A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma
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
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
Outpatients of both sexes, aged \> 12 years
Moderate to severe symptomatic asthma
Forced expiratory volume in the first second (FEV1) \> 40% and \< 80% of the predicted normal values
Reversibility test
"Partly controlled" asthma (GINA revised 2006)
Patients free of long-acting beta2-agonists (LABAs) treatment
Under inhaled corticosteroids (ICS) treatment
A minimum inspiratory flow ≥ 40 L/min 10.
Non-smokers or ex smokers
Asthma Control Questionnaire ACQ score ≥ 1.5
You may not be if
Pregnant or nursing (lactating) women
Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
History of near fatal asthma
Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
Diagnosis COPD
History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
Diagnosis of restrictive lung disease
Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
Allergy to any component of the study treatments
Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
Patients with abnormal QTc
Clareo Health | A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma
