PD study comparing Salmeterol dose/response through bronchodilation

• Research type

  Research Study

• Full title

  A Pharmacodynamic Study of Salmeterol Xinafoate as a Dry Powder in Combination with Fluticasone in Patients with Asthma for Dose-Scale Bronchodilator Comparison of a Test and Reference Product

• IRAS ID

  83544

• Sponsor organisation

  Oriel Therapeutics Inc, a Sandoz Company

• Eudract number

  2011-002404-32

• ISRCTN Number

  xx

• Research summary

  This study is being carried out on behalf of Oriel Therapeutics (the Sponsor, a pharmaceutical company based in the US) by Quintiles. Oriel Therapeutics is currently developing a new dry powder inhalation device OT329 Solis containing the drugfluicasone propionate and salmeterol xinafoate (referred to afluicasone and salmeterol throughout this document) for the maintenance treatment of asthma. Preparations containinfluicasone and salmeterol as inhaled medication are well established prophylactic therapy for the maintenance treatment of asthma. During this study volunteers will receive the product approved in the US (Advair© Diskus©) and new test product OT329 Solis.Advair© Diskus© is identical in all but name to the product approved in the UK (Seretide© Accuhaler©).Lung inflammation and hypersensitivity results in narrowing of airways manifested as chest tightness in asthma patients. Inhaled long-acting Salmeterol administration results in keeping the airways open in the lungs which can be measured objectively through lung function tests. In this study we will investigate the effects of 3 single different doses of Advair© Diskus© and 1 single dose of test product OT329 Solis on various lung function parameters in subjects with asthma. From this data it will be determined that in comparable doses the test product OT329 Solis provides equivalent effect on lung function (airway opening) as the reference product Advair.This is a multi-centre study. It is anticipated that 48 volunteers with asthma will be enrolled to ensure 40 volunteers complete the study. Each volunteer will participate in 4 treatment periods separated by at least 5 days. In each treatment period the volunteer will receive single treatment on Day 1 and discharged from the unit on the same day. The total volume of blood to be taken will be no more than 15 ml for the whole study per subject.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/1083

• Date of REC Opinion

  7 Sep 2011

• REC opinion

  Further Information Favourable Opinion