Respiratory DisordersPhase 1NCT01587807

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057

A Phase 1 study testing GSK1995057, bronchoalveolar lavage and LPS in people with Respiratory Disorders, run by GlaxoSmithKline at 2 sites in United Kingdom.

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Disorders
What is being tested?: GSK1995057, bronchoalveolar lavage and LPS
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 2 sitesUnited Kingdom
Study dates: 28 Mar 2012to 19 Nov 2012
Phase: Phase 1
Are there results?: None posted in the registry

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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests nd cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The investigator may discuss with GSK medical monitor as required.
Male or female between 18 and 55 years of age inclusive: A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit.
Normal creatinine clearance values at screening (calculated from serum creatinine by a predicting equation using Cockcroft-Gault formula), normal serum creatinine value as defined by the local reference laboratory, normal urine microscopy and no significant proteinuria on dipstick testing.
Body weight greater than and equal to 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
No evidence of previous or active TB infection and a negative QuantiFERON TB Gold test taken within 7 days of dosing, and negative medical history with respect to active or latent mycobacterium tuberculosis complex infection.
Normal spirometry (FEV1 greater than and equal to 85% of predicted, FEV1/FVC ratio greater than and equal to 70%) at screening. Predictions should be according to ECCS equations, and race corrections should be made for non-caucasians.

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Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Available to complete all study assessments.
Subjects who are able to use the inhaler device correctly.
Able to read, comprehend and write English at a sufficient level to complete study related materials.

Who cannot join

A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
A positive pre-study drug/alcohol screen.
History of and/or a positive test for toxoplasmosis consistent with active toxoplasmosis infection at the time of enrollment.
A positive RT-PCR test for influenza A/B.
Current evidence or history of an influenza-like illness as defined by fever (greater than 380C) and two or more of the following symptoms within the last 7 days: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhoea in the absence of a known cause, other than influenza.

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Corrected QT interval (QTc) >450msec.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits.
Subjects with a smoking history of greater than 5 cigarettes per day in the last 3 months (Part 1); smokers are not eligible to take part in Part 2.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

GSK Investigational Site
Belfast, BT9 6AD
GSK Investigational Site
Harrow, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Two-part, Randomised, Placebo-controlled Study to Investigatethe Safety, Tolerability, Pharmacokinetics and Pharmacodynamicsof Single Doses of Inhaled GSK1995057 in Healthy Subjects

GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a single-dose, parallel group design comprising 2 groups of healthy subjects assessing the effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose administered in Part 2 will be determined from emerging safety and PK data from Part 1 and Study TFR110951.

Read the detailed description

This study will be a randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inhaled GSK1995057 in healthy subjects. The study consists of 2 parts with a total of 6 cohorts. Part 1 will be conducted singleblind and Part 2 will be conducted single-blind with restrictions (i.e. subject and investigator only). The GSK Study Team and site pharmacist will remain unblinded to treatment allocation. Cohorts 1, 2, 3 and 4 (in Part 1) will receive a single inhaled dose of GSK1995057 or placebo. Cohort 5 will receive a single inhaled dose of GSK1995057 and in addition will have a bronchoalveolar lavage (BAL) sampling procedure conducted approximately 30 minutes post GSK1995057 dose. Subjects in Cohort 6 (Part 2) will be randomised to receive a high dose of GSK1995057 or placebo followed by an inhaled LPS challenge and BAL sampling procedure. Subjects will be required to visit the clinic over the course of 28 days after their dosing period for a follow up. Further visits for immunogenicity sampling may be conducted at 56 and 84 days post-first dose for subjects who show changes indicating a positive ADA response after dosing. Doses levels stipulated within the protocol are target doses based on predictions using the PK/PD model described in Section 1.2.2 of the clinical protocol. Part 1 will commence first and following acceptable safety and tolerability data will allow initiation of Part 2. All cohorts will participate in a single study session only.

Conditions: Respiratory Disorders
Being tested: GSK1995057, bronchoalveolar lavage, LPS, Placebo
Keywords: Infection, Quality of Life, lung injury
Medical subject headings: Respiration Disorders, Infections, Lung Injury

What participants receive

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

GSK1995057Drug
inhaled dose (volume based on cohort)
bronchoalveolar lavageProcedure or surgery
BAL
LPSDrug
50 μg
PlaceboDrug
Sucrose, glycine, sodium dihydrogen phosphate and polysorbate 80 (volume to match active dose)

Study groups in NCT01587807
Study group	Role	What they receive
Cohort 1	Experimental	single inhaled dose of GSK1995057 (dose 1) or placebo Receives: Drug: GSK1995057; Drug: Placebo
Cohort 2	Experimental	single inhaled dose of GSK1995057 (dose 2) or placebo Receives: Drug: GSK1995057
Cohort 3	Experimental	single inhaled dose of GSK1995057 (dose 3) or placebo Receives: Drug: Placebo
Cohort 4	Experimental	single inhaled dose of GSK1995057 (dose 4) or placebo Receives: Drug: Placebo
Cohort 5	Experimental	single inhaled dose GSK1995057 (dose 4) with bronchoalveolar lavage (BAL)sampling procedure conducted approximately 30 minutes post GSK1995057 dose Receives: Drug: GSK1995057
Cohort 6	Experimental	high dose of GSK1995057 or placebo followed by an inhaled LPS challenge and BAL sampling procedure. Receives: Drug: GSK1995057; Procedure: bronchoalveolar lavage; Drug: LPS; Drug: Placebo

What is being measured

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

Safety and tolerability of ascending single inhaled doses of GSK1995057
Adverse event reporting, Laboratory safety data (clinical chemistry, hematology, urinalysis), Vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG monitoring, Spirometry monitoring (FEV1, FVC)
Measured: 56 Days
Levels and specificity of anti-GSK1995057 binding antibodies.
Presence of anti GSK1995057 binding antibodies. Where binding antibodies aredetected, levels and specificity of the antibodies will be evaluated
Measured: Up to 84 Days
Plasma pharmacokinetics of ascending single inhaled doses of GSK1995057
Plasma concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following single administration (all except Cohort 5).
Measured: 3 days
Urine pharmacokinetics of single inhaled doses of GSK1995057
Urine concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following a single administration (Part 1, except Cohort 5).
Measured: 3 Days
Concentration of GSK1995057 in lung epithelial lining fluid after inhalation of a single dose
Bronchoalveolar lavage (BAL) concentrations of GSK1995057 and derived lung deposition parameters in normal healthy subjects following a single administration (Cohorts 5 \& 6 only). Bronchoalveolar lavage (BAL) concentrations of urea (Cohorts 5 \& 6 only).
Measured: 1 Day
Effect of single inhaled doses of GSK1995057 on biomarkers
Pharmacodynamic and immune function biomarkers in serum (these may include but are not limited to sTNFR1 (free and total) and IL-6) (all except Cohort 5).
Measured: 3 Days
Effect of single inhaled doses of GSK1995057 on biomarkers in BAL
Bronchoalveolar lavage (BAL) neutrophil counts at 6 h post LPS exposure (Cohort 5). Other pharmacodynamic and immune function biomarkers in BAL (these may include but are not limited to TNFα and IL-6) (Cohort 5).
Measured: 1 Day
To explore the GSK1995057 PK-PD relationship
Pharmacodynamic and immune function biomarkers in serum and BALF (these may include but are not limited to sTNFR1 (free and total) and IL-6). Bronchoalveolar lavage (BAL) concentrations of GSK1995057 and derived lung deposition parameters in normal healthy subjects following a single administration (Cohort 5 and 6 only). Bronchoalveolar lavage (BAL) concentrations of urea (Cohorts 5 and 6 only). Change from baseline in IL-8 expression in ex vivo whole blood assay (WBA).
Measured: 1 Day

Timeline

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

28 Mar 201219 Nov 2012

First posted30 Apr 2012 (estimated)
Study start28 Mar 2012
Primary completion19 Nov 2012
Study completion19 Nov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Respiratory DisordersStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01587807
Sponsor's protocol ID: 116236
Other IDs: 2011-005245-13
Status last verified: Jun 2019
First submitted: 29 Mar 2012
Last updated: 27 Jun 2019
Results posted: No

Publications

Proudfoot AG, O'Kane CM, Bayliffe A, Serone AP, Bareille P, Smith SP, Brown V, Wright TJ, Chen Y, Wilson R, Cordy JC, Morley PJ, Elborn S, Hind M, Chilvers ER, Griffiths MJ, Summers C, McAuley DF . A novel TNFR1-targeting domain antibody attenuates pulmonary inflammation in a human model of lung injury, via actions on the lung micro-vascular endothelium.. American Journal of Respiratory and Critical Care Medicine. 2014;189:A6589
Proudfoot A, Bayliffe A, O'Kane CM, Wright T, Serone A, Bareille PJ, Brown V, Hamid UI, Chen Y, Wilson R, Cordy J, Morley P, de Wildt R, Elborn S, Hind M, Chilvers ER, Griffiths M, Summers C, McAuley DF. Novel anti-tumour necrosis factor receptor-1 (TNFR1) domain antibody prevents pulmonary inflammation in experimental acute lung injury. Thorax. 2018 Aug;73(8):723-730. doi: 10.1136/thoraxjnl-2017-210305. Epub 2018 Jan 29.
PubMed 29382797

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-part, Randomised, Placebo-controlled Study to Investigatethe Safety, Tolerability, Pharmacokinetics and Pharmacodynamicsof Single Doses of Inhaled GSK1995057 in Healthy Subjects
ClinicalTrials.gov ID: NCT01587807
Acronym / sponsor ID: 116236
Conditions: Respiratory Disorders
Keywords: Infection, Quality of Life, lung injury
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Mar 2012 (actual)
Primary completion: 19 Nov 2012 (actual)
Study completion: 19 Nov 2012 (actual)
First posted: 30 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Cohort 1	Experimental	Drug: GSK1995057, Drug: Placebosingle inhaled dose of GSK1995057 (dose 1) or placebo
Cohort 2	Experimental	Drug: GSK1995057single inhaled dose of GSK1995057 (dose 2) or placebo
Cohort 3	Experimental	Drug: Placebosingle inhaled dose of GSK1995057 (dose 3) or placebo
Cohort 4	Experimental	Drug: Placebosingle inhaled dose of GSK1995057 (dose 4) or placebo
Cohort 5	Experimental	Drug: GSK1995057single inhaled dose GSK1995057 (dose 4) with bronchoalveolar lavage (BAL)sampling procedure conducted approximately 30 minutes post GSK1995057 dose
Cohort 6	Experimental	Drug: GSK1995057, Procedure: bronchoalveolar lavage, Drug: LPS, Drug: Placebohigh dose of GSK1995057 or placebo followed by an inhaled LPS challenge and BAL sampling procedure.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests nd cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The investigator may discuss with GSK medical monitor as required.
Male or female between 18 and 55 years of age inclusive: A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit.
Normal creatinine clearance values at screening (calculated from serum creatinine by a predicting equation using Cockcroft-Gault formula), normal serum creatinine value as defined by the local reference laboratory, normal urine microscopy and no significant proteinuria on dipstick testing.
Body weight greater than and equal to 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
No evidence of previous or active TB infection and a negative QuantiFERON TB Gold test taken within 7 days of dosing, and negative medical history with respect to active or latent mycobacterium tuberculosis complex infection.

Key exclusion criteria (10 listed)

A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
A positive pre-study drug/alcohol screen.
History of and/or a positive test for toxoplasmosis consistent with active toxoplasmosis infection at the time of enrollment.
A positive RT-PCR test for influenza A/B.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK1995057inhaled dose (volume based on cohort)	Drug	Cohort 1, Cohort 2, Cohort 5, Cohort 6
bronchoalveolar lavageBAL	Procedure or surgery	Cohort 6
LPS50 μg	Drug	Cohort 6
PlaceboSucrose, glycine, sodium dihydrogen phosphate and polysorbate 80 (volume to match active dose)	Drug	Cohort 1, Cohort 3, Cohort 4, Cohort 6

Primary outcome

Safety and tolerability of ascending single inhaled doses of GSK1995057
Time frame: 56 Days
Adverse event reporting, Laboratory safety data (clinical chemistry, hematology, urinalysis), Vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG monitoring, Spirometry monitoring (FEV1, FVC)
Levels and specificity of anti-GSK1995057 binding antibodies.
Time frame: Up to 84 Days
Presence of anti GSK1995057 binding antibodies. Where binding antibodies aredetected, levels and specificity of the antibodies will be evaluated
Plasma pharmacokinetics of ascending single inhaled doses of GSK1995057
Time frame: 3 days
Plasma concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following single administration (all except Cohort 5).
Urine pharmacokinetics of single inhaled doses of GSK1995057
Time frame: 3 Days
Urine concentrations of GSK1995057 and derived pharmacokinetic parameters in normal healthy subjects following a single administration (Part 1, except Cohort 5).
Concentration of GSK1995057 in lung epithelial lining fluid after inhalation of a single dose
Time frame: 1 Day
Bronchoalveolar lavage (BAL) concentrations of GSK1995057 and derived lung deposition parameters in normal healthy subjects following a single administration (Cohorts 5 \& 6 only). Bronchoalveolar lavage (BAL) concentrations of urea (Cohorts 5 \& 6 only).
Effect of single inhaled doses of GSK1995057 on biomarkers
Time frame: 3 Days
Pharmacodynamic and immune function biomarkers in serum (these may include but are not limited to sTNFR1 (free and total) and IL-6) (all except Cohort 5).
Effect of single inhaled doses of GSK1995057 on biomarkers in BAL
Time frame: 1 Day
Bronchoalveolar lavage (BAL) neutrophil counts at 6 h post LPS exposure (Cohort 5). Other pharmacodynamic and immune function biomarkers in BAL (these may include but are not limited to TNFα and IL-6) (Cohort 5).
To explore the GSK1995057 PK-PD relationship
Time frame: 1 Day
Pharmacodynamic and immune function biomarkers in serum and BALF (these may include but are not limited to sTNFR1 (free and total) and IL-6). Bronchoalveolar lavage (BAL) concentrations of GSK1995057 and derived lung deposition parameters in normal healthy subjects following a single administration (Cohort 5 and 6 only). Bronchoalveolar lavage (BAL) concentrations of urea (Cohorts 5 and 6 only). Change from baseline in IL-8 expression in ex vivo whole blood assay (WBA).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
BackgroundProudfoot AG, O'Kane CM, Bayliffe A, Serone AP, Bareille P, Smith SP, Brown V, Wright TJ, Chen Y, Wilson R, Cordy JC, Morley PJ, Elborn S, Hind M, Chilvers ER, Griffiths MJ, Summers C, McAuley DF . A novel TNFR1-targeting domain antibody attenuates pulmonary inflammation in a human model of lung injury, via actions on the lung micro-vascular endothelium.. American Journal of Respiratory and Critical Care Medicine. 2014;189:A6589
Derived from this study: PubMed 29382797Proudfoot A, Bayliffe A, O'Kane CM, Wright T, Serone A, Bareille PJ, Brown V, Hamid UI, Chen Y, Wilson R, Cordy J, Morley P, de Wildt R, Elborn S, Hind M, Chilvers ER, Griffiths M, Summers C, McAuley DF. Novel anti-tumour necrosis factor receptor-1 (TNFR1) domain antibody prevents pulmonary inflammation in experimental acute lung injury. Thorax. 2018 Aug;73(8):723-730. doi: 10.1136/thoraxjnl-2017-210305. Epub 2018 Jan 29.
Results for study 116236 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1995057, bronchoalveolar lavage and LPS in people with Respiratory Disorders, run by GlaxoSmithKline at 2 sites in United Kingdom.

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 10 inclusion and 10 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 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability of ascending single inhaled doses of GSK1995057 (time frame: 56 Days). The study lists 8 primary outcomes in all. 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 NCT01587807, which also lists 2 linked publications.

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 27 Jun 2019.