Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .
Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Outpatient
≥18 years of age at Visit 1
Male or Eligible Female
Diagnosis of asthma at least 12 weeks prior to Visit 1
Disease reversibility
Current anti-asthma therapy
Appropriately signed and dated informed consent has been obtained
Able to comply with all the study requirements
You may not be if
History of Life-Threatening Asthma
No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
History of severe milk protein allergy
Non-compliance with study medication and other study-related requirements
No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol
Clareo Health | Efficacy and Safety Study in Subjects With Asthma
