A9111004 - PF-03715455 in subjects with moderate to severe COPD

• Research type

  Research Study

• Full title

  A Randomized, Double Blind, Placebo-Controlled 2-Way Crossover Study to Evaluate the Efficacy, Safety and Tolerability of PF-03715455 Administered Twice Daily by Inhalation for 4 Weeks in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• IRAS ID

  161881

• Contact name

  Gemma Sheppard

• Contact email

  gemma.sheppard@inventivhealth.com

• Sponsor organisation

  Pfizer Limited

• Eudract number

  2014-002340-40

• Research summary

  COPD is a lung disease, usually related to smoking, in which the airways become inflamed and the small air sacs of the lungs become damaged. This results in a limitation of air flowing out of the lungs, reducing lung function and causing shortness of breath.

  The purpose of this research study is to learn about the effects and safety of the study drug, PF-03715455, in comparison with placebo in participants with moderate to severe COPD.

  A sputum substudy will also be carried out, whereby selected participants will provide a sputum (phlegm) sample at certain visits in addition to the other procedures and assessments required in this study. The purpose of the sputum substudy is to find out the effect of the study drug, PF-03715455, on the number of cells and certain protein levels within the sputum of COPD participants, in comparison with placebo.

  There will be approximately 80 people enrolled in this study, of which about 35 people will also take part in the sputum sub-study. The study is being done at about 8 different research sites in the United Kingdom. Only selected research sites will carry out the sputum substudy.

  This study will use competitive enrolment. This means that when a certain number of participants have entered the treatment phase of the study from all of the research sites combined, no more participants will be enrolled at any site.

  The participant will receive the following 2 treatments:
  • PF-03715455 – 680 micrograms inhaled using the Miat® inhaler device twice a day for 28 days
  • Placebo – placebo inhaled using the Miat® inhaler device twice a day for 28 days

  The order the participant receives PF-03715455 and placebo is assigned by chance.

  Participants will be in this study for about 18-22 weeks. They will need to visit the research site at least 12 times during the study.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  14/NW/1257

• Date of REC Opinion

  15 Sep 2014

• REC opinion

  Favourable Opinion