A Randomized, double-blind, parallel-group, 12-week, chronic-dosing, multi-center study to assess the efficacy and safety of PT010 compared to PT009 in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).

  • STATUS
    Recruiting
  • sponsor
    Pearl Therapeutics
Updated on 25 March 2021

Summary

A Randomized, double-blind, parallel-group, 12-week, chronic-dosing, multi-center study to assess the efficacy and safety of PT010 compared to PT009 in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).

Description

This study is comparing a fixed-dose Triple combination product to a fixed-dose dual combination product. The study is for a 12-week duration. We are also including an option for a 24-hour Holter Monitoring as a sub-study to the main study. Compensation is provided for your time and travel expenses.
For more information please contact our office at 636-946-1650.

Details
Clinical Study IdentifierTX147806
SponsorPearl Therapeutics
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be 40 years of age and not over 80 year of age to be eligible
Must have been a previous or a current smoker with at least a 10-pack year history which means an average of one pack per day for 10 years
You cannot have a diagnosis of Asthma
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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