AsthmaPhase 2NCT01128595

Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response

A Phase 2 study testing FF/GW642444M, GW642444M and Fluticasone Furoate in people with Asthma, run by GlaxoSmithKline at 4 sites in 3 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

We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination product and its components on protection from allergic triggers in asthma Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: FF/GW642444M, GW642444M and Fluticasone Furoate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 4 sitesin 3 countries
Study dates: May 2010to May 2011
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
Females of non-child bearing potential.
Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
Pre-bronchodilator FEV1 >70% of predicted at screening
Subjects who are current non-smokers
Methacholine challenge PC20 < 8 mg/mL at screening
Screening allergen challenge demonstrates that the subject experiences an early asthmatic response

Who cannot join

Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Subject is hypertensive at screening
Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
History of life-threatening asthma
Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
Unable to abstain from short acting beta agonists

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Unable to abstain from antihistamines
Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months
undergoing allergen desensitisation therapy

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Sweden2 sites

GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Lund, SE-221 85

Other trials in Sweden

Australia1 site

GSK Investigational Site
Randwick, New South Wales, 2031

Other trials in Australia

New Zealand1 site

GSK Investigational Site
Wellington, 6021

Other trials in New Zealand

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Four-way Crossover, Repeat Dose Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination, GW642444M and Fluticasone Furoate on the Allergen-induced Asthmatic Response in Subjects With Mild Asthma

Read the detailed description

Asthma is an increasingly common disease and is essentially caused by an allergic type of reaction of the immune system. Airways of the lungs become inflamed and narrow as a result of a reaction to triggers like chemicals (house-hold cleaning products, pollution) and allergens (house dust mite and cat or dog fur). The airways become blocked, causing shortness of breath and wheezing. The purpose of this study is to find out more information about how effective the study drugs are at protecting the lungs against allergic triggers of asthma. There are three study drugs being investigated in this study: fluticasone furoate on its own, GW642444M on its own and a combination of fluticasone furoate (FF) and GW642444M.

FF is a corticosteroid that is being developed by for the treatment of asthma. A nasal spray formulation of FF has been approved for marketing in the USA, Europe and Japan for the treatment of hayfever (rhinitis) but the dry powder formulation used in this study is not yet approved.

GW642444M is a long-acting beta2-agonist being developed by GSK for the treatment of chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. The combination of FF/GW642444M is being developed as a once-daily treatment for both asthma and COPD.

Study treatment will be taken for 21 days in each period (4 treatment periods: FF alone, GW642444M alone, FF/GW64244M combination and placebo) and each subject will receive all treatments. On D21 subjects will undergo an allergen challenge, followed by a methacholine challenge on D22. The washout between treatment periods will be 21-35 days.

Conditions: Asthma
Being tested: FF/GW642444M, GW642444M, Fluticasone Furoate, Placebo
Keywords: allergen challenge, early asthmatic response, mild asthma, late asthmatic response
Medical subject headings: Asthma

What participants receive

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

FF/GW642444MDrug
GW642444MDrug
Fluticasone FuroateDrug
PlaceboDrug

Study groups in NCT01128595
Study group	Role	What they receive
ICS	Active comparator	Not described Receives: Drug: Fluticasone Furoate
ICS/LABA	Active comparator	Not described Receives: Drug: FF/GW642444M
LABA	Active comparator	Not described Receives: Drug: GW642444M
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Measured: Day 21 of each treatment period (up to Study Day 197)
LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Measured: Day 21 of each treatment period (up to Study Day 197)
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Measured: Day 21 of each treatment period (up to Study Day 197)
EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.
Measured: Day 21 of each treatment period (up to Study Day 197)

Secondary outcomes (2)

Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Maximum percent change was calculated as the minimum FEV1 minus the saline FEV1 value divided by the saline FEV1 multiplied by 100. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline FEV1 value.
Measured: Day 21 of each treatment period (up to Study Day 197)
Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% fall in FEV1 from the saline value was achieved. After inhalation of saline, 3 measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.
Measured: Day 22 of each treatment period (up to Study Day 198)

Timeline

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

May 2010May 2011

First posted24 May 2010 (estimated)
Study startMay 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01128595
Sponsor's protocol ID: 113126
Status last verified: Nov 2016
First submitted: 20 May 2010
Last updated: 18 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Four-way Crossover, Repeat Dose Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination, GW642444M and Fluticasone Furoate on the Allergen-induced Asthmatic Response in Subjects With Mild Asthma
ClinicalTrials.gov ID: NCT01128595
Acronym / sponsor ID: 113126
Conditions: Asthma
Keywords: allergen challenge, early asthmatic response, mild asthma, late asthmatic response
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 24 May 2010 (estimated)
Results: Posted 9 Aug 2013

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
ICS	Active comparator	Drug: Fluticasone Furoate
ICS/LABA	Active comparator	Drug: FF/GW642444M
LABA	Active comparator	Drug: GW642444M
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
Females of non-child bearing potential.
Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
Pre-bronchodilator FEV1 >70% of predicted at screening
Subjects who are current non-smokers

Key exclusion criteria (10 listed)

Current or chronic history of liver disease, or known hepatic or biliary abnormalities

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
FF/GW642444M	Drug	ICS/LABA
GW642444M	Drug	LABA
Fluticasone Furoate	Drug	ICS
Placebo	Drug	Placebo

Primary outcome

Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Time frame: Day 21 of each treatment period (up to Study Day 197)
Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Time frame: Day 21 of each treatment period (up to Study Day 197)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Time frame: Day 21 of each treatment period (up to Study Day 197)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Time frame: Day 21 of each treatment period (up to Study Day 197)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.

2 secondary outcomes

Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Time frame: Day 21 of each treatment period (up to Study Day 197)
Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period
Time frame: Day 22 of each treatment period (up to Study Day 198)

Results and safety

Results posted to the registry on 9 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg	7	7
Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg	6	6
Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg	7	7
Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo	7	7

Primary outcome: Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period

Time frame: Day 21 of each treatment period (up to Study Day 197). Least squares mean (95% Confidence Interval). Unit: Liters

Measure	Placebo n = 20	FF/VI 100/25 µg OD n = 26	FF 100 µg OD n = 27	VI 25 µg OD n = 22
Value	-0.731 (-0.878 to -0.584)	-0.216 (-0.343 to -0.088)	-0.188 (-0.315 to -0.061)	-0.536 (-0.676 to -0.396)

Placebo vs FF/VI 100/25 µg OD: Mean Difference (Final Values): 0.515 (95% CI 0.330 to 0.701)
Placebo vs FF 100 µg OD: Mean Difference (Final Values): 0.543 (95% CI 0.355 to 0.730)
Placebo vs VI 25 µg OD: Mean Difference (Final Values): 0.195 (95% CI 0.001 to 0.388)

Population analysed: Efficacy Population: all participants who received at least one dose of study medication, had a post-dose FEV1 assessment, and who were not major protocol violators. Only those participants available at the specified time points were analyzed.

Primary outcome: LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period

Time frame: Day 21 of each treatment period (up to Study Day 197). Least squares mean (95% Confidence Interval). Unit: Liters

Measure	Placebo n = 20	FF/VI 100/25 µg OD n = 26	FF 100 µg OD n = 27	VI 25 µg OD n = 22
Value	-0.466 (-0.589 to -0.343)	0.018 (-0.089 to 0.125)	0.018 (-0.089 to 0.124)	-0.298 (-0.415 to -0.181)

Placebo vs FF/VI 100/25 µg OD: Mean Difference (Final Values): 0.484 (95% CI 0.332 to 0.636)
Placebo vs FF 100 µg OD: Mean Difference (Final Values): 0.484 (95% CI 0.330 to 0.638)
Placebo vs VI 25 µg OD: Mean Difference (Final Values): 0.168 (95% CI 0.009 to 0.327)

Population analysed: Efficacy Population. Only those participants available at the specified time points were analyzed.

Primary outcome: Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period

Time frame: Day 21 of each treatment period (up to Study Day 197). Least squares mean (95% Confidence Interval). Unit: Liters

Measure	Placebo n = 22	FF/VI 100/25 µg OD n = 27	FF 100 µg OD n = 27	VI 25 µg OD n = 22
Value	-1.091 (-1.344 to -0.837)	-0.614 (-0.858 to -0.370)	-0.826 (-1.070 to -0.581)	-0.955 (-1.209 to -0.702)

FF/VI 100/25 µg OD vs FF 100 µg OD: Mean Difference (Final Values): 0.212 (95% CI 0.031 to 0.393)
FF/VI 100/25 µg OD vs VI 25 µg OD: Mean Difference (Final Values): 0.341 (95% CI 0.147 to 0.536)
Placebo vs FF/VI 100/25 µg OD: Mean Difference (Final Values): 0.477 (95% CI 0.282 to 0.672)

Population analysed: Efficacy Population. Only those participants available at the specified time points were analyzed.

Primary outcome: EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period

Time frame: Day 21 of each treatment period (up to Study Day 197). Least squares mean (95% Confidence Interval). Unit: Liters

Measure	Placebo n = 22	FF/VI 100/25 µg OD n = 27	FF 100 µg OD n = 27	VI 25 µg OD n = 22
Value	-0.560 (-0.745 to -0.374)	-0.297 (-0.476 to -0.118)	-0.386 (-0.565 to -0.207)	-0.533 (-0.718 to -0.348)

FF/VI 100/25 µg OD vs FF 100 µg OD: Mean Difference (Final Values): 0.089 (95% CI -0.037 to 0.215)
FF/VI 100/25 µg OD vs VI 25 µg OD: Mean Difference (Final Values): 0.236 (95% CI 0.101 to 0.371)
Placebo vs FF/VI 100/25 µg OD: Mean Difference (Final Values): 0.263 (95% CI 0.127 to 0.398)

Population analysed: Efficacy Population. Only those participants available at the specified time points were analyzed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the fourth treatment period (up to Day 210).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 27 (0%)	19 of 27 (70.4%)	Not reported
FF/VI 100/25 µg OD	0 of 27 (0%)	20 of 27 (74.1%)	Not reported
FF 100 µg OD	0 of 27 (0%)	19 of 27 (70.4%)	Not reported
VI 25 µg OD	0 of 26 (0%)	22 of 26 (84.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FF/GW642444M, GW642444M and Fluticasone Furoate in people with Asthma, run by GlaxoSmithKline at 4 sites in 3 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 7 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden, Australia, New Zealand. 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 Aug 2013). 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?

Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period (time frame: Day 21 of each treatment period (up to Study Day 197)). The study lists 4 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 NCT01128595.

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 18 Jan 2017.