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AsthmaPhase 2NCT00398645

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Persistent Asthma.

A Phase 2 study testing GW685698X 200mcg,GW685698X 200mcg and 400mcg in people with Asthma, run by GlaxoSmithKline at 82 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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?
GW685698X 200mcg,GW685698X 200mcg and 400mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
648 participants
Where
82 sitesin 16 countries
Study dates
15 Nov 2006to 30 Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Type of Subject: Outpatient
  • Age: 12 years of age or older at Visit 1 (or ³18 years of age or older if local regulations or the regulatory status of study medication permit enrollment of adults only).
  • Gender: Male or eligible female - Females are eligible to participate only if they are currently non-pregnant and non-lactating. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, Implants of levonorgestrel, Injectable progestogen, Oral contraceptive (either combined estrogen/progestin or progestin only), Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, Double-barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm), The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds), Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test is required for all subjects at all visits, Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test is required for all subjects at all visits, Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test is required for all subjects at all visits, Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days),
  • Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National Institutes of Health, 2002; GINA, 2005].
  • Severity of Disease: A best AM FEV1 of 50% to 80% of the predicted value during Visit 1 based on the "Standardization of Lung Function Tests" [European Respiratory Society, 1993] standards for 18 years and older or Polgar [Polgar, 1971] standards for 12 to 17 years and race adjusted for African-Americans [American Thoracic Society, 1991].
  • Reversibility of Disease: Demonstrated ³12% and 200mL reversibility of FEV1 within 30 minutes following 200 to 400mcg of albuterol/salbutamol inhalation aerosol (or one nebulized albuterol/salbutamol treatment) at Visit 1. If a subject fails to demonstrate an increase in FEV1 of ³12% and 200mL, the subject is not eligible for the study and will not be allowed to re-screen.
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  • Concurrent Anti-Asthma Therapy: Subjects must be using an inhaled corticosteroid for at least 3 months prior to Visit 1 and be maintained on a stable dose for four weeks prior to Visit 1 at one of the following doses: Anti-Asthma Therapy Maximum Daily Dose (mcg/day) Fluticasone propionate MDI CFC/HFA ≤220mcg1/≥250mcg2 Fluticasone propionate DPI 200mcg Beclomethasone dipropionate 420mcg1/500mcg2 Beclomethasone dipropionate HFA 160mcg1/200mcg2 Budesonide DPI 400mcg Flunisolide 1000mcg Triamcinolone acetonide 1000mcg Mometasone furoate 200mcg Ciclesonide 160mcg1/200mcg2
  • Ex-actuator dose: dose delivered to the lungs
  • Ex-valve dose: dose expressed from the valve
  • Short-Acting Beta2-Agonist: All subjects must be able to replace short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as-needed for the duration of the study. Subjects must be able to withhold all inhaled short-acting beta-sympathomimetic bronchodilators for at least 6 hours prior to study visits.Note: Nebulized albuterol/salbutamol will not be allowed during the study with the exception of its use during reversibility testing at Visit 1. The use of albuterol/salbutamol through the DISKUS/ACCUHALER device will not be allowed during the study.
  • Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study.
  • Compliance: Subjects must be able to comply with all the study requirements.

Who cannot join

  • History of Life-Threatening Asthma: History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
  • Anti-Asthma Medications: Asthma medications listed below must not have been used prior to Visit 1 for the required interval listed below, and not taken during the study: Within 24 hours of Visit 1: Oral short-acting beta2-agonists: Within 2 weeks of Visit 1:Combination therapy containing inhaled beta2-agonists and ICS for asthma (e.g., fluticasone propionate/salmeterol combination, budesonide/formoterol combination);Slow-release bronchodilators (e.g., aminophylline, theophylline);Anticholinergics; Long-acting beta2-agonists (e.g., salmeterol); Ketotifen; Nedocromil sodium; Sodium cromoglycate; Oral long-acting beta2-agonists. Within 4 weeks of Visit 1: Anti-leukotrienes including suppressors of leukotriene production and antagonists. Within 12 weeks of Visit 1: Systemic, oral, parenteral, or depot corticosteroids; Anti-IgE (e.g., omalizumab).
  • Other Medications: The medications listed below must not have been used prior to Visit 1 for the required interval indicated below, and not taken during the study: Within 4 weeks of Visit 1: Known potent inhibitors of CYP3A4 (e.g., ritonavir, ketoconazole)
  • Respiratory Infection: History of a respiratory tract infection within 4 weeks of Visit 1. In addition, the subject must be excluded, if such infection occurs between Visits 1 and 2.
  • Asthma Exacerbation: History of a an asthma exacerbation within 4 weeks of Visit 1, any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1, or any hospitalization due to asthma exacerbation within 6 months of Visit 1.
  • Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 1 or within ten half-lives (t1/2) of the prior investigational study (which ever is longer of the two) or concurrently during the study.
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  • Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has evidence of oropharyngeal candidiasis at Visit 1.
  • Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy.
  • Milk Protein Allergy: History of severe milk protein allergy.
  • Immunosuppressive Medications: A subject must not be using, or require use of, immunosuppressive medications during the study.
  • Note: Immunotherapy for the treatment of allergies is allowed during the study provided that it was initiated prior to Visit 1 and the subject is maintained on a stable daily dose throughout the study period.
  • Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol or scheduled visits to the study center and compliance with study medication or procedures (e.g., 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 excludes study participation.
  • Tobacco Use: A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco) and must not have historical use of >10 pack years (e.g., 20 cigarettes/day for 10 years).
  • Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.

Trial locations and contacts

82 sites in 16 countries.

82 sites in 16 countries

United States16 sites

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    El Paso, Texas, 79925

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Lake Oswego, Oregon, 97035

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33143

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Sylvania, Ohio, 43560

Other trials in United States

Russia8 sites

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Irkutsk, 664005

  • GSK Investigational Site

    Kazan', 420015

  • GSK Investigational Site

    Moscow, 115 280

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Australia7 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Clayton, Victoria, 3168

  • GSK Investigational Site

    Concord, New South Wales, 2139

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Toorak Gardens, South Australia, 5065

Other trials in Australia

Ukraine7 sites

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Kiev, 01004

  • GSK Investigational Site

    Kiev, 01601

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 02091

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Vinnitsa, 21021

Other trials in Ukraine

Bulgaria5 sites

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Varna, 9010

  • GSK Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Germany5 sites

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 13597

  • GSK Investigational Site

    Kassel, Hesse, 34117

  • GSK Investigational Site

    Marburg, Hesse, 35037

Other trials in Germany

Mexico5 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44340

  • GSK Investigational Site

    México, 04530

  • GSK Investigational Site

    México, 6720

  • GSK Investigational Site

    Monterrey, Nuevo León, 64020

  • GSK Investigational Site

    Monterrey, Nuevo León, 64460

Other trials in Mexico

South Africa5 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Bloemfontein, 9300

  • GSK Investigational Site

    Cape Town, 7925

  • GSK Investigational Site

    eManzimtoti, 4126

  • GSK Investigational Site

    Newtown, 2113

Other trials in South Africa

Chile4 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500551

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500691

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

Israel4 sites

  • GSK Investigational Site

    Ashkelon, 78360

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Rehovot, 76100

Other trials in Israel

Canada3 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Woodstock, Ontario, N4S 4G3

Other trials in Canada

Peru3 sites

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    Lima, Lima 27

  • GSK Investigational Site

    San Isidro, Lima region, Lima 27

Other trials in Peru

Philippines3 sites

  • GSK Investigational Site

    Cebu, 6000

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Quezon City, 1101

Other trials in Philippines

Thailand3 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Khon Kaen, 40002

Other trials in Thailand

Croatia2 sites

  • GSK Investigational Site

    Split, 21000

  • GSK Investigational Site

    Zagreb, 10000

Other trials in Croatia

New Zealand2 sites

  • GSK Investigational Site

    Tauranga, 3001

  • GSK Investigational Site

    Wellington, 6035

Other trials in New Zealand

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of GW685698X 200 mcg Twice Daily, GW685698X 200 mcg and 400 mcg Once Daily in the Morning, and GW685698X 200 mcg and 400 mcg Once Daily in the Evening Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects (12 Years of Age and Older) With Persistent Asthma

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Read the detailed description

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of GW685698X 200mcg Twice Daily, GW685698X 200mcg and 400mcg Once Daily in the Morning, and GW685698X 200mcg and 400mcg Once Daily in the Evening Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects (12 Years of Age and Older) with Persistent Asthma.

Conditions
Asthma
Being tested
GW685698X 200mcg,GW685698X 200mcg and 400mcg
Keywords
GW685698X, Adults, Pharmacokinetics, Pharmacogenetics, Asthma, Adolescents
Medical subject headings
Asthma

What participants receive

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

  • GW685698X 200mcg,GW685698X 200mcg and 400mcgDrug

    Also called GW685698X 200mcg, GW685698X 200mcg and 400mcg

Study groups in NCT00398645
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: GW685698X 200mcg,GW685698X 200mcg and 400mcg

What is being measured

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

  1. The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)

Timeline

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

  1. First posted14 Nov 2006 (estimated)
  2. Study start15 Nov 2006
  3. Primary completion1 Aug 2007
  4. Study completion30 Aug 2007

Resources

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
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398645
Sponsor's protocol ID
FFA106783
Status last verified
Jan 2018
First submitted
9 Nov 2006
Last updated
23 Jan 2018
Results posted
No
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

  • Woodcock A, Bateman ED, Busse WW, Lotvall J, Snowise NG, Forth R, Jacques L, Haumann B, Bleecker ER. Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial. Respir Res. 2011 Oct 6;12(1):132. doi: 10.1186/1465-9921-12-132.

    PubMed 21977941

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW685698X 200mcg,GW685698X 200mcg and 400mcg in people with Asthma, run by GlaxoSmithKline at 82 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 12 inclusion and 15 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Russia, Australia, Ukraine, Bulgaria 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. 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?

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

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1). 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 NCT00398645, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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