Beclomethasone Dipropionate for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Obstructive Pulmonary Disease (COPD)+1 MoreBeclomethasone Dipropionate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether CHF 5993 is more effective than CHF 1535 at improving lung function, reducing exacerbations of COPD, and improving other clinical outcomes.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Chronic Obstructive Pulmonary Disease Exacerbation

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

52-week treatment period
Heart rate
Rate of severe COPD exacerbations over 52 weeks of treatment
Time to first moderate or severe COPD exacerbation
Time to first severe COPD exacerbation
Week 52
Change from baseline in 2-hour post-dose morning FVC at designated clinic visits
Change from pre-dose to 2-hour post-dose morning FEV1 at designated clinic visits
Change from pre-dose to 2-hour post-dose morning FVC at designated clinic visits
FEV1 response (change from baseline in pre-dose morning FEV1 ≥100ml) at designated clinic visits
Modified Medical Research Council (mMRC) dyspnea scale at designated clinic visits
Week 52
Change from baseline in 2-hour post-dose morning FEV1 designated clinic visits
Week 52
Change from baseline to each inter-visit period in the average E-RS total score and domain scores
Change from baseline to each inter-visit period in the average use of rescue medication (number of puffs/day)
Change from baseline to each inter-visit period in the percentage of days without intake of rescue medication
Week 28
Change from baseline in 2-hour post-dose morning FEV1 at Week 28
Change from baseline in pre-dose morning Forced Expiratory Volume in the 1st second (FEV1) at Week 28
Week 52
CAT response (decrease from baseline ≥2 points) at designated clinic visits
Change from baseline in COPD Assessment Test (CAT) score at designated clinic visit
Change from baseline in pre-dose morning Forced Vital Capacity (FVC) at designated clinic visits
Change from baseline in the SGRQ total score and domain scores at each designated clinic visit
Saint George's Respiratory Questionnaire (SGRQ) response (a decrease from baseline in total score ≥4) at designated clinic visits
Week 52
Change from baseline in pre-dose morning FEV1 at designated clinic visits

Trial Safety

Side Effects for

Treatment B (CHF 718 pMDI 400 µg TDD)
3%Asthma
2%Upper respiratory tract infection
2%Cough
1%Diplopia
1%Alcohol poisoning
1%Diverticulitis
1%Chest pain
1%Viral upper respiratory tract infection
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03084718) in the Treatment B (CHF 718 pMDI 400 µg TDD) ARM group. Side effects include: Asthma with 3%, Upper respiratory tract infection with 2%, Cough with 2%, Diplopia with 1%, Alcohol poisoning with 1%.

Trial Design

2 Treatment Groups

BDP/FF - CHF 1535
1 of 2
BDP/FF/GB - CHF 5993
1 of 2

Active Control

Experimental Treatment

2934 Total Participants · 2 Treatment Groups

Primary Treatment: Beclomethasone Dipropionate · No Placebo Group · Phase 3

BDP/FF/GB - CHF 5993Experimental Group · 3 Interventions: Formoterol Fumarate, Beclomethasone Dipropionate, Glycopyrronium Bromide · Intervention Types: Drug, Drug, Drug
BDP/FF - CHF 1535ActiveComparator Group · 2 Interventions: Formoterol Fumarate, Beclomethasone Dipropionate · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Formoterol
FDA approved
Beclomethasone dipropionate
FDA approved
Glycopyrronium
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1-week 4, week 4-week 10, week 10-week 28, week 28-week 40, week 40-week 52

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
180 Previous Clinical Trials
303,805 Total Patients Enrolled
53 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
48,034 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)
Gregory M Feldman, MDPrincipal InvestigatorVitalink Research - Spartanburg

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have COPD for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report.
You must have signed and dated a written informed consent prior to initiating any study-related procedures.
You are a current or ex-smoker who has quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years.
You have a pre- and post-bronchodilator FEV1/FVC ratio <0.
Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months prior to the screening and randomization visits.

Who else is applying?

What state do they live in?
Florida50.0%
Alabama25.0%
Missouri25.0%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
Chiesi Clinical Trial Site 840206100.0%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%
References