Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.

NCT ID: NCT00600171

Last Updated: 2016-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 614 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-09-30

Brief Summary

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

Conditions

Asthma

Keywords

dose ranging; placebo; asthma; safety; efficacy; pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo Multi dose dry powder inhlaer

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo mulit-dose dry powder inhaler

GW642444M

GW642444M

Group Type: EXPERIMENTAL

GW642444M

Intervention Type: DRUG

GW642444M

Interventions

GW642444M

GW642444M

Intervention Type: DRUG

Placebo

Placebo mulit-dose dry powder inhaler

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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

1. Ex-actuator dose

2. 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.

Exclusion Criteria

• 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.

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

1. systolic blood pressure 160, or diastolic blood pressure >100

2. 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)

3. 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]

4. 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)

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Tallahassee, Florida, United States

GSK Investigational Site

Valrico, Florida, United States

GSK Investigational Site

Coeur d'Alene, Idaho, United States

GSK Investigational Site

River Forest, Illinois, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Sunset, Louisiana, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

North Dartmouth, Massachusetts, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

Rolla, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Skillman, New Jersey, United States

GSK Investigational Site

The Bronx, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Providence, Rhode Island, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Knoxville, Tennessee, United States

GSK Investigational Site

Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Plata, Buenos Aires, Argentina

GSK Investigational Site

Mendoza, Mendoza Province, Argentina

GSK Investigational Site

San Miguel de Tucumán, , Argentina

GSK Investigational Site

Edegem, , Belgium

GSK Investigational Site

Liège, , Belgium

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Mississauga, Ontario, Canada

GSK Investigational Site

Mississauga, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Sainte-Foy, Quebec, Canada

GSK Investigational Site

Trois-Rivières, Quebec, Canada

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Toulouse, , France

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Wiesloch, Baden-Wurttemberg, Germany

GSK Investigational Site

Rüdersdorf, Brandenburg, Germany

GSK Investigational Site

Wiesbaden, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Geesthacht, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Harderwijk, , Netherlands

GSK Investigational Site

Heerlen, , Netherlands

GSK Investigational Site

Utrecht, , Netherlands

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Lima, Lima Province, Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Cavite, , Philippines

GSK Investigational Site

Manila, , Philippines

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Kazan', , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Ryazan, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saratov, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Cape Town, Gauteng, South Africa

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Claremont, , South Africa

GSK Investigational Site

eManzimtoti, , South Africa

GSK Investigational Site

Mowbray, , South Africa

GSK Investigational Site

Cheongju, Chungcheongbuk-do, , South Korea

GSK Investigational Site

Suwon, , South Korea

GSK Investigational Site

Gothenburg, , Sweden

GSK Investigational Site

Lund, , Sweden

GSK Investigational Site

Chiang Mai, , Thailand

GSK Investigational Site

Khon Kaen, , Thailand

Countries

United States; Argentina; Belgium; Canada; Chile; France; Germany; Netherlands; Peru; Philippines; Poland; Russia; South Africa; South Korea; Sweden; Thailand

References

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.

Reference Type: BACKGROUND

PMID: 22362859 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

B2C109575

Identifier Type: -

Identifier Source: org_study_id