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

NCT ID: NCT01650441

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg

Intervention Type: 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).

CT thorax

Intervention Type: 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.

Interventions

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).

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

NEXThaler®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Wilfried De Backer

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wilfried A De Backer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Antwerp

Locations

University Hospital of Antwerp

Edegem (Antwerp), Antwerp, Belgium

Countries

Belgium

Other Identifiers

2011-003249-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PML_DOC_1102

Identifier Type: -

Identifier Source: org_study_id