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NCT04600505 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
A Phase 1 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT04600505: Completed Phase 1 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca.
NCT04600505 is a Phase 1 study of Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by AstraZeneca. The registered enrollment target is 47 participants, below the 650-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04600505, a Phase 1 study of Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A \[test\]), Propellant 2 (Treatment B \[test\]) and Hydrofluoroalkane (HFA) (Treatment C \[reference\]).
Primary Outcome
Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different propellants by Cmax.
Conditions Studied
Interventions
- DRUG Treatment A
- DRUG Treatment B
- DRUG Treatment C
Study Locations (1)
California
- Research Site - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2021-05-17 |
| Phase | Phase 1 |
What the finished NCT04600505 record still lists
NCT04600505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 650-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 3 interventions - of which Treatment A is the first listed.
NCT04600505 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04600505 about?
NCT04600505 is a clinical study titled "A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol". The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A \[test\]), Propellant 2 (Treatment B \[test\]) and Hydrofluoroalkane (H...
What is the current status of trial NCT04600505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-10-19. Estimated completion is 2021-05-17.
What conditions does trial NCT04600505 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).
What interventions are being tested in trial NCT04600505?
The interventions under investigation include: Treatment A (DRUG), Treatment B (DRUG), Treatment C (DRUG).
Who is sponsoring clinical trial NCT04600505?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04600505 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease (COPD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04600505's enrollment target sits among peer trials
47 32nd of 36 higher than 5 of 36 other Chronic Obstructive Pulmonary Disease (COPD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease (COPD) 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.
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