PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
NCT ID: NCT01566773
Last Updated: 2017-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2012-03-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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PT001 MDI (Dose 1)
PT001 MDI
Administered as two puffs BID for 14 days
PT001 MDI (Dose 2)
PT001 MDI
Administered as two puffs BID for 14 days
PT001 MDI (Dose 3)
PT001 MDI
Administered as two puffs BID for 14 days
PT001 MDI (Dose 4)
PT001 MDI
Administered as two puffs BID for 14 days
PT001 MDI (Dose 5)
PT001 MDI
Administered as two puffs BID for 14 days
PT001 MDI (Dose 6)
PT001 MDI
Administered as two puffs BID for 14 days
PT001 Placebo MDI
PT001 Placebo MDI
Spiriva® Handihaler® (Tiotropium Bromide)
Tiotropium Bromide
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Colin Reisner, MD
Role: STUDY_DIRECTOR
Pearl Therapeutics, Inc.
Locations
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Pearl Investigative Site
Fullerton, California, United States
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Panama City, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Pearl Investigative Site
Longview, Texas, United States
Pearl Investigative Site
Richmond, Virginia, United States
Countries
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References
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Fabbri LM, Kerwin EM, Spangenthal S, Ferguson GT, Rodriguez-Roisin R, Pearle J, Sethi S, Orevillo C, Darken P, St Rose E, Fischer T, Golden M, Dwivedi S, Reisner C. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD. Respir Res. 2016 Sep 2;17(1):109. doi: 10.1186/s12931-016-0426-4.
Related Links
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protocol-pt001003\_FINAL\_Redacted
Other Identifiers
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PT001003
Identifier Type: -
Identifier Source: org_study_id