AsthmaPhase 2NCT00980200

Efficacy and Safety Study in Subjects With Asthma

A Phase 2 study testing Dose 4 QD, Dose 3 QD and Dose 2 QD in people with Asthma, run by GlaxoSmithKline at 9 sites in United States.

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 study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Dose 4 QD, Dose 3 QD and Dose 2 QD
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 9 sitesUnited States
Study dates: Sep 2009to Jan 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatient
≥18 years of age at Visit 1
Male or Eligible Female
Diagnosis of asthma at least 12 weeks prior to Visit 1
Disease reversibility
Current anti-asthma therapy
Appropriately signed and dated informed consent has been obtained
Able to comply with all the study requirements

Who cannot join

History of Life-Threatening Asthma
No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
History of severe milk protein allergy
Non-compliance with study medication and other study-related requirements
No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Boerne, Texas, 78006
GSK Investigational Site
Cypress, California, 90630
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rolla, Missouri, 65401

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Five Period Cross-over Study to Evaluate the Efficacy and Safety of Selected Doses and Dose Intervals of GW642444 Administered Via a Novel Dry Powder Inhaler (NDPI) in Subjects ≥18 Years of Age With Persistent Asthma

Read the detailed description

The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .

Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.

Conditions: Asthma
Being tested: Dose 4 QD, Dose 3 QD, placebo, Dose 2 QD, Dose 1 BD
Keywords: GW642444, once daily dosing, asthma, efficacy, safety, FEV1
Medical subject headings: Asthma

What participants receive

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

Dose 4 QDDrug
QD once daily
Dose 3 QDDrug
QD once daily
placeboDrug
placebo
Dose 2 QDDrug
QD once daily
Dose 1 BDDrug
BD twice daily

Study groups in NCT00980200
Study group	Role	What they receive
C/E/A/B/D	Experimental	GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD Receives: Drug: Dose 2 QD
D/C/E/A/B	Experimental	GW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD Receives: Drug: Dose 3 QD
A/B/C/D/E	Experimental	placebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD Receives: Drug: placebo
B/A/D/E/C	Experimental	GW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD Receives: Drug: Dose 1 BD
E/D/B/C/A	Experimental	GW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo Receives: Drug: Dose 4 QD

What is being measured

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

Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.
Measured: Baseline and Day 7 of the treatment period (up to Study Day 63)

Secondary outcomes (1)

Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean was derived by calculating the average area under curve, and then dividing by the relevant time interval. 24-hour serial measurements of FEV1 were performed on Day 7 of each of the 5 treatment periods (Visits 3, 5, 7, 9, and 11). Measurements were taken at pre-dose; 30 and 60 minutes; and 3, 5, 11, 12, 12.5, 13, 15, 17, 23, and 24 hours post-dose. Visits 3, 5, 7, 9, and 11 were overnight visits. Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed effects analysis of covariance (ANCOVA) model, with fixed effects for treatment, period, sex, and age. Participant was fitted as a random effect, and the period Baseline FEV1 measurement was included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.
Measured: Baseline and Day 7 of the treatment period (up to Study Day 63)

Timeline

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

Sep 2009Jan 2010

First posted18 Sep 2009 (estimated)
Study startSep 2009
Primary completionJan 2010
Study completionJan 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00980200
Sponsor's protocol ID: 113310
Status last verified: Dec 2016
First submitted: 17 Sep 2009
Last updated: 30 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.

Publications

Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta(2) agonist, vilanterol, in persistent asthma: a randomised trial. Respir Med. 2012 Aug;106(8):1110-5. doi: 10.1016/j.rmed.2012.03.007. Epub 2012 Apr 19.
PubMed 22520084

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

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Five Period Cross-over Study to Evaluate the Efficacy and Safety of Selected Doses and Dose Intervals of GW642444 Administered Via a Novel Dry Powder Inhaler (NDPI) in Subjects ≥18 Years of Age With Persistent Asthma
ClinicalTrials.gov ID: NCT00980200
Acronym / sponsor ID: 113310
Conditions: Asthma
Keywords: GW642444, once daily dosing, asthma, efficacy, safety, FEV1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 18 Sep 2009 (estimated)
Results: Posted 7 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

Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
C/E/A/B/D	Experimental	Drug: Dose 2 QDGW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD
D/C/E/A/B	Experimental	Drug: Dose 3 QDGW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD
A/B/C/D/E	Experimental	Drug: placeboplacebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD
B/A/D/E/C	Experimental	Drug: Dose 1 BDGW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD
E/D/B/C/A	Experimental	Drug: Dose 4 QDGW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo

Who may qualify

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

Key inclusion criteria (8 listed)

Outpatient
≥18 years of age at Visit 1
Male or Eligible Female
Diagnosis of asthma at least 12 weeks prior to Visit 1
Disease reversibility

Key exclusion criteria (8 listed)

History of Life-Threatening Asthma
No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
History of severe milk protein allergy

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
Dose 4 QDQD once daily	Drug	E/D/B/C/A
Dose 3 QDQD once daily	Drug	D/C/E/A/B
placeboplacebo	Drug	A/B/C/D/E
Dose 2 QDQD once daily	Drug	C/E/A/B/D
Dose 1 BDBD twice daily	Drug	B/A/D/E/C

Primary outcome

Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period
Time frame: Baseline and Day 7 of the treatment period (up to Study Day 63)
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.

1 secondary outcome

Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period
Time frame: Baseline and Day 7 of the treatment period (up to Study Day 63)

Results and safety

Results posted to the registry on 7 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: 6.25 µg BID, Pbo, 12.5 µg QD, 25 µg QD, 6.25 µg QD	15	15
Sequence 2: Pbo, 6.25 µg BID, 6.25 µg QD, 12.5 µg QD, 25 µg QD	14	13
Sequence 3: 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID, 12.5 µg QD	15	15
Sequence 4: 12.5 µg QD, 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID	16	16
Sequence 5: 25 µg QD, 12.5 µg QD, 6.25 µg BID, 6.25 µg QD, Pbo	15	15

Primary outcome: Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period

Time frame: Baseline and Day 7 of the treatment period (up to Study Day 63). Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 74	GW642444 6.25 µg QD n = 73	GW642444 6.25 µg BID n = 74	GW642444 12.5 µg QD n = 73	GW642444 25 µg QD n = 73
Value	0.059 (0.0221)	0.153 (0.0222)	0.198 (0.0221)	0.161 (0.0221)	0.184 (0.0221)

Placebo vs GW642444 6.25 µg QD: Mean Difference (Final Values): 0.094 (95% CI 0.049 to 0.140), p <0.001, ANCOVA
Placebo vs GW642444 6.25 µg BID: Mean Difference (Final Values): 0.140 (95% CI 0.095 to 0.185), p <0.001, ANCOVA
Placebo vs GW642444 12.5 µg QD: Mean Difference (Final Values): 0.102 (95% CI 0.057 to 0.147), p <0.001, ANCOVA

Population analysed: Intent-to Treat (ITT) Population: all participants randomized to treatment who received at least one dose of trial medication. Randomized participants were assumed to have received trial medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were analyzed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from randomization until follow-up (up to Day 70).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 74 (0%)	1 of 74 (1.4%)	Not reported
GW642444 6.25 µg QD	0 of 73 (0%)	0 of 73 (0%)	Not reported
GW642444 6.25 µg BID	0 of 74 (0%)	3 of 74 (4.1%)	Not reported
GW642444 12.5 µg QD	0 of 73 (0%)	0 of 73 (0%)	Not reported
GW642444 25 µg QD	0 of 73 (0%)	3 of 73 (4.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22520084Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B. Efficacy and optimal dosing interval of the long-acting beta(2) agonist, vilanterol, in persistent asthma: a randomised trial. Respir Med. 2012 Aug;106(8):1110-5. doi: 10.1016/j.rmed.2012.03.007. Epub 2012 Apr 19.
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.

Related trials for Asthma

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dose 4 QD, Dose 3 QD and Dose 2 QD in people with Asthma, run by GlaxoSmithKline at 9 sites in United States.

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 8 inclusion and 8 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 30 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 9 sites in United States. 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 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 7 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?

Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period (time frame: Baseline and Day 7 of the treatment period (up to Study Day 63)). 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 NCT00980200, 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 30 Jan 2017.