CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
Salmeteroldrug
Likely dose
Salmeterol 50 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01536587
NCT01536587Phase 4Completed

Effects of Bronchodilatation With Salmeterol on the Autonomic Nervous System

GlaxoSmithKline·interventional·Posted Feb 22, 2012·Updated Apr 11, 2014

In Brief

A Phase 4 clinical trial evaluating Salmeterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32 subjects is planned to be enrolled.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2012
Enrollment StartJul 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.4 years ago

Interventions

Salmeteroldrug

At visit 1 the sympathetic activity will be registered using microneurographic recordings of efferent muscle sympathetic nerve activity (MSNA) in the peroneal nerve and respiration over 2 hours, after 20 minutes of recording, 1 dose of placebo will be administered and after a further recording period of 45 minutes a dose of salmeterol 50 µg will be administered which will be followed by a further period of data registration. At visit 2 following 4 weeks of inhaled treatment with salmeterol the same procedures will be performed but a placebo inhalation will not be performed.