Study to compare the effects of Z7200 And Symbicort® Turbohaler on respiratory imaging parameters in asthmatic patients.
- Conditions
- AsthmaMedDRA version: 17.0Level: LLTClassification code 10049106Term: Asthma chronicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 17.0Level: LLTClassification code 10003565Term: AsthmaticSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 17.0Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-002151-26-BE
- Lead Sponsor
- Zambon Spa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female patient = 18 years old.
2. Written informed consent obtained.
3. Patient with a documented diagnosis of asthma according to the
Global Initiative for Asthma (GINA) guidelines
4. Patient with a co-operative attitude and ability to correctly use the DPI.
5. 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)
6. Patient must be stable and treated in accordance with the GINA guidelines.
7. 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.
8. Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Pregnant or lactating female.
2. Unstable patient who developed an asthma exacerbation in the 4 weeks before screening.
3. Patient with upper or lower airways infection in the 4 weeks before screening.
4. Patient unable to perform pulmonary function testing.
5. Patients unable to withdraw fixed combination or long acting bronchodilator inhalation products
6. 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.
7. Patient with active lung cancer or any other chronic disease with poor prognosis and /or affecting patient status.
8. Patient with allergy, sensitivity or intolerance to study drugs and/ or study drug formulation ingredients.
9. Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
10. Patient who received systemic corticosteroids within the last 4 weeks prior to visit
11. Patient who received any investigational new drug within the last 4 weeks prior to visit 1 and is participating in any clinical trial.
12. Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
13. Patient with diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
14. Patients who has a lactose intolerance or history of allergy to milk proteins.
15. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the effect of the<br>products under investigation on Functional respiratory imaging<br>parameters and evaluate the particle deposition with Computational fluid dynamics (CFD).;Secondary Objective: The secondary objectives of this study are to assess the effect of<br>Z7200 and Symbicort® on lung function (spirometry and body plethysmography), on exercise capacity (6MWT)and on dyspnea (Borg CR10 Scale and VAS dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events throughout the study;Primary end point(s): The parameters that will be obtained with Computational fluid dynamics<br>(CFD) and used as primary outcome parameters are:<br>- Total airway volume and total airway resistance<br>- The number of deposited particles per pre-defined airway section;Timepoint(s) of evaluation of this end point: December 2014
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary outcome variables that will be obtained with respective tests<br>are listed below:<br>Spirometry/ Lung function :<br>- Forced Expiratory volume in 1 sec (FEV1),<br>- Forced Vital Capacity (FVC),<br>- Peak Expiratory Flow (PEF),<br>- Maximum Expiratory Flow at 25% of FVC (MEF50),<br>- Maximum Expiratory Flow at 50% of FVC (MEF25),<br>- Inspiratory Vital Capacity (IVC),<br>- Tiffeneau Index (FEV1/FVC ratio)<br>Bodyplethysmography<br>- Functional Residual Capacity (FRC),<br>- Total Lung Capacity (TLC),<br>- Airway resistance: Airway Resistance (Raw), Specific airway<br>conductance (SGaw)<br>6 Minute Walk Test<br>- Exercise capacity: distance walked in 6 minutes (m)<br>Borg CR10 Scale: measure of the present dyspnea<br>Visual Analog Scale: measure of the difference in dyspnea before and<br>after treatment;Timepoint(s) of evaluation of this end point: December 2014