predictions should be according to the European Community of Coal and Steel [ECCS] equations), documented in the last 5 years.
  • Disease severity: Acute exacerbation of COPD requiring an escalation in therapy to include corticosteroid and antibiotics. Acute exacerbation to be confirmed by an experienced physician and represent a recent change in at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms. Major symptoms: subjective increase in dyspnea, increase in sputum volume, and change in sputum colour. Minor symptoms: cough, wheeze and sore throat.
  • The subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (pack years = [cigarettes per day smoked/20 x number of years smoked])
  • Body weight >= 45 kilogram (kg) and body mass index (BMI) within the range 18 - 32 kg/metered squared (m^2) (inclusive).
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  • Male
  • Female subject : is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies:
  • Non-reproductive potential defined as: Pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy and documented bilateral oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
  • Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until completion of the follow-up visit.
  • GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP):
  • Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
  • Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
  • Oral Contraceptive, either combined or progestogen alone. Injectable progestogen. Contraceptive vaginal ring. Percutaneous contraceptive patches. Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.
  • Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository).
  • Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until after the completion of the follow up visit.
  • Vasectomy with documentation of azoospermia. Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label. Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label. Oral Contraceptive, either combined or progestogen alone or injectable progestogen. Contraceptive vaginal ring. Percutaneous contraceptive patches.
  • These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the study protocol.

Who cannot join

  • To avoid recruitment of subjects with a severe COPD exacerbation, the presence of any one of the following severity criteria will render the subject ineligible for inclusion in the study:
  • Need for invasive mechanical ventilation (short term (< 48hour) Non-invasive Ventilation (NIV) or Continuous Positive Airway Pressure [CPAP] is acceptable).
  • Haemodynamic instability or clinically significant heart failure. Confusion.
  • Subjects who have a history or current medical conditions or diseases that are not well controlled and, which as judged by the Investigator, may affect subject safety or influence the outcome of the study. (Note: Patients with adequately treated and well controlled concurrent medical conditions [e.g. hypertension or non-insulin dependent diabetes mellitus] are permitted to be entered into the study).
  • Subject has a diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, pulmonary fibrosis, asthma or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results.
  • Alanine aminotransferase >2x upper limit of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
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  • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the exclusion criteria, outside of the reference range for the population being studied may be included if the Investigator [in consultation with the GSK Medical Monitor if required] documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • ECG indicative of an acute cardiac event (e.g. Myocardial Infarction) or demonstrating a clinically significant arrhythmia requiring treatment.
  • QTcF > 450 millisecond (msec) or QTcF > 480 msec in subjects with Bundle Branch Block, based on single QTcF value.
  • Subjects who have undergone lung volume reduction surgery.
  • Subject is currently on chronic treatment with macrolides; long term oxygen therapy (> 15 hours/day).
  • The subject has been on chronic treatment with anti-Tumour Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), or any other immunosuppressive therapy within 60 days prior to dosing.
  • History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >28 units for males or >21 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint ( equivalent to 240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
  • History of sensitivity to any of the study medications, or components thereof (such as lactose) or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
  • A known (historical) positive test for human immune virus (HIV) antibody.
  • Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. NOTE: Because of the short window for screening, treatment with GSK2269557 may start before receiving the result of the hepatitis tests. If subsequently the test is found to be positive, the subject may be withdrawn, as judged by the Principal Investigator in consultation with the Medical Monitor.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
  • 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 4 investigational medicinal products within 12 months prior to the first dosing day.

Trial locations and contacts

17 sites in 5 countries.

17 sites in 5 countries

Russia6 sites

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Moscow, 105 077

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Vladimir, 600023

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Denmark4 sites

  • GSK Investigational Site

    Aalborg, DK-9100

  • GSK Investigational Site

    Copenhagen, DK-2400

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    Odense, 5000 Odense C

Other trials in Denmark

Netherlands3 sites

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Belgium2 sites

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Erpent, 5101

Other trials in Belgium

Romania2 sites

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

About this study

Official title: A Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of GSK2269557 Administered in Addition to Standard of Care in Adult Subjects Diagnosed With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety, tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks including screening, treatment period and a follow up visit. Subjects will receive once daily study treatment administration starting on Day 1. Study is planned to recruit approximately 120 subjects such that approximately 100 subjects complete the study.

Being tested
GSK2269557, Placebo
Keywords
functional respiratory capacity, High-resolution computed tomography, GSK2269557, acute exacerbation of COPD, lung capacity
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK2269557Drug

    Dry powder for inhalation via DISKUS 'device' with unit dose strength of 500 micrograms (mcg) per actuation with total dose of 1000 mcg daily

  • PlaceboDrug

    Dry powder for inhalation via DISKUS 'device'

Study groups in NCT02294734
Study groupRoleWhat they receive
GSK2269557 repeat doseExperimentalParticipants will receive 2 inhalation of GSK2269557 dry powder once daily via DISKUS™ 'device' (DISKUS is a trademark of the GSK group of companies)
Receives: Drug: GSK2269557
Matching placebo repeat dosePlacebo comparatorParticipants will receive 2 inhalation matching placebo dry powder once daily via DISKUS 'device'
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28

    siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For longitudinal time points and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

    Measured: Baseline, Day 12 and Day 28

Secondary outcomes (23)

  1. Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28

    iVaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. Data was collected at longitudinal time points: Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For longitudinal time points and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

    Measured: Baseline, Day 12 and Day 28

  2. Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28

    iRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

    Measured: Baseline, Day 12 and Day 28

  3. Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28

    siRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

    Measured: Baseline, Day 12 and Day 28

  4. Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28

    Change from Baseline in lung lobar volumes was measured at functional residual volume (FRC) and total lung capacity (TLC) scan conditions. Data was collected at longitudinal time points: Day 12 \& Day 28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For longitudinal time points the baseline is screening. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

    Measured: Baseline, Day 12 and Day 28

  5. Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment

    Imaging trachea length and diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 12 and Day 28

  6. Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment

    Imaging trachea length/diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length/diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 12 and Day 28

  7. Number of Participants With Adverse Events (AE)

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were collected from the start of study treatment until the follow-up contact.

    Measured: From start of IP through the Study Phase (84 days post-dose) (assessed up to follow-up duration of approximately 100 days)

  8. Number of Participants With Abnormal Hematology Parameters

    Hematology parameter included Hematocrit (HCT), Hemoglobin (HB), Lymphocytes (LC), Platelet Count (PC), Total Neutrophils (TN), and White Blood Cell (WBC) count at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 Days)

  9. Number of Participants With Abnormal Clinical Chemistry Parameters

    Clinical Chemistry parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Calcium (Ca), Glucose, Potassium (K), Sodium (Na), and Total Bilirubin (TBL) at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)

  10. Number of Participants With Abnormal Vital Signs

    Vital signs included high and low diastolic and systolic blood presure (BP), and high and low heart rate (HR). Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline . Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)

  11. Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)

    12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Clinically non-significant (CN) and Clinically significant (CS) abnormal ECG measurements are presented for Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)

  12. Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose

    Plasma samples were collected at pre-dose, 5 minutes (min), 3 hrs, and 24 hrs post-dose on Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Population: all participants in the Safety Population for whom a PK sample was obtained and analyzed. Safety Population comprises of all participants who were randomized.

    Measured: Pre-dose, 5 min, 3 hrs and 24 hrs

  13. Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment

    Trough concentrations are presented for Pre-dose Day 12, Pre-dose Day 28, Pre-dose Day 56, and Pre-dose Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Pre-dose Day 12, Day 28, Day 56, and Day 84

  14. Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily

    FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 28, and Day 84

  15. Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily

    PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 28, and Day 84

  16. Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment

    DLco is diffusing capacity o f the lungs for carbon monoxide and is defined as the extent to which oxygen passes from the air sacs of the lungs into the blood. KCO is the carbon monoxide transfer coefficient. It is an index of the efficiency of alveolar transfer of carbon monoxide. Baseline is defined as the assessment on Day 2 and percent change from Baseline is the post-Baseline value minus Baseline value/100. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 28 and Day 84

  17. Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment

    TLC is the maximum amount of air that can fill the lungs. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.

    Measured: Baseline, Day 28 and Day 84

  18. Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment

    Residual volume is a lung volume representing the amount of air left in the lungs after a forced exhalation. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.

    Measured: Baseline, Day 28 and Day 84

  19. Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment

    Functional residual capacity is the volume of air present in the lungs at the end of passive expiration. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 28 and Day 84

  20. Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment

    sRaw is the measure of specific resistance. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 28 and Day 84

  21. Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment

    Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).Note: values mentioned as 95% confidence interval below are in fact values of 95% Credible Interval.

    Measured: Baseline, Day 28 and Day 84

  22. Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84

    The chronic obstructive pulmonary disease (COPD) assessement test (CAT) and Modified Medical Research Council (MMRC) Dyspnea Scale were completed at the indicated timepoints: Baseline, Day 28 and Day 84. CAT and MMRC scales are prestned as: 1.I never cough/I cough all the time 2.I have no phelgm in my chest at all/My chest is completely full of phelgm 3. My chest does not feel tight at all/My chest feels very tight 4.Walk up hilll or stairs not breathless/Walk up hill or stairs very breathless 5. Not limited doing any home activities/Very limited doing any home activities 6. Confident leaving home/No confident leaving home 7. I sleep soundly/I don't sleep soundly because of my lung condition and 8. I have lots of energy/I have no energy at all. Baseline is defined as the assessment on Day 1. Score 0 indicates not troubled with breathlessness to 4:too breathless. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

    Measured: Baseline, Day 28 and Day 84

  23. Number of Participants With Treatment Failures

    Treatment failure types are presented as: recurrent exacerbations, prolonged treatment of current exacerbation (beyond 14 days), additional treatment with systemic / oral corticosteroids and / or antibiotics, and requirement for invasive mechanical ventilation.

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2014 (estimated)
  2. Study start31 Mar 2015
  3. Primary completion19 Feb 2016
  4. Study completion25 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02294734
Sponsor's protocol ID
116678
Other IDs
2014-001972-70, 2014
Status last verified
Aug 2021
First submitted
17 Nov 2014
Last updated
12 Aug 2021
Data monitoring committee
No
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site

Publications

  • Cahn A, Hamblin JN, Robertson J, Begg M, Jarvis E, Wilson R, Dear G, Leemereise C, Cui Y, Mizuma M, Montembault M, Van Holsbeke C, Vos W, De Backer W, De Backer J, Hessel EM. An Inhaled PI3Kdelta Inhibitor Improves Recovery in Acutely Exacerbating COPD Patients: A Randomized Trial. Int J Chron Obstruct Pulmon Dis. 2021 Jun 3;16:1607-1619. doi: 10.2147/COPD.S309129. eCollection 2021.

    PubMed 34113093

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK2269557 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 17 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Russia, Denmark, Netherlands, Belgium, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28 (time frame: Baseline, Day 12 and Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02294734, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.

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