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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085045
First Posted: March 11, 2010
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
Results First Submitted: May 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: PT003 MDI
Drug: PT005 MDI
Drug: Placebo MDI
Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Drug: PT001 MDI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Conducted at 16 sites in Australia, New Zealand and the US from 24 March 2010 -28 October 2010. The entire study period was a maximum of 20 weeks. Chronic dosing (7 days), 4-period, 8-treatment, incomplete block, cross-over conducted in two parts.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part A: 4-period, 8-treatment, incomplete block cross-over. Subjects randomized to 1 of 48 sequences, each subject received 4 of 8 possible treatments. Part B: 4-period, 4-treatment, full cross-over. Each subject randomized to 1 of 24 sequences and each sequence was assigned to at least 1 subject.

Reporting Groups
  Description
Overall Study Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6

Participant Flow for 2 periods

Period 1:   Part A
    Overall Study
STARTED   122 
GFF MDI 72/9.6mcg   40 
GFF MDI 36/9.6 µg (PT003)   42 
GP MDI 36 µg (PT001)   40 
Spiriva 18 µg   58 
FF MDI 9.6 µg (PT005)   20 
FF MDI 7.2 µg (PT005)   21 
Placebo MDI   5 
Foradil 12 µg   14 
COMPLETED   104 
NOT COMPLETED   18 
Withdrawal by Subject                4 
Adverse Event                6 
Protocol Violation                1 
Protocol Specified Criteria                7 

Period 2:   Part B
    Overall Study
STARTED   104 
GFF MDI 72/9.6mcg (PT003)   0 
GFF MDI 36/9.6 µg   0 
Spiriva 18 µg   0 
FF MDI 9.6 µg (PT005)   43 
FF MDI 7.2 µg (PT005)   43 
Placebo MDI   47 
Foradil 12 µg   41 
GP MDI 36 µg (PT001)   0 
COMPLETED   89 
NOT COMPLETED   15 
Withdrawal by Subject                2 
Protocol Specified Criteria                6 
Lost to Follow-up                1 
Adverse Event                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis Population included all randomized participants. 118 plus 4 sentinel patients to make 122.

Reporting Groups
  Description
All Subjects All Baseline Subjects

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 122 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.4  (8.92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      53  43.4% 
Male      69  56.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Peak Change From BL in FEV1 on Day 1   [ Time Frame: Day 1 ]

3.  Secondary:   Peak Change From BL in FEV1 on Day 7   [ Time Frame: Day 7 ]

4.  Secondary:   Peak Change From BL in Inspiratory Capacity on Day 1   [ Time Frame: Day 1 ]

5.  Secondary:   Peak Change From BL IC on Day 7   [ Time Frame: Day 7 ]

6.  Secondary:   Time to Onset of Action >=10% Improvement in FEV1 on Day 1   [ Time Frame: Day 1 ]

7.  Secondary:   Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1   [ Time Frame: Day 1 ]

8.  Secondary:   Change in Morning Pre-dose FEV1 on Day 7   [ Time Frame: Day 7 ]

9.  Secondary:   12 hr Post-dose Trough FEV1 on Day 7   [ Time Frame: Day 7 ]

10.  Secondary:   Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7   [ Time Frame: Day 7 ]

11.  Secondary:   Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7   [ Time Frame: Day 7 ]

12.  Secondary:   Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7   [ Time Frame: Day 7 ]

13.  Secondary:   Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7   [ Time Frame: Day 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Colin Reisner, MD, FCCP, FAAAAI
Organization: Pearl Therapeutics, Inc
phone: 650-305-2600
e-mail: creisner@pearltherapeutics.com



Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01085045     History of Changes
Other Study ID Numbers: PT0031002
First Submitted: March 9, 2010
First Posted: March 11, 2010
Results First Submitted: May 24, 2016
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017