Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04320342 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD
A Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 3,433
- Enrollment target
NCT04320342: Completed Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT04320342 is a Phase 3 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 3,433 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (345% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04320342, a Phase 3 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,433 participants
- Enrollment target
Study Summary
The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.
Interventions
- DRUG Formoterol Fumarate
- DRUG Beclomethasone Dipropionate
- DRUG Glycopyrronium Bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,433 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2026-01-12 |
| Phase | Phase 3 |
What the finished NCT04320342 record still lists
NCT04320342 is an interventional study that assigns participants to a tested intervention. Its 3,433 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (345% higher).
The record links to 0 conditions, and to 3 interventions - of which Formoterol Fumarate is the first listed.
NCT04320342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04320342 about?
NCT04320342 is a clinical study titled "A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD". The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.
What is the current status of trial NCT04320342?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,433 participants. The study started on 2022-04-28. Estimated completion is 2026-01-12.
What interventions are being tested in trial NCT04320342?
The interventions under investigation include: Formoterol Fumarate (DRUG), Beclomethasone Dipropionate (DRUG), Glycopyrronium Bromide (DRUG).
Who is sponsoring clinical trial NCT04320342?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04320342's enrollment target sits among peer trials
3,433 70th of 2000 higher than 1,931 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03474029 · 3,400 participants · Phase 2
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
- NCT07142954 · 3,400 participants · Phase 3
Epidemiology and Biomarker Study in Alzheimer's Disease
- NCT06880055 · 3,375 participants
Shield Post-Approval Study Protocol
- NCT00260559 · 3,500 participants
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI