Persistent Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: GW642444 Inhalation Powder Predispensed
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: GW642444M
Current Spons
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1 Aged 12 years of age or older at Visit 1 For sites in the following countries, subjects recruited will be = 18 years of age: Germany, Hungary, the Russian Federation and France and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only. 2 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. 3 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. 4 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
Exclusion criteria
Exclusion criteria: 1 Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear and/or exacerbation of asthma within 4 weeks of Visit 1. 2 History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures. 3 Asthma exacerbation requiring treatment with oral corticosteroids within 3 months prior to Visit 1. 4 Hospitalised for an asthma exacerbation within 6 months of Visit 1. Hospitalisation is defined as an overnight stay in a hospital. 5 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. 6 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:Please see section 4.3.6 of the exclusion criteria within protocol. 7 Any adverse reaction including immediate or delayed hypersensitivity to any ß2-agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444M inhalation powder (i.e. lactose or magnesium stearate). 8 Subjects who are likely to be non-compliant with study medication and other studyrelated requirements (e.g. attendance at clinic visits or completion of Daily Diary). 9 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 10 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). 11 Administration of systemic, oral or depot corticosteroids or administration of anti-IgE (e.g. omalizumab [Xolair]) within 12 weeks of Visit 1. 12 Administration of any of the following asthma medications within 14 days of Visit 1: Please see section 4.3.12 of the exclusion within the protocol. 13 Administration of inhaled long-acting ß2-agonists (e.g. salmeterol) within 7 days of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose response, efficacy and safety of five doses of GW642444M (3mcg, 6.25mcg, 12.5mcg, 25mcg and 50mcg) over a 28 day treatment period in subjects with persistent asthma.; Secondary Objective: To characterise the population pharmacokinetics of GW642444 in subjects with persistent asthma ; Primary end point(s): Mean change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period. The trough FEV1 will be defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. | — |
Countries
Belgium, France, Germany, Netherlands, Poland, Sweden
Outcome results
None listed