AsthmaPhase 2NCT00600171
Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.
A Phase 2 study testing GW642444M in people with Asthma, run by GlaxoSmithKline at 89 sites in 16 countries.
Trial summary
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- GW642444M
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 614 participants
- Where
- 89 sitesin 16 countries
- Study dates
- Dec 2007to Sep 2008
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 12 years of age or older at Visit 1 For sites in the following countries, subjects recruited will be ³ 18 years of age: Germany, Hungary and the Russian Federation and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only.
- Male or eligible female subjects
- A female is eligible to enter and participate in the study if she is of:
- Non-child bearing potential (i.e. physiologically incapable of becoming pregnant), including any female who is post-menopausal.
- Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
- Complete abstinence from intercourse from screening until 2 weeks after the follow-up contact; or
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- Sterilisation of male partner (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
- Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
- Injectable progestogen administered for at least 1 month prior to study medication administration and administered for 1 month following study completion; or
- Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
- Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) N.B. For German sites female subjects must use a method of birth control other than the double barrier method
- An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
- Estrogenic vaginal ring inserted for at least 1 month prior to study medication administration; or
- Percutaneous contraceptive patches in place for at least 1 month prior to study medication administration Female subjects should not be enrolled if they are pregnant, or lactating, or plan to become pregnant during the time of study participation.
- Documented clinical history of persistent asthma, as defined by the National Institutes of Health [NIH, 2007] first diagnosed at least 6 months prior to Visit 1.
- Subjects with current reversible airways disease as demonstrated at Visit 1 by an increase in FEV1 of ≥ 12% and ≥ 200ml over the pre-salbutamol/albuterol FEV1 at approximately 30 minutes after the inhalation of 400mcg of salbutamol/albuterol via MDI (spacer permitted for reversibility testing only if required) or one nebulised salbutamol/albuterol solution.
- Subjects must be using an inhaled corticosteroid and have been maintained on a stable dose for 4 weeks prior to Visit 1 at one of the following doses:
- Maximum Allowable Concurrent Inhaled Corticosteroid Doses
- Asthma Therapy(Maximum Daily Dose (mcg/day)) fluticasone propionate MDI CFC/HFA (≤ 880mcg1/ ≤1000mcg2) fluticasone propionate DPI(≤ 1000mcg) beclomethasone dipropionate(≤ 1680mcg1/ ≤ 2000mcg2) beclomethasone dipropionate HFA (QVAR)(≤ 640mcg1/ ≤ 800mcg2) budesonide DPI/MDI(≤ 2000mcg) Flunisolide(≤ 2000mcg) triamcinolone acetonide(≤ 2000mcg) mometasone furoate(≤ 880mcg) Ciclesonide(≤ 320mcg1/ ≤ 400mcg2)
- CFC=chlorofluorocarbon HFA=hydrofluoroalkane
- Ex-actuator dose
- Ex-valve dose
- Pre-bronchodilator FEV1 between ≥ 40 - ≤ 90% predicted at Visit 1. NHANES III predicted values will be used for subjects aged ≥ 12 years and adjustments to predicted values will be made for African American subjects [Hankinson, 1999].
- Appropriately signed and dated informed consent has been obtained.
- Capable of withholding salbutamol/albuterol use for ≥ 6 hours prior to clinic visits.
- In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Who cannot join
- An exacerbation of asthma within 4 weeks of Visit 1, or a culture documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks of Visit 1 that led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- Asthma exacerbation requiring treatment with oral corticosteroids within 3 months prior to Visit 1.
- Hospitalised for an asthma exacerbation within 6 months of Visit 1. Hospitalisation is defined as an overnight stay in a hospital.
- Previously enrolled in this study, or has participated in any study using an investigational drug during the previous 30 days or will participate simultaneously in another clinical trial.
- A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the subject's safety at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
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- The list of additional excluded conditions/diseases includes, but is not limited to the following:
- congestive heart failure, known aortic aneurysm clinically significant coronary heart disease, clinically significant cardiac arrhythmia stroke within 3 months of Visit 1, uncontrolled hypertension1 poorly controlled peptic ulcer, haematologic, hepatic, or renal disease immunologic compromise, current malignancy2 tuberculosis (current or untreated3), Cushing's disease Addison's disease, uncontrolled diabetes mellitus uncontrolled thyroid disorder, recent history of drug or alcohol abuse neurological disease, pulmonary disease4
- systolic blood pressure 160, or diastolic blood pressure >100
- history of malignancy is acceptable only if subject has been in remission for one year prior to Visit 1 (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to Visit 1)
- Subjects with a history of tuberculosis who have received an approved prophylactic treatment regimen or an approved active treatment regimen and who have no evidence of active disease for a minimum of 2 years may be enrolled [American Thoracic Society Documents, 2005] [American Thoracic Society (ATS), 2003]
- Including but not limited to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease.
- Any adverse reaction including immediate or delayed hypersensitivity to any ß2-agonist or sympathomimetic drug, or known (i.e., patients with a history of severe milk protein allergy) or suspected sensitivity to the constituents of GW642444M inhalation powder (e.g., lactose or magnesium stearate).
- Subjects who are likely to be non-compliant with study medication and other study-related requirements (e.g. attendance at clinic visits or completion of Daily Diary).
- Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol requirements.
- Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). The number of units of alcohol in a drink can be determined by multiplying the volume of the drink (in millilitres) by its percentage ABV and dividing by 1000
- Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years). A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco).
- Administration of systemic, oral or depot corticosteroids or administration of anti-IgE (e.g. omalizumab [Xolair]) within 12 weeks of Visit 1.
- Administration of the following asthma medications within 14 days of Visit 1:
- Theophyllines
- Oral β2-agonists (e.g. bambuterol)
- Slow-release bronchodilators
- Anticholinergics - short or long-acting
- Oral long acting antihistamines
- Oral leukotriene receptor antagonists (e.g. montelukast)
Trial locations and contacts
89 sites in 16 countries.
89 sites in 16 countries
United States30 sites
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Knoxville, Tennessee, 37909
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Providence, Rhode Island, 02909
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
River Forest, Illinois, 60305
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
Skillman, New Jersey, 08558
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Valrico, Florida, 33596
Canada8 sites
GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Mississauga, Ontario, L4W 1N2
GSK Investigational Site
Mississauga, Ontario, L5A 3V4
GSK Investigational Site
Montreal, Quebec, H3H 2R9
GSK Investigational Site
Montreal, Quebec, H4W 1S7
GSK Investigational Site
Québec, Quebec, G1V 4M6
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1
Germany8 sites
GSK Investigational Site
Berlin, State of Berlin, 14057
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562
GSK Investigational Site
Wiesbaden, Hesse, 65187
GSK Investigational Site
Wiesloch, Baden-Wurttemberg, 69168
Russia7 sites
GSK Investigational Site
Kazan', 420015
GSK Investigational Site
Moscow, 115446
GSK Investigational Site
Moscow, 117292
GSK Investigational Site
Ryazan, 390039
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Saratov, 410002
GSK Investigational Site
Yaroslavl, 150003
Argentina5 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425
GSK Investigational Site
Buenos Aires, Buenos Aires, 1437
GSK Investigational Site
La Plata, Buenos Aires, CP1900
GSK Investigational Site
Mendoza, Mendoza Province, M5500CCG
GSK Investigational Site
San Miguel de Tucumán, 4000
Poland5 sites
GSK Investigational Site
Bialystok, 15-025
GSK Investigational Site
Bydgoszcz, 85-168
GSK Investigational Site
Krakow, 31-023
GSK Investigational Site
Lodz, 91-348
GSK Investigational Site
Lodz, 93-504
South Africa5 sites
GSK Investigational Site
Cape Town, Gauteng, 7505
GSK Investigational Site
Cape Town, 7500
GSK Investigational Site
Claremont, 7708
GSK Investigational Site
eManzimtoti, 4126
GSK Investigational Site
Mowbray, 7700
France3 sites
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Paris, 75018
GSK Investigational Site
Toulouse, 31059
Netherlands3 sites
GSK Investigational Site
Harderwijk, 3844 DG
GSK Investigational Site
Heerlen, 6419 PC
GSK Investigational Site
Utrecht, 3584 CJ
Peru3 sites
GSK Investigational Site
Lima, Lima Province, Lima 1
GSK Investigational Site
Lima, Lima Province, Lima 27
GSK Investigational Site
Lima, Lima 11
Belgium2 sites
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Liège, 4000
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500551
GSK Investigational Site
Santiago, 8380453
Philippines2 sites
GSK Investigational Site
Cavite, 4114
GSK Investigational Site
Manila, 1000
South Korea2 sites
GSK Investigational Site
Cheongju, Chungcheongbuk-do, 361-711
GSK Investigational Site
Suwon, 443-721
Sweden2 sites
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Lund, SE-221 85
Thailand2 sites
GSK Investigational Site
Chiang Mai, 50200
GSK Investigational Site
Khon Kaen, 40002
About this study
Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Dose Ranging Study Evaluating the Efficacy and Safety of GW642444M Administered Once Daily Compared With Placebo for 28 Days in Adolescent and Adult Subjects With Persistent Asthma
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma
- Conditions
- Asthma
- Being tested
- GW642444M, Placebo
- Keywords
- dose ranging, placebo, asthma, safety, efficacy, pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW642444MDrug
GW642444M
PlaceboDrug
Placebo mulit-dose dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Multi dose dry powder inhlaer Receives: Drug: Placebo |
| GW642444M | Experimental | GW642444M Receives: Drug: GW642444M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])
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 clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
Measured: Baseline and Day 28
Secondary outcomes (9)
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)
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 clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline in trough FEV1 at the end of the treatment period (23 hours and 24 hours after dosing on Day 28) was analyzed for each stratum (Lower stratum: FEV1 percent predicted, >=40% to <=65%; Upper stratum: FEV1 percent predicted, >=65% to <=90%). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, treatment, and treatment by stratum interaction.
Measured: Baseline and Day 28
Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Change from Baseline in weighted mean for 24-hour serial FEV1 on Days 1 and Day 28 was assessed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
Measured: Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)
Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period
Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily PM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Measured: Baseline and Days 1-28
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period
Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily AM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Measured: Baseline and Days 1-28
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period
Participants who were symptom free for 24 hours were assessed. Change from Baseline was calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Measured: Baseline and Days 1-28
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period
The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. Change from Baseline is calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.
Measured: Baseline and Days 1-28
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28
Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), >=24 hours after the first dose (Visit 2) or last dose (Visit 5) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Measured: 24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5)
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1
Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Measured: Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2)
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28
Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.
Measured: Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 2008
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600171
- Sponsor's protocol ID
- B2C109575
- Status last verified
- Nov 2016
- First submitted
- 11 Jan 2008
- Last updated
- 16 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Lotvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B. 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J. 2012 Sep;40(3):570-9. doi: 10.1183/09031936.00121411. Epub 2012 Feb 23.
PubMed 22362859
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled, Parallel Group, Dose Ranging Study Evaluating the Efficacy and Safety of GW642444M Administered Once Daily Compared With Placebo for 28 Days in Adolescent and Adult Subjects With Persistent Asthma
- ClinicalTrials.gov ID
- NCT00600171
- Acronym / sponsor ID
- B2C109575
- Conditions
- Asthma
- Keywords
- dose ranging, placebo, asthma, safety, efficacy, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Posted 12 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Multi dose dry powder inhlaer |
| GW642444M | Experimental | Drug: GW642444MGW642444M |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Aged 12 years of age or older at Visit 1 For sites in the following countries, subjects recruited will be ³ 18 years of age: Germany, Hungary and the Russian Federation and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only.
- Male or eligible female subjects
- Non-child bearing potential (i.e. physiologically incapable of becoming pregnant), including any female who is post-menopausal.
- Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
- Complete abstinence from intercourse from screening until 2 weeks after the follow-up contact; or
Key exclusion criteria (25 listed)
- An exacerbation of asthma within 4 weeks of Visit 1, or a culture documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks of Visit 1 that led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- Asthma exacerbation requiring treatment with oral corticosteroids within 3 months prior to Visit 1.
- Hospitalised for an asthma exacerbation within 6 months of Visit 1. Hospitalisation is defined as an overnight stay in a hospital.
- Previously enrolled in this study, or has participated in any study using an investigational drug during the previous 30 days or will participate simultaneously in another clinical trial.
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 |
|---|---|---|
| GW642444MGW642444M | Drug | GW642444M |
| PlaceboPlacebo mulit-dose dry powder inhaler | Drug | Placebo |
Primary outcome
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])
Time frame: Baseline and Day 28
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 clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.
9 secondary outcomes
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)
Time frame: Baseline and Day 28
Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28
Time frame: Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)
Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period
Time frame: Baseline and Days 1-28
Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period
Time frame: Baseline and Days 1-28
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period
Time frame: Baseline and Days 1-28
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period
Time frame: Baseline and Days 1-28
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28
Time frame: 24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5)
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1
Time frame: Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2)
Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28
Time frame: Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22362859Lotvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B. 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J. 2012 Sep;40(3):570-9. doi: 10.1183/09031936.00121411. Epub 2012 Feb 23.
- 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
89 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW642444M in people with Asthma, run by GlaxoSmithKline at 89 sites in 16 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 26 inclusion and 25 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Canada, Germany, Russia, Argentina and 11 more countries. 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 12 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?
Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF]) (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600171, 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 16 Dec 2016.