Functional Respiratory Imaging Study (FRI)

NCT03268226 | Completed Phase 3

• 2 other identifiers: CCD-05993AA1-162017-000438-79
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the effect of inhaled extrafine CHF5993 pMDI on airway volumes, and resistance, by Functional Respiratory Imaging (FRI), in COPD patients

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Specific image-based airway volumes (siVaw)

  CT-based airway volumes normalized by the lung volume

  Change from baseline at 24 Weeks.

• Specific image-based airway resistance (siRaw)

  CFD-based airway resistance normalized by the lung volume

  Change from baseline at 24 Weeks.

Secondary Outcomes (14)

• Internal Airflow Distribution

  On Week 0, Week 12, and on Week 24

• Air Trapping

  On Week 0, Week 12, and on Week 24

• Emphysema

  On Week 0, Week 12, and on Week 24

• Airway Wall Volume

  On Week 0, Week 12, and on Week 24

• Blood vessel density

  On Week 0, Week 12, and on Week 24

Other Outcomes (1)

• exercise tolerance

  On Week 0, Week 12, and on Week 24

Study Arms (1)

CHF5993

EXPERIMENTAL

Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide administered via pMDI

Drug: Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium

Interventions

Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium DRUG

An inhaled dose of CHF 5993 pMDI 100+6+12.5 μg twice a day (Total daily dose: BDP 400 μg / FF 24 μg / GB 50 μg)

CHF5993

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject's written informed consent obtained prior to any study-related procedure.
• Male or Female COPD patients aged ≥ 40 years.
• Smoking history: of at least 10 pack-years (pack-year= number of cigarettes per day x number of years/20).
• Smoking status: current or ex-smokers. Previous smokers are defined as those who have stopped smoking for at least 24 weeks prior to screening visit. (Pipe and/or cigar and/or e-cigarettes smoking cannot be used to calculate pack-year history). If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to study entry.
• Patients with documented COPD at least 12 months according to GOLD 2017.
• Post-bronchodilator (BD) decreased Tiffeneau index: FEV1/FVC \< 0.70.
• Patients who present post- BD FEV1 less than 50 % of predicted.
• Patients who present (Functional residual capacity) FRC ≥120% predicted.
• Patients who present CAT assessment ≥10.
• Patients on stable respiratory medications for at least 3 months prior to screening with non extrafine extemporary triple combination. The possible combination therapies prior to screening are:
• fluticasone plus salmeterol plus tiotropium
• fluticasone plus salmeterol plus glycopyrronium
• fluticasone plus salmeterol plus umeclidinium
• fluticasone plus vilanterol plus tiotropium
• fluticasone plus vilanterol plus glycopyrronium

You may not qualify if:

• Pregnant or lactating women.
• Patients with history or current diagnosis of asthma.
• Medical history or current diagnosis of allergic rhinitis or atopy (atopy which may have risen contra-indications or impacted the efficacy of the study treatment according to Investigator's judgment).
• Patients requiring use of the following medications:
• Systemic steroids for COPD exacerbation in the 4 weeks prior to screening;
• Patients with a moderate or severe COPD exacerbation \[i.e. resulting in the use of systemic corticosteroids (oral/IV/IM) and/or or antibiotics or need for hospitalisation within 6 weeks prior to screening\];
• A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening;
• c-Phosphodiesterase-4 (PDE-4) inhibitors in the 4 weeks prior to screening;
• Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) in the 4 weeks prior to screening;
• Patients treated with non-cardio-selective β-blockers in the week prior to screening.
• Patients treated with long-acting anti-histamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study.
• Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
• Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according the Investigator's judgment. (This could include but is not limited to α-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease).
• Lung cancer or history of lung cancer: patients with a diagnosis of lung cancer or a history of lung cancer.
• Lung resection: subjects with a history of lung volume resection.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (5)

SGS CPU Antwerpen

Antwerp, Belgium

Location

AZ Saint-Maarten

Duffel, Belgium

Location

Centre medical Erpent - Residence

Erpent, Belgium

Location

Heilige Familie AZ

Reet, Belgium

Location

National Koranyi Institute for TB and Pulmonology

Budapest, Hungary

Location

Related Links

• Study Record on EU Clinical Trials Register including results.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 31, 2017
• Study Start: November 20, 2017
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); HU (1)