Phase 2 N=237 Randomized Quadruple-blind Treatment

PT003 MDI Cardiovascular Safety Study

Chronic Obstructive Pulmonary Disease

Bottom Line

View on ClinicalTrials.gov: NCT01349803 ↗

Enrolled (actual)

237

Serious AEs

1.3%

Results posted

Jan 2017

Primary outcome: Primary: Change From Baseline in 24-Hour Mean Heart Rate Post-dose — -0.19; -1.84; 0.40; -0.09 bpm

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PT005 MDI (Drug); PT001 MDI (Drug); PT003 MDI (Drug); Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Pearl Therapeutics, Inc.
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in 24-Hour Mean Heart Rate Post-dose	-0.19; -1.84; 0.40; -0.09	—
SECONDARY Change From Baseline in Mean FEV1 Trough	0.091; 0.126; 0.251; 0.124	—
SECONDARY Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment	0.56; -0.44; 0.92; 0.31	—
SECONDARY Change From Baseline in Daytime Mean Heart Rate	0.00; -0.52; 0.16; -0.17; -1.22; -2.00	—
SECONDARY Change From Baseline in Night Time Mean Heart Rate	3.05; -0.54; 2.95; 0.70; 0.04; -0.88	—
SECONDARY Change From Baseline in 24-Hour Maximum Heart Rate	-4.71; -1.88; -1.91; 0.31; 0.75; -2.21	—
SECONDARY Change From Baseline in 24-Hour Minimum Heart Rate	0.05; -0.03; 0.50; 0.45; -0.79; -1.92	—
SECONDARY Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring	1.31; 0.56; 1.59; 0.45; 3.09; 0.62	—
SECONDARY Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring	0.09; 0.00; 0.00; 0.00; 0.02; 0.00	—
SECONDARY Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring	-0.003; -0.001; 0.001; -0.003; -0.004; 0.001	—
SECONDARY Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring	7.72; 0.74; -4.55; 15.36; 3.61; -9.29	—
SECONDARY Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring	0.03; 0.01; 0.05; 0.04; 0.01; 0.00	—
SECONDARY Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring	0.00; 0.02; 0.01; 0.01; 0.01; 0.02	—
SECONDARY Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring	-0.04; -0.02; 0.11; 0.03; -0.02; 0.40	—
SECONDARY Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring	-0.16; -0.24; -0.02; -0.09; -0.23; -0.34	—
SECONDARY Mean Change From Baseline in QTcF Interval	1.53; 4.67; 3.27; 3.71; 1.75; 3.57	—

Summary

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Eligibility Criteria

Key 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 = 750ml or 30% predicted and < or = 80% of predicted normal values
Able to change COPD treatment as required by protocol
Acceptable baseline (Visit 2) Holter monitor recording

Key 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
Clinically significant abnormal findings during the baseline Holter recording
Patients with a pacemaker or ICD/CRT/CRT\_D devices

Other inclusion/exclusion criteria as defined by the protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01349803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.