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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg

CT thorax

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, NEXThaler®, Formoterol, Beclomethasone Dipropionate, Computational Fluid Dynamics, Functional Imaging, Central and Peripheral Airways, Asthma Control Test (ACT™), Asthma Control Questionnaire (ACQ)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients treated with extra-fine ICS either alone or with LABA
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
Inability to carry out pulmonary function testing
History of near fatal asthma
Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
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
Cancer
Current alcohol or drug abuse
Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
Patients treated with any non-permitted concomitant medication

Sites / Locations

University Hospital of Antwerp

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

beclomethasone dipropionate + formoterol fumarate

Arm Description

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).

Outcomes

Primary Outcome Measures

Computational Fluid Dynamics (CFD)

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

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

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

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.)

Full Information

NCT ID

NCT01650441

First Posted

June 29, 2012

Last Updated

May 27, 2015

Sponsor

University Hospital, Antwerp

Collaborators

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01650441

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Antwerp

Collaborators

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, NEXThaler®, Formoterol, Beclomethasone Dipropionate, Computational Fluid Dynamics, Functional Imaging, Central and Peripheral Airways, Asthma Control Test (ACT™), Asthma Control Questionnaire (ACQ)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

beclomethasone dipropionate + formoterol fumarate

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg

Other Intervention Name(s)

NEXThaler®

Intervention Description

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).

Intervention Type

Radiation

Intervention Name(s)

CT thorax

Intervention Description

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.

Primary Outcome Measure Information:

Title

Computational Fluid Dynamics (CFD)

Description

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).

Secondary Outcome Measure Information:

Title

Lung function tests

Description

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).

Title

Asthma Control

Description

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).

Title

Safety

Description

Time Frame

The safety of the NEXThaler® device will be monitored for the duration of the study, an expected average of 24 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Male or female patients aged ≥18 years Patients with a documented diagnosis of asthma according to the GINA guidelines Patients with a co-operative attitude and ability to be trained to correctly use the Foster NEXThaler DPI Written informed consent obtained Exclusion Criteria: Patients treated with extra-fine ICS either alone or with LABA 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 Inability to carry out pulmonary function testing History of near fatal asthma Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks 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 Cancer Current alcohol or drug abuse Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study Patients who received any investigational new drug within the last 4 weeks prior to the screening visit Patients treated with any non-permitted concomitant medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilfried A De Backer, MD PhD

Organizational Affiliation

University Hospital of Antwerp

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Antwerp

City

Edegem (Antwerp)

State/Province

Antwerp

ZIP/Postal Code

B-2650

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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