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PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01350128
First received: May 5, 2011
Last updated: May 8, 2017
Last verified: April 2017
Results First Received: May 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: PT001 MDI
Drug: Ipratropium Bromide HFA Inhalation Aerosol
Other: Placebo 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 9 US sites from May-October 2011. Entire period of study participation per subject was a maximum of 15 weeks. Planned target enrollment of 84 subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a chronic dosing study (7 days), 3-period, 6-treatment, incomplete block, crossover study. Each subject received 3 of 6 possible treatments; each treatment period was separated by a washout period 7-28 days. By-treatment sequence tabulations of the data were not pre-specified.

Reporting Groups
  Description
All Subjects Randomized No text entered.

Participant Flow:   Overall Study
    All Subjects Randomized
STARTED   103 
GP MDI 36 µg BID   49 [1] 
GP MDI 18 µg BID   49 
GP MDI 9 µg BID   49 
GP MDI 4.6 µg BID   45 
Placebo MDI BID   48 
Atrovent HFA 34 µg BID   48 
COMPLETED   89 
NOT COMPLETED   14 
Withdrawal by Subject                3 
Protocol discontinuation criteria                8 
Physician Decision                1 
Lost to Follow-up                2 
[1] Glycopyrronium Metered Dose Inhaler



  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.
Intent-to-Treat (ITT) Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.

Reporting Groups
  Description
ITT Population ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.

Baseline Measures
   ITT Population 
Overall Participants Analyzed 
[Units: Participants]
 103 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.2  (8.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      48  46.6% 
Male      55  53.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   FEV1 AUC0-12   [ Time Frame: Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours) ]

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

3.  Secondary:   Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1   [ Time Frame: Day 1 (15 min, 30 min, 1 hour, 2 hours) ]

4.  Secondary:   Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1   [ Time Frame: Day 1 ]

5.  Secondary:   Peak Change From Baseline in IC on Day 1   [ Time Frame: Day 1 ]

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

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

8.  Secondary:   Peak Change From Baseline in IC on Day 7   [ Time Frame: Day 7 ]

9.  Secondary:   Change From Baseline in 12-hour Post-dose Trough FEV1 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
No text entered.


  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: NCT01350128     History of Changes
Other Study ID Numbers: PT001002
Study First Received: May 5, 2011
Results First Received: May 8, 2017
Last Updated: May 8, 2017