Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Tracking Information
First Submitted Date ICMJE	March 9, 2010
First Posted Date ICMJE	March 11, 2010
Results First Submitted Date	May 24, 2016
Results First Posted Date	April 26, 2017
Last Update Posted Date	April 26, 2017
Study Start Date ICMJE	March 2010
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 14, 2017)	FEV1 AUC 0-12 on Day 7 [ Time Frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7 ]; Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
Original Primary Outcome Measures ICMJE; (submitted: March 9, 2010)	Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline [ Time Frame: Day 7 ]; Day 7 time points for FEV1 are measured over 12 hrs
Change History	Complete list of historical versions of study NCT01085045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 14, 2017)	Peak Change From BL in FEV1 on Day 1 [ Time Frame: Day 1 ]Peak change from Baseline in FEV1 on Day 1; Peak Change From BL in FEV1 on Day 7 [ Time Frame: Day 7 ]Peak change from Baseline (BL) in FEV1 on Day 7; Peak Change From BL in Inspiratory Capacity on Day 1 [ Time Frame: Day 1 ]Peak change from Baseline in Inspiratory Capacity (IC) on Day 1; Peak Change From BL IC on Day 7 [ Time Frame: Day 7 ]Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration; Time to Onset of Action >=10% Improvement in FEV1 on Day 1 [ Time Frame: Day 1 ]Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%; Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1 [ Time Frame: Day 1 ]Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%; Change in Morning Pre-dose FEV1 on Day 7 [ Time Frame: Day 7 ]Change from Baseline in morning pre-dose FEV1 on Day 7; 12 hr Post-dose Trough FEV1 on Day 7 [ Time Frame: Day 7 ]12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7; Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7; Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7; Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7; Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7
Original Secondary Outcome Measures ICMJE; (submitted: March 9, 2010)	Lung function measures [ Time Frame: Day 7 ]Day 7 lung function is measured over 12 hrs; Safety measures including electrocardiograms (ECGs), vital signs, adverse events, tremors and dry mouth assessments, and clinical laboratory tests [ Time Frame: Throughout the study period ]Throughout the study period
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title ICMJE	A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls
Brief Summary	The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ICMJE	Drug: PT003 MDI Inhaled PT003 MDI administered as two puffs BID for 7 days; Drug: PT005 MDI Inhaled PT005 MDI administered as two puffs BID for 7 days; Drug: Placebo MDI Inhaled placebo administered as two puffs BID for 7 days; Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®) Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days; Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days; Drug: PT001 MDI Inhaled PT001 MDI administered as two puffs BID for 7 days
Study Arms	Experimental: Inhaled PT003 (Dose 1) PT003 MDI Dose 1 Intervention: Drug: PT003 MDI; Experimental: Inhaled PT003 (Dose 2) PT003 MDI Dose 2 Intervention: Drug: PT003 MDI; Experimental: Inhaled PT005 (Dose 1) PT005 MDI Dose 1 Intervention: Drug: PT005 MDI; Experimental: Inhaled PT005 (Dose 2) PT005 MDI Dose 2 Intervention: Drug: PT005 MDI; Placebo Comparator: Inhaled Placebo Placebo MDI Intervention: Drug: Placebo MDI; Active Comparator: Tiotropium bromide 18 μg (Spiriva Handihaler®) Tiotropium Bromide inhalation powder Intervention: Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®); Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol fumarate inhalation powder 12 μg Intervention: Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®); Experimental: Inhaled PT001 (Dose 1) PT001 MDI Dose 1 Intervention: Drug: PT001 MDI
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 20, 2010)	118
Original Estimated Enrollment ICMJE; (submitted: March 9, 2010)	84
Actual Study Completion Date	November 2010
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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 protocol defined inclusion/exclusion criteria may apply
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, New Zealand, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01085045
Other Study ID Numbers ICMJE	PT0031002
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Pearl Therapeutics, Inc.
Study Sponsor ICMJE	Pearl Therapeutics, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
PRS Account	Pearl Therapeutics, Inc.
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP