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Completed

NCT Number: NCT01566773

PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pearl Investigative Site, Fullerton, California, United States

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About this study

The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 inclusion/exclusion criteria as defined in the protocol

Treatment and study plan

PT001 MDI

Drug

Administered as two puffs BID for 14 days

Tiotropium Bromide

Drug

Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI

Other names: Spiriva® Handihaler®

PT001 Placebo MDI

Drug

Primary outcomes

  1. FEV1 AUC0-12

    Time frame: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)

    Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.

Secondary outcomes

  1. Peak Change From Baseline in FEV1

    Time frame: Day 1

    Highest value of FEV1 post dose on day 1

  2. Time to Onset of Action (>10% Improvement in FEV1) on Day 1

    Time frame: Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)

    Time to Onset of Action (>10% Improvement in FEV1) on Day 1.

  3. Percentage of Subjects Achieving at Least 12% Improvement in FEV1

    Time frame: Day 1

    Percentage of subjects achieving at least 12% improvement in FEV1.

  4. Peak Change From Baseline in Inspiratory Capacity (IC)

    Time frame: Day 1 (1 hr and 2 hr post-dose )

    Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline

  5. Change From Baseline in Morning Pre-dose Trough FEV1

    Time frame: Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)

    Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)

  6. Peak Change From Baseline in FEV1

    Time frame: Day 7

    Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)

  7. Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)

    Time frame: Day 7

    Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)

  8. Peak Change From Baseline in IC

    Time frame: Day 7 (mean of 1 hr and 2 hr post-dose assessments)

    Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)

  9. Change From Baseline in Mean Morning Pre-dose Daily PEFR

    Time frame: Day 7 (60 minutes pre-dose, 30 minutes pre-dose)

    Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])

  10. Change From Baseline in Morning Post-dose Daily PEFR

    Time frame: Day 7 (30 minutes post-dose)

    Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])

  11. Change From Baseline in Mean Evening Pre-dose PEFR

    Time frame: Day 7

    Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)

  12. Change From Baseline in Mean Evening Post-dose PEFR

    Time frame: Day 7

    Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)

  13. Mean Number of Puffs of Rescue Medication

    Time frame: Day 7

    Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated

  14. Change From Baseline in Morning Pre-dose Trough FEV1

    Time frame: Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)

    Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)

  15. Peak Change From Baseline in FEV1

    Time frame: Day 14

    Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)

  16. Change From Baseline for Mean Morning Pre-dose Trough IC

    Time frame: Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)

    Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)

  17. Peak Change From Baseline in IC

    Time frame: Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)

    Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)

  18. Change From Baseline in 12-hour Post-dose Trough FEV1

    Time frame: Day 14 (Baseline, 11.5 and 12 hours post dose)

    12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline

  19. Change From Baseline in Mean Morning Pre-dose Daily PEFR

    Time frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)

    Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]

  20. Change From Baseline in Mean Morning Post-dose Daily PEFR

    Time frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)

    Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]

  21. Change From Baseline in Mean Evening Pre-dose Daily PEFR

    Time frame: Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)

    Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)

  22. Change From Baseline in Mean Evening Post-dose Daily PEFR

    Time frame: Through the end of the 14-Day Treatment

    Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)

  23. Mean Number of Puffs of Rescue Medication (End of Treatment)

    Time frame: Day 14 (End of treatment)

    Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated

  24. Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14

    Time frame: Day 1 through Day 14

    Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2012
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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