Study to Assess the Effect of the NEXThaler® Device (DPI - Dry Powder Inhaler) on the Central and Peripheral Airway Dimensions in Asthmatic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01650441
First received: June 29, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate in a dry powder inhaler (NEXThaler®) on central and peripheral airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will be used. Further more, the effect of this combination therapy on lung function (spirometry, resistance and diffusion), the Asthma Control Test (ACT™) and the Asthma Control Questionnaire (ACQ) will be assessed and the safety will be evaluated.


Condition Intervention Phase
Asthma
Drug: Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg
Radiation: CT thorax
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OPEN-LABEL, PROSPECTIVE EXPLORATORY STUDY TO ASSESS THE EFFECTS OF FORMOTEROL AND BECLOMETASONE DIPROPIONATE COMBINATION THERAPY USING A DPI DEVICE ON CENTRAL AND PERIPHERAL AIRWAY DIMENSIONS IN ASTHMATIC PATIENTS.

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Computational Fluid Dynamics (CFD) [ Time Frame: CFD will be performed based on the images of 2 CT thorax scans in a dose reduction protocol (1 CT Thorax taken at baseline and 1 CT Thorax taken after 6 months of treatment with the NEXThaler® device). ] [ Designated as safety issue: No ]

    The parameters that will be obtained with the CFD based imaging and used as primary outcome parameters are:

    • Total airway resistance for the segmented airways iRtot
    • Peripheral airway resistance(from 4th bifurcation on) for the segmented airways iRperph
    • Total airway volume for the segmented airways (iVtot)
    • Peripheral airway volume (from the 4th bifurcation on) for the segmented airways (iVperiph)
    • Relative compliance for each lobe (iClobe-rel)
    • Density of the lung parenchyma given per predefined lung zone (Ldens)


Secondary Outcome Measures:
  • Lung function tests [ Time Frame: Lung function tests will be performed at screening (visit 1), after 2 week run-in period both pre and post dose (visit 2), after 3 months treatment (visit 5), after 6 months treatment both pre and post dose (visit 8). ] [ Designated as safety issue: No ]

    The parameters that will be obtained with the described lung function tests are:

    • Dynamic lung volumes: FEV1, FVC, PEF, MEF75, MEF50, MEF25
    • Static lung volumes: VC, IVC, FRC, TLC
    • Airway resistances: Raw, SGaw

  • Asthma Control [ Time Frame: Asthma control will be monitored at screening (visit 1), after 2 week run-in period (visit 2), after 3 months treatment (visit 5), after 6 months treatment (visit 8). ] [ Designated as safety issue: No ]
    Asthma Control will be monitored during the study using 2 different questionnaires: the Asthma Control Test (ACT™) and the Asthma Control Questionnaire (ACQ, both the 6-items and the 7-items test will be used.)

  • Safety [ Time Frame: The safety of the NEXThaler® device will be monitored for the duration of the study, an expected average of 24 weeks. ] [ Designated as safety issue: Yes ]
    During the study the patient will be told to record each day taken medication and any possible comments on the daily diary cards, starting from visit 1. Further more, the patient will be contacted at least once a month (either by phone or a visit in the hospital.)


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: beclomethasone dipropionate + formoterol fumarate
All patients will be treated with the active product. No placebo arm will be used. The active product is a fixed combination containing extra-fine beclometasone dipropionate and formoterol fumarate in a new dry powder inhaler device, NEXThaler® (Chiesi Farmaceutici, Parma, Italy).
Drug: Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg
In this trial, patients will take two inhalations of the beclometasone dipropionate 100 µg and formoterol fumarate 6 µg combination therapy (Foster®) using a Dry Powder Inhaler (NEXThaler®) device in the morning and two inhalations in the evening, for a total of 4 inhalations a day (total daily dose: BDP 400 µg / FF 24 µg).
Other Name: NEXThaler®
Radiation: CT thorax

CT scan of the thorax will be performed at 2 time points: baseline and after 6 months of treatment.

The CT scan will be performed with low dose radiation using the multi-slice CT scan. Scanning will be performed at Functional Residual Capacity and Total Lung Capacity (2 times 8 sec). The lung volumes will be controlled using adapted spirometry during the CT procedure. The radiation dose will be reduced by reduction of the tube current and voltage. These settings depend on the patients' weight (1mAs/kg). In addition to this there will be an increase in noise factor to further reduce the radiation dose.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with moderate asthma as defined by the current GINA guidelines. Patients can belong to 2 categories:

    Group 1 (n=15 to 20, at least 4 current smokers): Patients not well controlled (partially controlled or uncontrolled according to the GINA guidelines) when using medium daily dose of ICS or medium dose ICS + long acting inhaled 2-agonists (LABA) (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).

    Group 2 (n=15 to 20, at least 4 current smokers ): Patients well controlled (according to GINA guidelines) when using medium daily dose of ICS + LABA (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).

  2. Male or female patients aged ≥18 years
  3. Patients with a documented diagnosis of asthma according to the GINA guidelines
  4. Patients with a co-operative attitude and ability to be trained to correctly use the Foster NEXThaler DPI
  5. Written informed consent obtained

Exclusion Criteria:

  1. Patients treated with extra-fine ICS either alone or with LABA
  2. Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period
  3. Inability to carry out pulmonary function testing
  4. History of near fatal asthma
  5. Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
  6. Patients 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. Cancer
  8. Current alcohol or drug abuse
  9. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
  10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
  11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
  12. Patients treated with any non-permitted concomitant medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650441

Locations
Belgium
University Hospital of Antwerp
Edegem (Antwerp), Antwerp, Belgium, B-2650
Sponsors and Collaborators
University Hospital, Antwerp
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Wilfried A De Backer, MD PhD University Hospital of Antwerp
  More Information

No publications provided

Responsible Party: Wilfried De Backer, MD PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01650441     History of Changes
Other Study ID Numbers: PML_DOC_1102, 2011-003249-16
Study First Received: June 29, 2012
Last Updated: June 18, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
Asthma
NEXThaler®
Formoterol
Beclomethasone Dipropionate
Computational Fluid Dynamics
Functional Imaging
Central and Peripheral Airways
Asthma Control Test (ACT™)
Asthma Control Questionnaire (ACQ)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Formoterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014