PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566773
• Other study ID #: PT001003
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2012
• Last updated: November 14, 2013
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: October 2017
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent

• 40 - 80 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

Exclusion Criteria:

• 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

Other inclusion/exclusion criteria as defined in the protocol

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PT001 MDI
Administered as two puffs BID for 14 days
• Tiotropium Bromide
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
• PT001 Placebo MDI

Locations

Country	Name	City	State
United States	Pearl Investigative Site	Charlotte	North Carolina
United States	Pearl Investigative Site	Clearwater	Florida
United States	Pearl Investigative Site	Fullerton	California
United States	Pearl Investigative Site	Longview	Texas
United States	Pearl Investigative Site	Medford	Oregon
United States	Pearl Investigative Site	Panama City	Florida
United States	Pearl Investigative Site	Richmond	Virginia
United States	Pearl Investigative Site	Spartanburg	South Carolina
United States	Pearl Investigative Site	Tampa	Florida
United States	Pearl Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peak Change From Baseline in FEV1	Highest value of FEV1 post dose on day 1	Day 1
Secondary	Time to Onset of Action (>10% Improvement in FEV1) on 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)
Secondary	Percentage of Subjects Achieving at Least 12% Improvement in FEV1	Percentage of subjects achieving at least 12% improvement in FEV1.	Day 1
Secondary	Peak Change From Baseline in Inspiratory Capacity (IC)	Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline	Day 1 (1 hr and 2 hr post-dose )
Secondary	Change From Baseline in Morning Pre-dose Trough FEV1	Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)	Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Secondary	Peak Change From Baseline in FEV1	Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)	Day 7
Secondary	Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)	Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)	Day 7
Secondary	Peak Change From Baseline in IC	Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)	Day 7 (mean of 1 hr and 2 hr post-dose assessments)
Secondary	Change From Baseline in Mean Morning Pre-dose Daily PEFR	Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])	Day 7 (60 minutes pre-dose, 30 minutes pre-dose)
Secondary	Change From Baseline in Morning Post-dose Daily PEFR	Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])	Day 7 (30 minutes post-dose)
Secondary	Change From Baseline in Mean Evening Pre-dose PEFR	Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)	Day 7
Secondary	Change From Baseline in Mean Evening Post-dose PEFR	Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)	Day 7
Secondary	Mean Number of Puffs of Rescue Medication	Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated	Day 7
Secondary	Change From Baseline in Morning Pre-dose Trough FEV1	Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)	Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Secondary	Peak Change From Baseline in FEV1	Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)	Day 14
Secondary	Change From Baseline for Mean Morning Pre-dose Trough IC	Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)	Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Secondary	Peak Change From Baseline in IC	Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)	Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)
Secondary	Change From Baseline in 12-hour Post-dose Trough FEV1	12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline	Day 14 (Baseline, 11.5 and 12 hours post dose)
Secondary	Change From Baseline in Mean Morning Pre-dose Daily PEFR	Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]	Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Secondary	Change From Baseline in Mean Morning Post-dose Daily PEFR	Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]	Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Secondary	Change From Baseline in Mean Evening Pre-dose Daily PEFR	Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)	Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Secondary	Change From Baseline in Mean Evening Post-dose Daily PEFR	Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)	Through the end of the 14-Day Treatment
Secondary	Mean Number of Puffs of Rescue Medication (End of Treatment)	Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated	Day 14 (End of treatment)
Secondary	Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14	Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14	Day 1 through Day 14

External Links

•   protocol-pt001003_FINAL_Redacted