Clareo Health | Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
Patients with Forced Expiratory Volume in 1 sec (FEV1) \>= 70 % of predicted values
Non or ex-smokers
Body Mass Index (BMI) \>= 18.5 and \<= 32 kg/m2
You may not be if
Pregnant or lactating women unless using acceptable methods of contraception
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
History of near fatal asthma
Patients with abnormal QTcF at screening Visit
Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
History of drug addiction or excessive use of alcohol ;
Diagnosis of restrictive lung disease.
Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
Significant medical history or any laboratory abnormality indicative of a significant underlying condition
