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

NCT01650441 | Completed Phase 2

• 2 other identifiers: PML_DOC_11022011-003249-16
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (3)

• 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).

• 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).

• Safety

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

Study Arms (1)

beclomethasone dipropionate + formoterol fumarate

EXPERIMENTAL

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; Radiation: CT thorax

Interventions

Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg DRUG

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).

Also known as: NEXThaler®

beclomethasone dipropionate + formoterol fumarate

CT thorax RADIATION

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.

beclomethasone dipropionate + formoterol fumarate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (1)

University Hospital of Antwerp

Edegem (Antwerp), Antwerp, B-2650, Belgium

Location

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Wilfried A De Backer, MD PhD

  University Hospital of Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 26, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

BE (1)