Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
12–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Type of Subject: Outpatient
Age: ≥12 years of age
Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
Asthma Diagnosis: As defined by NIH
Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio \>0.70
Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
QTC: QTc(F)\<450msec or QTc(F)\<480 for subjects with Bundle Branch Block
Liver function: Normal liver function
Informed Consent
You may not be if
History of Life-threatening asthma: Within previous 5 years
Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
