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NCT01980615 · ClinicalTrials.gov registry record · Phase 1
Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers
A Phase 1 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT01980615: Completed Phase 1 study, sponsored by Pearl Therapeutics.
NCT01980615 is a Phase 1 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980615, a Phase 1 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure \[pharmacokinetics (PK)\] to budesonide following administration of Symbicort MDI.
Primary Outcome
Safety of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort Inhalation Aerosol. The safety of BGF MDI, Symbicort MDI and GFF MDI will be assessed from physical examination findings, adverse event (AE) reporting including SAE reporting, vital signs (blood pressure, heart rate, respiratory rate and body temperature), clinical laboratory values
Interventions
- DRUG Inhaled BGF (PT010) Dose 1
- DRUG Inhaled BGF (PT010) Dose 2
- DRUG Inhaled BGF (PT010) Dose 3
- DRUG Inhaled GFF (PT003)
- DRUG Inhaled Symbicort Dose 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2013-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01980615 record still lists
NCT01980615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 5 interventions - of which Inhaled BGF (PT010) Dose 1 is the first listed.
NCT01980615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01980615 about?
NCT01980615 is a clinical study titled "Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers". This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formotero...
What is the current status of trial NCT01980615?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2013-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01980615?
The interventions under investigation include: Inhaled BGF (PT010) Dose 1 (DRUG), Inhaled BGF (PT010) Dose 2 (DRUG), Inhaled BGF (PT010) Dose 3 (DRUG), Inhaled GFF (PT003) (DRUG), Inhaled Symbicort Dose 1 (DRUG).
Who is sponsoring clinical trial NCT01980615?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01980615's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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