PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control
1 other identifier
interventional
140
1 country
10
Brief Summary
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease
Started Mar 2012
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
October 12, 2017
CompletedOctober 12, 2017
October 1, 2017
5 months
March 27, 2012
May 12, 2017
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1 AUC0-12
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)
Secondary Outcomes (24)
Peak Change From Baseline in FEV1
Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)
Percentage of Subjects Achieving at Least 12% Improvement in FEV1
Day 1
Peak Change From Baseline in Inspiratory Capacity (IC)
Day 1 (1 hr and 2 hr post-dose )
Change From Baseline in Morning Pre-dose Trough FEV1
Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
- +19 more secondary outcomes
Study Arms (8)
PT001 MDI (Dose 1)
EXPERIMENTALPT001 MDI (Dose 2)
EXPERIMENTALPT001 MDI (Dose 3)
EXPERIMENTALPT001 MDI (Dose 4)
EXPERIMENTALPT001 MDI (Dose 5)
EXPERIMENTALPT001 MDI (Dose 6)
EXPERIMENTALPT001 Placebo MDI
PLACEBO COMPARATORSpiriva® Handihaler® (Tiotropium Bromide)
ACTIVE COMPARATORInterventions
Administered as two puffs BID for 14 days
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
Eligibility Criteria
You may qualify if:
- Signed written informed consent
- years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
- A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
- Able to change COPD treatment as required by protocol
You may not qualify if:
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
- Abnormal chest X-ray (or CT scan) not due to the presence of COPD
- Hospitalized due to poorly controlled COPD within 3 months of Screening
- Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
- Cancer that has not been in complete remission for at least 5 years
- Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Pearl Investigative Site
Fullerton, California, 92835, United States
Pearl Investigative Site
Clearwater, Florida, 33765, United States
Pearl Investigative Site
Panama City, Florida, 32405, United States
Pearl Investigative Site
Tampa, Florida, 33603, United States
Pearl Investigative Site
Winter Park, Florida, 32789, United States
Pearl Investigative Site
Charlotte, North Carolina, 28207, United States
Pearl Investigative Site
Medford, Oregon, 97504, United States
Pearl Investigative Site
Spartanburg, South Carolina, 29303, United States
Pearl Investigative Site
Longview, Texas, 75605, United States
Pearl Investigative Site
Richmond, Virginia, 23225, United States
Related Publications (1)
Fabbri LM, Kerwin EM, Spangenthal S, Ferguson GT, Rodriguez-Roisin R, Pearle J, Sethi S, Orevillo C, Darken P, St Rose E, Fischer T, Golden M, Dwivedi S, Reisner C. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD. Respir Res. 2016 Sep 2;17(1):109. doi: 10.1186/s12931-016-0426-4.
PMID: 27586537DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Colin Reisner, MD, FCCP, FAAAAI
- Organization
- Pearl Therapeutics Inc
Study Officials
- STUDY DIRECTOR
Colin Reisner, MD
Pearl Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
March 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 12, 2017
Results First Posted
October 12, 2017
Record last verified: 2017-10