A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are currently using non-ICS controller medications. Subjects will participate in the study for up to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment sequence.

A sub-group of subjects at selected sites (approximately 30% of the total population) will have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic sampling at the start and end of each treatment period. Safety assessments will include monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic analysis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Written informed consent

• Outpatient (sub-group will have 3 overnight stays at clinic)

• Diagnosis of asthma (NIH 2007) for at least 6 months

• Male or Eligible female (females of child-bearing potential must use acceptable method of birth control)

• A best AM pre-bronchodilator FEV1 of 60% to 85% of predicted normal value at Screening

• Reversibility of disease demonstrated by at least 12% and 200mL increase in FEV1 .

• Subjects must have been prescribed a non-corticosteroid controller at least 3 months preceding Visit 1, and/or a short-acting beta 2 agonist, without the use of inhaled corticosteroids in the 4 weeks prior to Visit 1

• Subjects must be able to replace their current short-acting Beta-2-agonist with albuterol/salbutamol aerosol inhaler for the duration of the study

• Subjects must be judged capable of withholding albuterol/salbutamol for at least 4 hours prior to study visits

Exclusion Criteria:

• History of life threatening asthma

• Severe asthma exacerbation

• Respiratory infection within expected to affect subject's ability to participate

• Concurrent respiratory disease

• Current smoker or smoking history of 10 pack years or more

• Diseases preventing use of anticholinergics

• Other clinically significant, uncontrolled condition or disease which would pose a safety risk to the patient, or confound interpretation of study results

• Drug allergy to any Beta-2-agonist, sympathomimetic drug, intranasal, inhaled or systemic corticosteroid therapy

• Known or suspected sensitivity to the constituents of the Novel DPI (ie lactose)

• History of severe milk protein allergy

• Administration of prescription or over-the-counter medication that would significantly affect the course of asthma, or interact with the study drug

• Any infirmity, disability or disease of a child or family member likely to impair compliance

• Alcohol or substance abuse history

• Viral hepatitis B surface antigen or Hepatitis C antibody

• Known HIV-positive history.

• Affiliation with investigator or site staff