PT005 MDI Dose Ranging Versus Foradil Aerolizer Study
A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients With Moderate to Severe COPD, Compared With Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls
1 other identifier
interventional
50
1 country
3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease
Started May 2011
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 12, 2012
September 1, 2012
2 months
May 5, 2011
September 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo
The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.
1 Day
Secondary Outcomes (2)
Characterize the dose-response curve of PT005 MDI
1 Day
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events
1 Day
Study Arms (6)
PT005 MDI (Dose 1)
EXPERIMENTALPT005 MDI (Dose 1)
PT005 MDI (Dose 2)
EXPERIMENTALPT005 MDI (Dose 2)
PT005 MDI (Dose 3)
EXPERIMENTALPT005 MDI (Dose 3)
Placebo MDI
PLACEBO COMPARATORPlacebo MDI
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
ACTIVE COMPARATORFormoterol fumarate inhalation powder 12 μg
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
ACTIVE COMPARATORFormoterol fumarate inhalation powder 24 μg
Interventions
PT005 MDI taken as two inhalations
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
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
- Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (\> 12% and \>150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or \> 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA)
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 (3)
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 12, 2012
Record last verified: 2012-09