Functional Respiratory Imaging Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2022-01-03

Brief Summary

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The purpose of this study is to evaluate the stepping-up effect from a double ICS/LABA DPI therapy to a triple DPI therapy on airway geometry and lung ventilation

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CHF5993

Beclometasone Dipropionate (BDP) 100 μg/inhalation + Formoterol Fumarate (FF) 6 μg/inhalation + Glycopyrronium Bromide (GB) 12.5 µg/inhalation

Group Type EXPERIMENTAL

Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium

Intervention Type DRUG

Two inhalations bid: 4 inhalations; total daily dose of 400/24/50 μg BDP/FF/GB

Interventions

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Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium

Two inhalations bid: 4 inhalations; total daily dose of 400/24/50 μg BDP/FF/GB

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject's signed Informed Consent Form;
2. Male or female ≥ 40 years of age;
3. Current smokers or ex-smokers of at least 10 pack-years,
4. Established diagnosis of COPD
5. Post-BD Forced Expiratory Volume in one second/Forced Vital Capacity (FEV1/FVC) \< 0.7 and FEV1 ≤ 60% of predicted at V1
6. On a stable dose any non-extra fine ICS/LABA DPI twice daily regimen for at least 8 weeks before screening;
7. Presence of lung hyperinflation
8. Symptomatic subjects with COPD assessment test (CAT) score ≥ 10;
9. Documented history of ≥ 1 moderate or severe COPD exacerbation in the previous 12 months

Exclusion Criteria

1. Pregnant or lactating woman;
2. Exacerbations defined as a sustained and acute deterioration of subject's symptoms and signs 30 days before screening;
3. A current asthma diagnosis;
4. Respiratory disorders other than COPD:
5. Cardiovascular diseases;
6. Evidence or history of other concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease;
7. Medical history or current diagnosis of narrow-angle glaucoma;
8. History of lung transplant or lung reduction surgery;
9. ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the subjects at risk;
10. Laboratory abnormalities;
11. Alcohol/drug abuse;
12. Contra-indications to Investigational medical products (IMPs), based on investigator judgement;
13. Documented Covid-19 diagnosis or its complications which have not resolved within 14 days prior to screening;

15\. Positive molecular Covid-19 test within the last 72 hours before the remaining of screening activities.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No