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Corticosteroid/Bronchodilator/Anticholinergic

Single supra-therapeutic dose of CHF5993 (BDP/FF/GB) for Chronic Obstructive Pulmonary Disease

Phase 1
Waitlist Available
Led By Ronald Goldwater, MDCM/M.SC(A)
Research Sponsored by Chiesi Farmaceutici S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start through study completion, an average of 4 months
Awards & highlights

Study Summary

This trial tests a new drug's effect on cardiac repolarization in healthy people, compared to existing drugs and placebo.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease
  • Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start through study completion, an average of 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start through study completion, an average of 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of BDP/FF/GB pMDI at therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Secondary outcome measures
Abnormal clinical chemistry and haematology laboratory tests
Abnormal results of physical examinations
Analysis of Area under the curve from 0 to 12 hours post-dose (AUC0-12), pharmacokinetic parameter of FF, GB, BDP and B17MP
+18 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Single therapeutic dose of CHF5993 (BDP/FF/GB)Experimental Treatment2 Interventions
Dose: BDP/FF/GB 100/6/12.5 μg, single dose inhalation via pressurized metered dose inhaler (2 puffs from 1 BDP/FF/GB 100/6/12.5 μg pMDI + 2 puffs from 3 placebo pMDI)
Group II: Single supra-therapeutic dose of CHF5993 (BDP/FF/GB)Experimental Treatment1 Intervention
Dose: BDP/FF/GB 800/48/100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 BDP/FF/GB 100/6/12.5 μg pMDI)
Group III: Single supra-therapeutic dose CHF5259 (GB)Experimental Treatment1 Intervention
Dose: GB 100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 GB 12.5 μg pMDI)
Group IV: MoxifloxacinActive Control1 Intervention
Dose: moxifloxacin 400 mg single dose, for oral use - open label treatment (1 tablet of moxifloxacin 400 mg PO)
Group V: Single dose PlaceboPlacebo Group1 Intervention
Dose: placebo single dose inhalation, via pressurized metered dose inhaler 8 puffs from 4 CHF5993 placebo pMDI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CHF5259
2023
Completed Phase 1
~100
CHF5993
2021
Completed Phase 4
~210
CHF5993 Placebo
2023
Completed Phase 1
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
198 Previous Clinical Trials
311,819 Total Patients Enrolled
Ronald Goldwater, MDCM/M.SC(A)Principal InvestigatorPAREXEL Baltimore Early Phase Clinical Unit

Media Library

CHF5993 (Corticosteroid/Bronchodilator/Anticholinergic) Clinical Trial Eligibility Overview. Trial Name: NCT05830071 — Phase 1
Chronic Obstructive Pulmonary Disease Research Study Groups: Single dose Placebo, Moxifloxacin, Single supra-therapeutic dose of CHF5993 (BDP/FF/GB), Single supra-therapeutic dose CHF5259 (GB), Single therapeutic dose of CHF5993 (BDP/FF/GB)
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: CHF5993 Highlights & Side Effects. Trial Name: NCT05830071 — Phase 1
CHF5993 (Corticosteroid/Bronchodilator/Anticholinergic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05830071 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor seeking individuals aged 45 or older for participation?

"In accordance with the requirements for this clinical trial, participants must be between 18 and 55 years old."

Answered by AI

Are there any health hazards associated with a one-time dosage of CHF5993 (BDP/FF/GB)?

"With limited data on safety and efficacy, we give Single therapeutic dose of CHF5993 (BDP/FF/GB) a score of 1."

Answered by AI

What is the eligibility criterion for participation in this clinical investigation?

"To be eligible for this study, individuals should possess a diagnosis of asthma and must range in age from 18 to 55 years old. Currently, the researchers are looking to recruit around 95 participants."

Answered by AI

Do you have any openings for volunteers to participate in this research?

"Affirmative. According to the clinicaltrials.gov website, this research project is currently recruiting participants and has been since March 29th 2023. The most recent modifications were made on April 13th 2023 and 95 individuals are being sought from a single medical site for inclusion in the study."

Answered by AI

How many people are enrolled in this research endeavor?

"Affirmative. Clinicaltrials.gov documents demonstrate that this trial, first posted on March 29th 2023 is actively recruiting individuals for participation. A total of 95 patients from a single medical site are requisite to complete the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
2023. "A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05830071.
~47 spots leftby Apr 2025
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