Last updated on November 2017

This is a randomized, double-blind, parallel-group, 52-week, chronic-dosing, multi-center supplemental study to assess the effects of PT010, PT009, and PT003 on bone mineral density (BMD) measurements, ocular assessments, and safety and tolerability in subjects with moderate to very severe COPD. This 52-week supplemental study will be conducted in a sub-set of subjects participating in Study PT010006.


Brief description of study

This is a randomized, double-blind, parallel-group, 52-week, chronic-dosing, multi-center supplemental study to assess the effects of PT010, PT009, and PT003 on bone mineral density (BMD) measurements, ocular assessments, and safety and tolerability in subjects with moderate to very severe COPD. This 52-week supplemental study will be conducted in a sub-set of subjects participating in Study PT010006.

Detailed Study Description

This is a research study to test investigational drugs for which Pearl Therapeutics plans to seek marketing approval from the U.S. Food and Drug Administration (FDA) and Regulatory Authorities in other countries. The purpose of this study is to:

  • Evaluate the effect of BGF MDI, GFF MDI, and BFF MDI on bone health over 52 weeks
  • Evaluate the effect of BGF MDI, GFF MDI, and BFF MDI on eye function over 52 weeks
  • Assess the safety and tolerability of BGF MDI, GFF MDI, and BFF MDI over 52 weeks

Clinical Study Identifier: TX5909

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Southeast Regional Research Group - ...

Southeast Regional Research Group - Savannah
Rincon, GA USA
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