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

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ClinicalTrials.gov Identifier: NCT02227394
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : December 17, 2014
Sponsor:
Collaborator:
FLUIDDA nv
Information provided by (Responsible Party):
Zambon SpA

Brief Summary:

This study will be 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, will be included.

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).The secondary objectives of this study are to assess the effect of 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.


Condition or disease Intervention/treatment Phase
Asthma Asthma Chronic Asthma Bronchial Asthmatic Drug: Z7200 Drug: Symbicort® Turbohaler® Drug: Placebo of Test product Drug: Placebo of Reference Drug Radiation: Functional Respiratory Imaging Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Experimental: Z7200

Z7200 is contained in single dose capsules (HPMC) and it is administered through a single dose dry powder inhaler (DPI), that is structurally correspondent to Aerolizer/Cyclohaler device.

Strength: Each delivered dose contains budesonide 80 mcg/inhalation and formoterol fumarate dihydrate 2.25 mcg/inhalation; two inhalations (i.e. total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01) provided.

Drug: Z7200

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)

Other Name: Test product

Drug: Placebo of Reference Drug

Single dose of 2 puffs

Symbicort placebo does not contain any drug substances, (Budesonide and Formoterol fumarate), or excipients (Lactose monohydrate).

At visit 2 or 3 (cross-over)

To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Other Name: Placebo of Symbicort® Turbohaler®

Radiation: Functional Respiratory Imaging
CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose.

Active Comparator: Symbicort® Turbohaler
Symbicort® Turbohaler® inhalation powder; AstraZeneca UK Limited. Budesonide and formoterol fumarate dihydrate concentration Strength: Each delivered dose contains budesonide 160 mcg/inhalation and formoterol fumarate dihydrate 4.5 mcg/inhalation; two inhalations (i.e. total dose budesonide/formoterol is 320 mcg/9 mcg).
Drug: Symbicort® Turbohaler®
Total dose budesonide/formoterol is 320 mcg/9 mcg. At visit 2 or 3 (cross-over design)
Other Name: Reference product

Drug: Placebo of Test product

Single dose of 2 puffs

Z7200 inhalation powder placebo is filled in size 3 hydroxypropyl methylcellulose (HPMC) capsules.

At visit 2 or 3 (cross-over)

To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Other Name: Placebo of Z7200

Radiation: Functional Respiratory Imaging
CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose.




Primary Outcome Measures :
  1. Total airway volume (iVaw) [ Time Frame: Up to 3 months ]
    The primary objective of this study is to evaluate the effect of Z7200 and Symbicort® on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD).

  2. The number of deposited particles per pre-defined airway section [ Time Frame: Up to 3 months ]
    The primary objective of this study is to evaluate the effect of Z7200 and Symbicort® on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD).

  3. Total Airway Resistance (iRaw) [ Time Frame: Up to 3 months ]
    The primary objective of this study is to evaluate the effect of Z7200 and Symbicort® on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD).


Secondary Outcome Measures :
  1. Lung function tests: Spirometry parameters [ Time Frame: Up to 3 months ]

    Spirometry parameters - Lung function:

    1. Forced Expiratory Volume in one second (FEV1),
    2. Forced Vital Capacity (FVC),
    3. Peak Expiratory Flow (PEF),
    4. Maximum Expiratory Flow at 25% of FVC (MEF25),
    5. Maximum Expiratory Flow at 50% of FVC (MEF50),
    6. Tiffeneau Index (FEV1/FVC ratio)

  2. Body plethysmography [ Time Frame: Up to 3 months ]

    Body plethysmography:

    1. Functional Residual Capacity (FRC),
    2. Total Lung Capacity (TLC)
    3. Airway resistance: Airway Resistance (Raw), Specific airway resistance (SRaw)

  3. Inhalation profile [ Time Frame: Up to 3 months ]
    Inhalation profile with respiration belt: Inspiration Volume (IV)

  4. 6MWT [ Time Frame: Up to 3 months ]
    6MWT: Exercise capacity: distance walked in 6 minutes (m)

  5. Borg CR10 Scale [ Time Frame: Up to 3 months ]
    Borg category (C) ratio (R) 10 scale: measure of the present dyspnoea

  6. VAS [ Time Frame: Up to 3 months ]
    VAS: measure of the difference in dyspnoea before and after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227394


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Zambon SpA
FLUIDDA nv
Investigators
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Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
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Responsible Party: Zambon SpA
ClinicalTrials.gov Identifier: NCT02227394    
Other Study ID Numbers: Z7200K02
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014
Keywords provided by Zambon SpA:
Asthma
Functional Respiratory Imaging
Computational Fluid Dynamic
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents