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Completed Phase 3 Interventional Results available

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

ClinicalTrials.gov ID: NCT01854645

Public ClinicalTrials.gov record NCT01854645. 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.

ClinicalTrials.gov public records Last synced May 5, 2026, 4:27 AM EDT

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, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

Study identification

NCT ID
NCT01854645
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Enrollment
2,103 participants

Conditions and interventions

Interventions

  • FF MDI Drug
  • GFF MDI Drug
  • GP MDI Drug
  • Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) Drug
  • Placebo MDI 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
Apr 30, 2013
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015
Last update posted
Mar 27, 2017

2013 – 2015

United States locations

U.S. sites
121
U.S. states
38
U.S. cities
121
Facility City State ZIP Site status
Pearl Investigative Site Andalusia Alabama
Pearl Investigative Site Anniston Alabama
Pearl Investigative Site Athens Alabama
Pearl Investigative Site Birmingham Alabama
Pearl Investigative Site Mesa Arizona
Pearl Investigative Site Phoenix Arizona
Pearl Investigative Site Scottsdale Arizona
Pearl Investigative Site Tucson Arizona
Pearl Investigative Site Anaheim California
Pearl Investigative Site Carlsbad California
Pearl Investigative Site Lakewood California
Pearl Investigative Site Los Angeles California
Pearl Investigative Site Pasadena California
Pearl Investigative Site Poway California
Pearl Investigative Site Sacramento California
Pearl Investigative Site San Diego California
Pearl Investigative Site Tustin California
Pearl Investigative Site Vista California
Pearl Investigative Site Colorado Springs Colorado
Pearl Investigative Site Denver Colorado
Pearl Investigative Site Fort Collins Colorado
Pearl Investigative Site Wheat Ridge Colorado
Pearl Investigative Site Danbury Connecticut
Pearl Investigative Site Waterbury Connecticut
Pearl Investigative Site Brandon Florida
Pearl Investigative Site Clearwater Florida
Pearl Investigative Site Lehigh Acres Florida
Pearl Investigative Site Miami Florida
Pearl Investigative Site Ormond Beach Florida
Pearl Investigative Site Panama City Florida
Pearl Investigative Site Pensacola Florida
Pearl Investigative Site St. Petersburg Florida
Pearl Investigative Site Tampa Florida
Pearl Investigative Site Winter Park Florida
Pearl Investigative Site Atlanta Georgia
Pearl Investigative Site Austell Georgia
Pearl Investigative Site Columbus Georgia
Pearl Investigative Site Duluth Georgia
Pearl Investigative Site Gainesville Georgia
Pearl Investigative Site Coeur d'Alene Idaho
Pearl Investigative Site Champaign Illinois
Pearl Investigative Site Evanston Illinois
Pearl Investigative Site Peoria Illinois
Pearl Investigative Site River Forest Illinois
Pearl Investigative Site Anderson Indiana
Pearl Investigative Site Avon Indiana
Pearl Investigative Site Elwood Indiana
Pearl Investigative Site Evansville Indiana
Pearl Investigative Site Iowa City Iowa
Pearl Investigative Site Topeka Kansas
Pearl Investigative Site Louisville Kentucky
Pearl Investigative Site Lafayette Louisiana
Pearl Investigative Site Sunset Louisiana
Pearl Investigative Site Baltimore Maryland
Pearl Investigative Site Hollywood Maryland
Pearl Investigative Site Livonia Michigan
Pearl Investigative Site Southfield Michigan
Pearl Investigative Site Edina Minnesota
Pearl Investigative Site Fridley Minnesota
Pearl Investigative Site Minneapolis Minnesota
Pearl Investigative Site Woodbury Minnesota
Pearl Investigative Site Saint Charles Missouri
Pearl Investigative Site Springfield Missouri
Pearl Investigative Site St Louis Missouri
Pearl Investigative Site Missoula Montana
Pearl Investigative Site Bellevue Nebraska
Pearl Investigative Site Omaha Nebraska
Pearl Investigative Site Las Vegas Nevada
Pearl Investigative Site Ocean City New Jersey
Pearl Investigative Site Albuquerque New Mexico
Pearl Investigative Site Corning New York
Pearl Investigative Site Burlington North Carolina
Pearl Investigative Site Charlotte North Carolina
Pearl Investigative Site Greensboro North Carolina
Pearl Investigative Site Huntersville North Carolina
Pearl Investigative Site Raleigh North Carolina
Pearl Investigative Site Wilmington North Carolina
Pearl Investigative Site Winston-Salem North Carolina
Pearl Investigative Site Cincinnati Ohio
Pearl Investigative Site Columbus Ohio
Pearl Investigative Site Dayton Ohio
Pearl Investigative Site Dublin Ohio
Pearl Investigative Site Oregon Ohio
Pearl Investigative Site Bend Oregon
Pearl Investigative Site Medford Oregon
Pearl Investigative Site Portland Oregon
Pearl Investigative Site Monroeville Pennsylvania
Pearl Investigative Site Philadelphia Pennsylvania
Pearl Investigative Site Charleston South Carolina
Pearl Investigative Site Easley South Carolina
Pearl Investigative Site Gaffney South Carolina
Pearl Investigative Site Greenville South Carolina
Pearl Investigative Site Mt. Pleasant South Carolina
Pearl Investigative Site Murrells Inlet South Carolina
Pearl Investigative Site Myrtle Beach South Carolina
Pearl Investigative Site Rock Hill South Carolina
Pearl Investigative Site Spartanburg South Carolina
Pearl Investigative Site Union South Carolina
Pearl Investigative Site Rapid City South Dakota
Pearl Investigative Site Bristol Tennessee
Pearl Investigative Site Johnson City Tennessee
Pearl Investigative Site Kingsport Tennessee
Pearl Investigative Site Tullahoma Tennessee
Pearl Investigative Site Austin Texas
Pearl Investigative Site El Paso Texas
Pearl Investigative Site Fort Worth Texas
Pearl Investigative Site Houston Texas
Pearl Investigative Site Huntsville Texas
Pearl Investigative Site Longview Texas
Pearl Investigative Site Lufkin Texas
Pearl Investigative Site New Braunfels Texas
Pearl Investigative Site San Antonio Texas
Pearl Investigative Site Midvale Utah
Pearl Investigative Site Salt Lake City Utah
Pearl Investigative Site South Burlington Vermont
Pearl Investigative Site Abingdon Virginia
Pearl Investigative Site Richmond Virginia
Pearl Investigative Site Spokane Washington
Pearl Investigative Site Tacoma Washington
Pearl Investigative Site Morgantown West Virginia
Pearl Investigative Site West Allis Wisconsin

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01854645, 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 Mar 27, 2017 · Synced May 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01854645 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →