PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
1 other identifier
interventional
103
1 country
8
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 May 2011
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
8 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
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
June 8, 2017
CompletedJune 20, 2018
May 1, 2018
5 months
May 5, 2011
May 8, 2017
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1 AUC0-12
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Secondary Outcomes (8)
Peak Change From Baseline in FEV1 on Day 1
Day 1
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
Day 1 (15 min, 30 min, 1 hour, 2 hours)
Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1
Day 1
Peak Change From Baseline in IC on Day 1
Day 1
Change From Baseline in Morning Pre-dose FEV1 on Day 7
Day 7
- +3 more secondary outcomes
Study Arms (6)
PT001 MDI (Dose 1)
EXPERIMENTALPT001 MDI
PT001 MDI (Dose 2)
EXPERIMENTALPT001 MDI
PT001 MDI (Dose 3)
EXPERIMENTALPT001 MDI
PT001 MDI (Dose 4)
EXPERIMENTALPT001 MDI
Ipratropium Bromide HFA Inhalation Aerosol
ACTIVE COMPARATORIpratropium Bromide HFA Inhalation Aerosol
Placebo MDI
PLACEBO COMPARATORPT001 Placebo MDI
Interventions
PT001 MDI administered as two puffs BID for 7 days
Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
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 (8)
Pearl Investigative Site
Panama City, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Cherry Hill, New Jersey, United States
Pearl Investigative Site
Summit, New Jersey, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Longview, Texas, United States
Pearl Investigative Site
Richmond, Virginia, United States
Related Publications (1)
Kerwin EM, Spangenthal S, Kollar C, St Rose E, Reisner C. A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD. Respir Res. 2018 Mar 5;19(1):38. doi: 10.1186/s12931-018-0739-6.
PMID: 29506504DERIVED
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, M.D.
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
May 5, 2011
First Posted
May 9, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
June 20, 2018
Results First Posted
June 8, 2017
Record last verified: 2018-05