Status:
COMPLETED
Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients
Lead Sponsor:
Zambon SpA
Collaborating Sponsors:
FLUIDDA nv
Conditions:
Asthma
Asthma Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective: The primary objective of this study is to evaluate the effect of the products under investigation on functional respiratory imaging parameters and evaluate the particle deposition ...
Detailed Description
This study is conducted as a randomized, double blind, double dummy two-period crossover study in stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines. ...
Eligibility Criteria
Inclusion
- Male or female patient ≥ 18 years old.
- Written informed consent obtained.
- Patient with a documented diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines
- Patient with a co-operative attitude and ability to correctly use the DPI.
- Female patient of childbearing potential who confirm that a reliable method of contraception was used at least 14 days before visit 1 and will continue to use a reliable method of contraception during the study, or post-menopausal women (at least 12 months of amenorrhea)
- 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 month 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.
Exclusion
- Pregnant or lactating female.
- Unstable patient who developed an asthma exacerbation in the 4 weeks before screening.
- Patient with upper or lower airways infection in the 4 weeks before screening.
- Patient unable to perform pulmonary function testing.
- Patients unable to withdraw fixed combination or long acting bronchodilator inhalation products
- 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 active lung 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 systemic corticosteroids within the last 4 weeks prior to visit
- Patient who received any investigational new drug within the last 4 weeks prior to visit 1 and is participating in any clinical trial.
- Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
- Patient with diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- Patients who has a lactose intolerance or history of allergy to milk proteins.
- Patients treated with medications or herbal medicines that are strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, ketoconazole, itraconazole, voriconazole, fluconazole, cyclosporine, mibefradil, nefazodone, clarithromycin, telithromycin, troleandromycin, norfloxacin, ciprofloxacin) or inducers (e.g. phenobarbital, phenytoin, barbiturates, carbamazepine, oxcarbazepine, rifabutin, rifampin, St John's wort) within 2 weeks prior to Screening Visit and during the study.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02227394
Start Date
August 1 2014
End Date
November 1 2014
Last Update
January 27 2022
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650