Effects of Salmeterol on Autonomic Nervous System

Phase 4 Completed 32 enrolled GlaxoSmithKline

NaSingle-groupSingle-blindTreatment

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.

Timeline

Start: 2012-07
Primary completion: 2012-11
Completion: 2012-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Salmeterol 50 µg BID; p = 0.5062; paired t-Test, 2-sided NCT01536587 ↗

paper Change in MSNA (bursts/100 heart beats) following acute administration of salmeterol did not differ significantly from the change following placebo (-1.96 ± 9.81 vs. -0.65 ± 9.07; p = 0.51) PMID 25924990 ↗

Publications

Haarmann H, Mohrlang C, Tschiesner U, Rubin DB, Bornemann T, Ruter K, Bonev S, Raupach T, Hasenfuss G, Andreas S. Inhaled beta-agonist does not modify sympathetic activity in patients with COPD. BMC Pulm Med. 2015 Apr 30;15:46. doi: 10.1186/s12890-015-0054-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Salmeterol	Other / unclassified	50 ug	Inhaled