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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg; Radiation: CT thorax

• Registration Number: NCT01650441
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
beclomethasone dipropionate + formoterol fumarate	Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg	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).
beclomethasone dipropionate + formoterol fumarate	CT thorax	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).

Primary Outcome Measures

Name	Time	Method
Computational Fluid Dynamics (CFD)	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).	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

Name	Time	Method
Safety	The safety of the NEXThaler® device will be monitored for the duration of the study, an expected average of 24 weeks.	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.)
Lung function tests	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).	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 at screening (visit 1), after 2 week run-in period (visit 2), after 3 months treatment (visit 5), after 6 months treatment (visit 8).	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.)

Trial Locations

Locations (1)

University Hospital of Antwerp; 🇧🇪 Edegem (Antwerp), Antwerp, Belgium