Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02227394
• Date of registration: 25/08/2014
• Prospective Registration: No
• Primary sponsor: Zambon SpA
• Public title: Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients
• Scientific title: A Double Blind, Double Dummy, Randomized, Two Way Cross-over Study to Compare the Effects of Z7200 and Symbicort® Turbohaler on Functional Respiratory Imaging Parameters in Asthmatic Patients.
• Date of first enrolment: August 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02227394
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Wilfried De Backer, MD, PhD
• Affiliation: University Hospital, Antwerp

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma Bronchial

Asthma

Asthma Chronic

Asthmatic

Intervention(s)

Drug: Placebo of Test product

Drug: Z7200

Drug: Symbicort® Turbohaler®

Drug: Placebo of Reference Drug

Radiation: Functional Respiratory Imaging

Primary Outcome(s)

Total airway volume (iVaw) [Time Frame: Up to 3 months]

The number of deposited particles per pre-defined airway section [Time Frame: Up to 3 months]

Total Airway Resistance (iRaw) [Time Frame: Up to 3 months]

Secondary Outcome(s)

Body plethysmography [Time Frame: Up to 3 months]

Inhalation profile [Time Frame: Up to 3 months]

Lung function tests: Spirometry parameters [Time Frame: Up to 3 months]

VAS [Time Frame: Up to 3 months]

6MWT [Time Frame: Up to 3 months]

Borg CR10 Scale [Time Frame: Up to 3 months]

Secondary ID(s)

Z7200K02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FLUIDDA nv