Functional Respiratory Imaging Study

  • STATUS
    Recruiting
  • End date
    Feb 2, 2022
  • participants needed
    30
  • sponsor
    Chiesi Farmaceutici S.p.A.
Updated on 2 August 2021

Summary

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

Details
Condition Chronic Obstructive Lung Disease, chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Treatment Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium
Clinical Study IdentifierNCT04876677
SponsorChiesi Farmaceutici S.p.A.
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Pregnant or lactating woman
Exacerbations defined as a sustained and acute deterioration of subject's symptoms and signs 30 days before screening
A current asthma diagnosis
Respiratory disorders other than COPD
Cardiovascular diseases
Evidence or history of other concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease
Medical history or current diagnosis of narrow-angle glaucoma
History of lung transplant or lung reduction surgery
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
Laboratory abnormalities
Alcohol/drug abuse
Contra-indications to Investigational medical products (IMPs), based on investigator judgement
Documented Covid-19 diagnosis or its complications which have not resolved within 14 days prior to screening
Positive molecular Covid-19 test within the last 72 hours before the remaining of screening activities
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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