Back to resultsStudy 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)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PT003 MDI
PT005 MDI
Placebo MDI
Tiotropium bromide 18 μg (Spiriva Handihaler®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
PT001 MDI
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
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
Sites / Locations
- Clinical Research of West Florida, Inc.
- American Health Research
- Clinical Research Institute of Southern Oregon, PC
- Spartanburg Medical Research
- Austrials
- Woolcock
- Austrials
- Austrials
- Q-Pharm
- Respiratory Research Foundation - Burnside War Memorial Hospital
- Monash Medical Centre
- Lung Institute of WA
- Greenlane Clinical Centre
- NZ Respiratory & Sleep Institute
- Waikato Hospital
- P3 Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
Inhaled PT003 (Dose 1)
Inhaled PT003 (Dose 2)
Inhaled PT005 (Dose 1)
Inhaled PT005 (Dose 2)
Inhaled Placebo
Tiotropium bromide 18 μg (Spiriva Handihaler®)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Inhaled PT001 (Dose 1)
Arm Description
PT003 MDI Dose 1
PT003 MDI Dose 2
PT005 MDI Dose 1
PT005 MDI Dose 2
Placebo MDI
Tiotropium Bromide inhalation powder
Formoterol fumarate inhalation powder 12 μg
PT001 MDI Dose 1
Outcomes
Primary Outcome Measures
FEV1 AUC 0-12 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
Secondary Outcome Measures
Peak Change From BL in FEV1 on Day 1
Peak change from Baseline in FEV1 on Day 1
Peak Change From BL in FEV1 on Day 7
Peak change from Baseline (BL) in FEV1 on Day 7
Peak Change From BL in Inspiratory Capacity on Day 1
Peak change from Baseline in Inspiratory Capacity (IC) on Day 1
Peak Change From BL IC on 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 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 to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%
Change in Morning Pre-dose FEV1 on Day 7
Change from Baseline in morning pre-dose FEV1 on Day 7
12 hr Post-dose Trough FEV1 on 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
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
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
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
Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01085045
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pearl Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaled PT003 (Dose 1)
Arm Type
Experimental
Arm Description
PT003 MDI Dose 1
Arm Title
Inhaled PT003 (Dose 2)
Arm Type
Experimental
Arm Description
PT003 MDI Dose 2
Arm Title
Inhaled PT005 (Dose 1)
Arm Type
Experimental
Arm Description
PT005 MDI Dose 1
Arm Title
Inhaled PT005 (Dose 2)
Arm Type
Experimental
Arm Description
PT005 MDI Dose 2
Arm Title
Inhaled Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo MDI
Arm Title
Tiotropium bromide 18 μg (Spiriva Handihaler®)
Arm Type
Active Comparator
Arm Description
Tiotropium Bromide inhalation powder
Arm Title
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Arm Type
Active Comparator
Arm Description
Formoterol fumarate inhalation powder 12 μg
Arm Title
Inhaled PT001 (Dose 1)
Arm Type
Experimental
Arm Description
PT001 MDI Dose 1
Intervention Type
Drug
Intervention Name(s)
PT003 MDI
Intervention Description
Inhaled PT003 MDI administered as two puffs BID for 7 days
Intervention Type
Drug
Intervention Name(s)
PT005 MDI
Intervention Description
Inhaled PT005 MDI administered as two puffs BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo MDI
Intervention Description
Inhaled placebo administered as two puffs BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Tiotropium bromide 18 μg (Spiriva Handihaler®)
Intervention Description
Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Intervention Description
Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
Intervention Type
Drug
Intervention Name(s)
PT001 MDI
Intervention Description
Inhaled PT001 MDI administered as two puffs BID for 7 days
Primary Outcome Measure Information:
Title
FEV1 AUC 0-12 on Day 7
Description
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
Time Frame
"Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7
Secondary Outcome Measure Information:
Title
Peak Change From BL in FEV1 on Day 1
Description
Peak change from Baseline in FEV1 on Day 1
Time Frame
Day 1
Title
Peak Change From BL in FEV1 on Day 7
Description
Peak change from Baseline (BL) in FEV1 on Day 7
Time Frame
Day 7
Title
Peak Change From BL in Inspiratory Capacity on Day 1
Description
Peak change from Baseline in Inspiratory Capacity (IC) on Day 1
Time Frame
Day 1
Title
Peak Change From BL IC on Day 7
Description
Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration
Time Frame
Day 7
Title
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
Description
Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%
Time Frame
Day 1
Title
Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
Description
Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%
Time Frame
Day 1
Title
Change in Morning Pre-dose FEV1 on Day 7
Description
Change from Baseline in morning pre-dose FEV1 on Day 7
Time Frame
Day 7
Title
12 hr Post-dose Trough FEV1 on Day 7
Description
12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7
Time Frame
Day 7
Title
Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
Description
Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7
Time Frame
Day 7
Title
Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
Description
Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7
Time Frame
Day 7
Title
Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
Description
Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7
Time Frame
Day 7
Title
Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
Description
Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Reisner, M.D.
Organizational Affiliation
Pearl Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Austrials
City
Caringbah
State/Province
New South Wales
ZIP/Postal Code
2229
Country
Australia
Facility Name
Woolcock
City
Glebe
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Facility Name
Austrials
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Austrials
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Q-Pharm
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Respiratory Research Foundation - Burnside War Memorial Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Lung Institute of WA
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6006
Country
Australia
Facility Name
Greenlane Clinical Centre
City
Epsom
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
NZ Respiratory & Sleep Institute
City
Greenlane East
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
P3 Research
City
Crofton Downs
State/Province
Wellington
ZIP/Postal Code
6143
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
28061907
Citation
Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8. Erratum In: Respir Res. 2017 Aug 21;18(1):158.
Results Reference
derived
Learn more about this trial
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)
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