Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
FLUIDDA nv
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patient ≥ 18 years old
Written informed consent obtained
Patient with a documented diagnosis of asthma according to the GINA guidelines
Patient with a co-operative attitude and ability to be trained to correctly use the pMDI
Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
Patient must be stable and treated in accordance with the GINA guidelines
Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 year prior to visit 1 and has a smoking history of \< 10 pack years
Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions
You may not be if
Pregnant or lactating female
Unstable patient who developed an exacerbation during the last 8 weeks
Patient with upper or lower airways infection
Patient unable to carry out pulmonary function testing
Patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
Patient with cancer or any other chronic disease with poor prognosis and /or affecting patient status
Patient with allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
Patient who received oral corticosteroids within the last 4 weeks prior to visit 1
Patient who received any investigational new drug within the last 4 weeks prior to visit 1 or twice the duration of the biological effect of any drug (whichever is longer)
Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
Patient who has undergone major surgery in the last 12 weeks before the visit 1 or has planned to undergo a major surgery before the end of the trial
Patient with diagnosis of chronic obstructive pulmonary disease (COPD)
Clareo Health | Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients
