Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients
Condition: Asthma; Asthma Chronic; Asthma Bronchial; Asthmatic
MeSH terms: Asthma
Intervention: Z7200; Symbicort® Turbohaler®
Intervention description: Total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01).
At visit 2 or 3 (cross-over design); Total dose budesonide/formoterol is 320 mcg/9 mcg. At visit 2 or 3 (cross-over design)
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Functional Respiratory Imaging; Computational Fluid Dynamic

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 with Computational fluid dynamics (CFD).

      Secondary Objectives:

      The secondary objectives of this study were to assess the effect of test product and
      reference product on:

        -  lung function (spirometry and body plethysmography),

        -  exercise capacity (6-Minute Walking Test [6MWT] or equivalent method to measure exercise
           tolerance),

        -  dyspnea (Borg Category [C] Ratio [R] 10 [Borg CR10] scale and Visual Analogue Scale
           [VAS] dyspnea).

      Furthermore, the safety of the test product and reference product was evaluated through
      monitoring of AEs throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          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.

        Exclusion Criteria:

          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.