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Clinical Trials/PER-024-08
PER-024-08
Completed
未知

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

GLAXOSMITHKLINE PERU S.A.,0 sites0 target enrollmentApril 8, 2008
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Conditions-J45J45

Overview

Phase
未知
Intervention
Not specified
Conditions
-J45
Sponsor
GLAXOSMITHKLINE PERU S.A.,
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 8, 2008
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
GLAXOSMITHKLINE PERU S.A.,

Eligibility Criteria

Inclusion Criteria

  • •Must be 12 years of age or older in Visit 1\. For centers in the following countries, subjects who join must be\> 18 years of age: Germany, Hungary and the Russian Federation, and any other country where the regulations local or the regulatory status of study medication allow the incorporation of adults only.
  • •Be male or meet the requirements in the case of female subjects A female subject is eligible to enter and participate in the study if: Has no reproductive potential (ie, is physiologically unable to get pregnant), including women postmenopausal It has reproductive potential; a pregnancy test has been performed on the screening with a negative result, and accepts one of the following acceptable contraceptive methods used in a consistent and correct manner (ie according to the approved product leaflet and the doctor´s instructions for the duration of the study) from the selection to the follow\-up contact). Female subjects should not be included if they are pregnant, breastfeeding or if they intend to become pregnant during their participation in the study.
  • •Documented clinical history of persistent asthma, defined by the National Institutes of Health \[NIH, 2007] with a first diagnosis at least 6 months before Visit 1\.
  • •Subjects with current reversible airway disease, as demonstrated in Visit 1 through an increase in FEVi of 12% and 200ml on FEV1 prior to salbumatol / albuterol in approximately 30 minutes after inhaling 400mcg of salbutamol / albuterol through MDI (the inhalation chamber is allowed for the reversibility test only if necessary) or a nebulized salbutamol / albuterol solution.
  • •Subjects should use an inhaled corticosteroid that has been maintained at a stable dose for 4 weeks prior to Visit 1
  • •FEV1 before the bronchodilator of between 40 \- 90% predicted in Visit 1\. The predicted values of NHANES in will be used for subjects of 12 years of age and adjustments will be made to the predicted values in the case of African\-American subjects \[Hankinson , 1999].
  • •Appropriately signed and dated informed consent has been obtained.
  • •Is able to interrupt the use of salbutamol / albuterol for 6 hours prior to clinical visits.
  • •In France, a subject will be eligible for inclusion in the study only if he or she is a member or beneficiary of a social security category.

Exclusion Criteria

  • •An asthma exacerbation within 4 weeks of Visit 1, or a bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear infection documented by culture or suspected, within 4 weeks of Visit 1 that leads to a change in the management of asthma, or in the opinion of the researcher is expected to affect the status of the subject´s asthma or the subject´s ability to participate in the study.
  • •History of asthma that presents a threat to life, defined as an episode of asthma that required intubation and / or was associated with hypercapnia, respiratory arrest or hypoxic convulsions.
  • •Exacerbation of asthma requiring treatment with oral eprticosteroids within 3 months prior to Visit 1\.
  • •Hospitalization due to asthma exacerbation within 6 months of the visit. 1\. Hospitalization refers to the overnight stay in the hospital.
  • •Has been previously included in this study, or has participated in any study with a research drug in the previous 30 days, or will participate simultaneously in another clinical study.
  • •A subject should not present any uncontrolled clinically significant disease or condition that, in the opinion of the investigator, could jeopardize the subject´s safety through participation in the study or could confuse the interpretation of efficacy results if the condition or illness will be exacerbated during the study.
  • •Any adverse reaction, including immediate or delayed hypersensitivity to any p2\-agonist or sympathomimetic drug, or known sensitivity (eg, patients with a history of severe allergy to milk protein) or suspected inhalation powder components GW642444M (ie, lactose or magnesium stearate).
  • •Subjects presenting a probability of noncompliance with study medication and other study requirements (such as attendance at clinical visits or completion of the daily record).
  • •Neurological or psychiatric disorders or a history of drug or alcohol abuse that could interfere with the subject´s ability to meet the requirements stipulated by the protocol.
  • •Alcohol abuse is defined as the average weekly consumption of more than 21 units or the average daily consumption of more than 3 units (men) or the average weekly consumption of more than 14 units or the average daily consumption of more than 2 units (women). The amount of alcohol units in a beverage can be determined by multiplying the volume of the beverage (in milliliters) by its percentage ABV and dividing by 1000

Outcomes

Primary Outcomes

Not specified

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