CompletedNCT00766090Updated Dec 8, 2016Results posted

Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma

A Phase 2 interventional study of GW685698X in Asthma, sponsored by GlaxoSmithKline. Completed at 16 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2016-12-08.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 190
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study summary

The purpose of this study is to compare once and twice daily GW685698 in asthma

Conditions studied

Asthma

Browse trials for

Asthma 4,010

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 190 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

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Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Clinical diagnosis of Asthma
Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
FEV1 between 40-85% predicted
Currently on short acting beta2 agonist therapy

Key Exclusion Criteria:

History of life threatening asthma
Respiratory Infection or oropharyngeal candidiasis
Asthma exacerbation
Uncontrolled disease or clinical abnormality
Allergies
Taking another Investigational medications or other prohibited medications

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 190 participants (actual)

Study arms

Experimental
GW685698X
Drug: GW685698X

Interventions

DrugGW685698X
Inhaled Corticosteroid

What researchers measure

Primary outcomes

Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.
Time frame: Day 28 of the relevant treatment period (up to Study Day 112)

Secondary outcomes

Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold \>=3%) and SAEs.
Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.
Time frame: Day 28 of the relevant treatment period (up to Study Day 112)
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods
Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which \>=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.
Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal

Results

Posted Aug 7, 2013

Participant flow

Treatment Period 1 (28 Days)

Participant flow — Treatment Period 1 (28 Days)
Milestone	Sequence 1: Placebo, FF 200 µg, FF 100 µg	Sequence 2: Placebo, FF 100 µg, FF 200 µg	Sequence 3: FF 100 µg, Placebo, FF 200 µg	Sequence 4: FF 100 µg, FF 200 µg, Placebo	Sequence 5: FF 200 µg, Placebo, FF 100 µg	Sequence 6: FF 200 µg, FF 100 µg, Placebo	Sequence 7: Placebo, FP 200 µg, FP 100 µg	Sequence 8: Placebo, FP 100 µg, FP 200 µg	Sequence 9: FP 100 µg, Placebo, FP 200 µg	Sequence 10: FP 100 µg, FP 200 µg, Placebo	Sequence 11: FP 200 µg, Placebo, FP 100 µg	Sequence 12: FP 200 µg, FP 100 µg, Placebo
Started	25	27	23	26	23	23	6	8	7	8	7	7
Completed	22	27	23	25	23	23	6	8	6	8	7	7
Not completed	3	0	0	1	0	0	0	0	1	0	0	0
Withdrew: Lost to follow-up	0	0	0	0	0	0	0	0	1	0	0	0
Withdrew: Lack of efficacy	2	0	0	0	0	0	0	0	0	0	0	0
Withdrew: Withdrawal by subject	1	0	0	1	0	0	0	0	0	0	0	0

Washout Period 1 (14 Days)

Participant flow — Washout Period 1 (14 Days)
Milestone	Sequence 1: Placebo, FF 200 µg, FF 100 µg	Sequence 2: Placebo, FF 100 µg, FF 200 µg	Sequence 3: FF 100 µg, Placebo, FF 200 µg	Sequence 4: FF 100 µg, FF 200 µg, Placebo	Sequence 5: FF 200 µg, Placebo, FF 100 µg	Sequence 6: FF 200 µg, FF 100 µg, Placebo	Sequence 7: Placebo, FP 200 µg, FP 100 µg	Sequence 8: Placebo, FP 100 µg, FP 200 µg	Sequence 9: FP 100 µg, Placebo, FP 200 µg	Sequence 10: FP 100 µg, FP 200 µg, Placebo	Sequence 11: FP 200 µg, Placebo, FP 100 µg	Sequence 12: FP 200 µg, FP 100 µg, Placebo
Started	22	27	23	25	23	23	6	8	6	8	7	7
Completed	22	27	22	25	23	23	6	8	6	8	7	7
Not completed	0	0	1	0	0	0	0	0	0	0	0	0
Withdrew: Protocol violation	0	0	1	0	0	0	0	0	0	0	0	0

Treatment Period 2 (28 Days)

Participant flow — Treatment Period 2 (28 Days)
Milestone	Sequence 1: Placebo, FF 200 µg, FF 100 µg	Sequence 2: Placebo, FF 100 µg, FF 200 µg	Sequence 3: FF 100 µg, Placebo, FF 200 µg	Sequence 4: FF 100 µg, FF 200 µg, Placebo	Sequence 5: FF 200 µg, Placebo, FF 100 µg	Sequence 6: FF 200 µg, FF 100 µg, Placebo	Sequence 7: Placebo, FP 200 µg, FP 100 µg	Sequence 8: Placebo, FP 100 µg, FP 200 µg	Sequence 9: FP 100 µg, Placebo, FP 200 µg	Sequence 10: FP 100 µg, FP 200 µg, Placebo	Sequence 11: FP 200 µg, Placebo, FP 100 µg	Sequence 12: FP 200 µg, FP 100 µg, Placebo
Started	22	27	22	25	23	23	6	8	6	8	7	7
Completed	22	27	21	25	21	23	6	8	6	8	7	7
Not completed	0	0	1	0	2	0	0	0	0	0	0	0
Withdrew: Lost to follow-up	0	0	0	0	2	0	0	0	0	0	0	0
Withdrew: Lack of efficacy	0	0	1	0	0	0	0	0	0	0	0	0

Washout Period 2 (14 Days)

Participant flow — Washout Period 2 (14 Days)
Milestone	Sequence 1: Placebo, FF 200 µg, FF 100 µg	Sequence 2: Placebo, FF 100 µg, FF 200 µg	Sequence 3: FF 100 µg, Placebo, FF 200 µg	Sequence 4: FF 100 µg, FF 200 µg, Placebo	Sequence 5: FF 200 µg, Placebo, FF 100 µg	Sequence 6: FF 200 µg, FF 100 µg, Placebo	Sequence 7: Placebo, FP 200 µg, FP 100 µg	Sequence 8: Placebo, FP 100 µg, FP 200 µg	Sequence 9: FP 100 µg, Placebo, FP 200 µg	Sequence 10: FP 100 µg, FP 200 µg, Placebo	Sequence 11: FP 200 µg, Placebo, FP 100 µg	Sequence 12: FP 200 µg, FP 100 µg, Placebo
Started	22	27	21	25	21	23	6	8	6	8	7	7
Completed	22	27	20	25	21	23	6	8	6	8	7	7
Not completed	0	0	1	0	0	0	0	0	0	0	0	0
Withdrew: Physician decision	0	0	1	0	0	0	0	0	0	0	0	0

Treatment Period 3 (28 Days)

Participant flow — Treatment Period 3 (28 Days)
Milestone	Sequence 1: Placebo, FF 200 µg, FF 100 µg	Sequence 2: Placebo, FF 100 µg, FF 200 µg	Sequence 3: FF 100 µg, Placebo, FF 200 µg	Sequence 4: FF 100 µg, FF 200 µg, Placebo	Sequence 5: FF 200 µg, Placebo, FF 100 µg	Sequence 6: FF 200 µg, FF 100 µg, Placebo	Sequence 7: Placebo, FP 200 µg, FP 100 µg	Sequence 8: Placebo, FP 100 µg, FP 200 µg	Sequence 9: FP 100 µg, Placebo, FP 200 µg	Sequence 10: FP 100 µg, FP 200 µg, Placebo	Sequence 11: FP 200 µg, Placebo, FP 100 µg	Sequence 12: FP 200 µg, FP 100 µg, Placebo
Started	22	27	20	25	21	23	6	8	6	8	7	7
Completed	22	26	20	24	20	22	6	8	6	8	7	6
Not completed	0	1	0	1	1	1	0	0	0	0	0	1
Withdrew: Protocol violation	0	0	0	0	0	1	0	0	0	0	0	0
Withdrew: Lack of efficacy	0	1	0	1	0	0	0	0	0	0	0	1
Withdrew: Lost to follow-up	0	0	0	0	1	0	0	0	0	0	0	0

Outcome measures

PrimaryTrough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.

Time frame:: Day 28 of the relevant treatment period (up to Study Day 112)
Reported as:: Least squares mean · Liters

Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
Liters	Placebo	FF 200 µg OD	FF 100 µg BID	FP 200 µg OD	FP 100 µg BID
Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period	2.605 ± 0.0434	2.714 ± 0.0444	2.703 ± 0.0443	2.693 ± 0.0535	2.737 ± 0.0533

Statistical analysis

Placebo vs FF 200 µg OD · ANCOVA · p = <0.001 · Mean difference (final values): 0.108 · 95% CI 0.064 to 0.153
Placebo vs FF 100 µg BID · ANCOVA · p = <0.001 · Mean difference (final values): 0.098 · 95% CI 0.054 to 0.142
Placebo vs FP 200 µg OD · ANCOVA · p = 0.020 · Mean difference (final values): 0.087 · 95% CI 0.014 to 0.161
FF 200 µg OD vs FF 100 µg BID · ANCOVA · p = 0.641 · Mean difference (final values): 0.011 · 95% CI -0.035 to 0.056
Placebo vs FP 100 µg BID · ANCOVA · p = <0.001 · Mean difference (final values): 0.132 · 95% CI 0.059 to 0.205

SecondaryNumber of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods

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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold \>=3%) and SAEs.

Time frame:: From the first dose of the study medication up to Week 16/Early Withdrawal
Reported as:: Number · participants

Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
participants	Placebo	FF 200 µg OD	FF 100 µg BID	FP 200 µg OD	FP 100 µg BID
Any AE	26	22	26	2	3
Any SAE	0	0	0	0	0

Secondary24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period

A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.

Time frame:: Day 28 of the relevant treatment period (up to Study Day 112)
Reported as:: Geometric mean · Nanomoles per 24 hours

24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
Nanomoles per 24 hours	Placebo	FF 200 µg OD	FF 100 µg BID	FP 200 µg OD	FP 100 µg BID
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period	53.94 ± 66.423	40.25 ± 92.316	45.13 ± 87.181	56.16 ± 94.259	47.56 ± 84.896

SecondaryNumber of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period

Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.

Time frame:: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Reported as:: Number · participants

Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
participants	Placebo	FF 200 µg OD	FF 100 µg BID	FP 200 µg OD	FP 100 µg BID
Day 0: Yes, n=187, 140, 142, 42, 43	0	0	0	0	0
Day 0: No, n=187, 140, 142, 42, 43	187	140	142	42	43
Day 28: Yes, n=178, 139, 140, 42, 42	0	0	0	0	0
Day 28: No, n=178, 139, 140, 42, 42	178	139	140	42	42

SecondarySystolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.

Time frame:: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Reported as:: Mean · millimeters of mercury (mmHg)

Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
millimeters of mercury (mmHg)	Placebo	FF 200 µg OD	FF 100 µg BID	FP 200 µg OD	FP 100 µg BID
SBP: Day 0, n=187, 140, 142, 42, 43	120.1 ± 12.08	118.3 ± 11.96	119.5 ± 12.28	122.1 ± 13.55	121.3 ± 12.10
SBP: Day 28, n=178, 139, 140, 42, 42	119.6 ± 12.76	120.5 ± 13.31	120.6 ± 12.71	120.4 ± 11.92	120.1 ± 10.58
DBP: Day 0, n=187, 140, 142, 42, 43	75.8 ± 8.26	74.6 ± 7.69	76.0 ± 8.03	77.5 ± 9.98	76.6 ± 8.73
DBP: Day 28, n=178, 139, 140, 42, 42	75.8 ± 8.45	74.9 ± 8.12	76.4 ± 7.97	76.0 ± 7.81	75.7 ± 8.90

SecondaryHeart Rate at Day 0 and Day 28 of the Relevant Treatment Period

Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.

Time frame:: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Reported as:: Mean · beats per minute

Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
beats per minute	Placebo	FF 200 µg OD	FF 100 µg BID	FP 200 µg OD	FP 100 µg BID
Day 0, n=187, 140, 142, 42, 43	77.0 ± 9.53	76.4 ± 9.27	77.6 ± 8.71	74.5 ± 9.22	75.8 ± 8.12
Day 28, n=178, 139, 140, 42, 42	76.6 ± 8.79	76.9 ± 9.32	77.7 ± 9.47	74.7 ± 7.96	74.6 ± 8.49

SecondaryNumber of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods

Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which \>=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.

Time frame:: From the first dose of the study medication up to Week 16/Early Withdrawal
Reported as:: Number · participants

Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods
participants	FF 200 µg, FF 100 µg, and Placebo Via DPI	FP 200 µg, FP 100 µg, and Placebo Via DISKUS
Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods	5	1

Adverse events

Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	0/187 (0%)	2/187 (1.1%)
FF 200 µg OD	—	0/140 (0%)	7/140 (5%)
FF 100 µg BID	—	0/142 (0%)	7/142 (4.9%)
FP 200 µg OD	—	0/42 (0%)	0/42 (0%)
FP 100 µg BID	—	0/43 (0%)	0/43 (0%)

Most frequent other events

Most frequent other events
Event	Placebo	FF 200 µg OD	FF 100 µg BID	FP 200 µg OD	FP 100 µg BID
Upper respiratory tract infectionInfections and infestations	2/187	7/140	7/142	0/42	0/43

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	FF 200 µg, FF 100 µg, and Placebo Via DPI	FP 200 µg, FP 100 µg, and Placebo Via DISKUS	Total
Mean	31.4 ± 15.30	35.2 ± 16.03	32.3 ± 15.51

Gender
Gender(Participants)	FF 200 µg, FF 100 µg, and Placebo Via DPI	FP 200 µg, FP 100 µg, and Placebo Via DISKUS	Total
Female	87	21	108
Male	60	22	82

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	FF 200 µg, FF 100 µg, and Placebo Via DPI	FP 200 µg, FP 100 µg, and Placebo Via DISKUS	Total
African American/African Heritage (HER)	50	20	70
American Indian (AI) or Alaska Native (AN)	1	0	1
Japanese/East Asian HER/South East Asian HER	2	1	3
Native Hawaiian or other Pacific Islander	1	0	1
White	90	22	112
African American/African HER & AI or AN & White	1	0	1
African American/African Heritage & White	2	0	2

Study locations

16 sites

GSK Investigational Site
Long Beach, California 90806, United States
GSK Investigational Site
Long Beach, California 90808, United States
GSK Investigational Site
Torrance, California 90505, United States
GSK Investigational Site
Cocoa, Florida 32927, United States
GSK Investigational Site
Tallahassee, Florida 32308, United States
GSK Investigational Site
Bethesda, Maryland 20814, United States
GSK Investigational Site
Columbia, Missouri 65203, United States
GSK Investigational Site
Rolla, Missouri 65401, United States
GSK Investigational Site
Raleigh, North Carolina 27607, United States
GSK Investigational Site
Canton, Ohio 44718, United States
GSK Investigational Site
Medford, Oregon 97504, United States
GSK Investigational Site
Orangeburg, South Carolina 29118, United States
GSK Investigational Site
Austin, Texas 78750, United States
GSK Investigational Site
Boerne, Texas 78006, United States
GSK Investigational Site
San Antonio, Texas 78229, United States
GSK Investigational Site
Waco, Texas 76712, United States

References and documents

Publications

Woodcock A, Bleecker ER, Busse WW, Lotvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011 Dec 21;12(1):160. doi: 10.1186/1465-9921-12-160. PubMed 22188590 ↗
O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x. PubMed 27881132 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2008, a primary completion of Mar 2009 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2013, 4 years 5 months after primary completion. A results delay was requested in Feb 2010.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 2, 2008
First posted: Oct 3, 2008
Start: Oct 2008
Primary completionActual: Mar 2009
CompletionActual: Mar 2009
Results delay requested: Feb 5, 2010
Results first posted: Aug 7, 2013
Last update: Dec 8, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00766090
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Oct 3, 2008
Start date: Oct 2008
Primary completion: Mar 2009
Completion: Mar 2009
Results posted: Aug 7, 2013
Last update: Dec 8, 2016

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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