Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT02196077. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double Blind, Chronic Dosing (28 Days), Four Period, Five Treatment, Incomplete Block, Multi Center, Crossover Study to Assess the Efficacy and Safety of PT009, PT008, and PT005 in Subjects With Moderate to Severe COPD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.
Study identification
- NCT ID
- NCT02196077
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Interventions
- BFF MDI 320/9.6 μg Drug
- BFF MDI 160/9.6 μg Drug
- BFF MDI 80/9.6 μg Drug
- BD MDI 320 μg Drug
- FF MDI 9.6 μg Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2014
- Primary completion
- Feb 28, 2015
- Completion
- Feb 28, 2015
- Last update posted
- Jun 19, 2018
2014 – 2015
United States locations
- U.S. sites
- 17
- U.S. states
- 8
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pearl Investigative Site | Rolling Hills Estates | California | — | — |
| Pearl Investigative Site | Clearwater | Florida | — | — |
| Pearl Investigative Site | Panama City | Florida | — | — |
| Pearl Investigative Site | Tampa | Florida | — | — |
| Pearl Investigative Site | Winter Park | Florida | — | — |
| Pearl Investigative Site | Edina | Minnesota | — | — |
| Pearl Investigative Site | Minneapolis | Minnesota | — | — |
| Pearl Investigative Site | Woodbury | Minnesota | — | — |
| Pearl Investigative Site | Saint Charles | Missouri | — | — |
| Pearl Investigative Site | Charlotte | North Carolina | — | — |
| Pearl Investigative Site | Cincinnati | Ohio | — | — |
| Pearl Investigative Site | Columbus | Ohio | — | — |
| Pearl Investigative Site | Dublin | Ohio | — | — |
| Pearl Investigative Site | Medford | Oregon | — | — |
| Pearl Investigative Site | Easley | South Carolina | — | — |
| Pearl Investigative Site | Greenville | South Carolina | — | — |
| Pearl Investigative Site | Spartanburg | South Carolina | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02196077, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 19, 2018 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02196077 live on ClinicalTrials.gov.