Phase 4
N=32
Effects of Salmeterol on Autonomic Nervous System
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01536587 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0) — -1.3 Bursts/100 heart beats — p=0.5062
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Salmeterol (Drug)
- Age
- Adult, Older Adult · 41+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0) |
-1.3 | 0.5062 |
| SECONDARY Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4 |
-3.1 | — |
| SECONDARY Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0) |
0.3 | — |
| SECONDARY Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4 |
0.5 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT Population) |
-1.7; 0.1 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
1.2; -12.1 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT Population) |
-11.5; -5.2 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
-10.6; -32.5 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population) |
-123.8; -390.1 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
220.7; -248.1 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population) |
-457.9; 817.5 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
-372.1; -840.2 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population) |
8.4; 2.5 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
10.8; 11.6 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population) |
-8.4; -2.5 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency Power (HF) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
-10.8; -11.6 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population) |
3.7; 3.9 | — |
| SECONDARY Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
4.4; 4.9 | — |
| SECONDARY Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population) |
0.1; 0.2 | — |
| SECONDARY Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
0.28; 0.44 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population) |
-0.04; -0.04 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population) |
-0.05; -0.08 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4 |
3.6; 3.7; 1.9; 0.7 | — |
| SECONDARY Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4 |
-0.5; -0.1 | — |
| SECONDARY Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4 |
60.4; 55.6 | — |
| SECONDARY Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4 |
572.0; 671.4 | — |
| SECONDARY Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4 |
-42.4; -5.7 | — |
| SECONDARY Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4 |
6.7; -0.3 | — |
| SECONDARY Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4 |
2.4; -6.1 | — |
| SECONDARY Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4 |
-0.2; -0.5 | — |
| SECONDARY Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4 |
-0.94; -0.82 | — |
| SECONDARY Lung Function (Forced Vital Capacity [FVC], Functional Residual Capacity [FRC; Body and Helium], Total Lung Capacity [TLC], and Residual Volume [RV]) at Baseline (Week 0) and at Week 4 |
2.60; 2.64; 4.65; 3.67; 3.64; 3.38 | — |
| SECONDARY Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4 |
3; 29; 5; 26 | — |
| SECONDARY Arterial Stiffness at Baseline (Week 0) and at Week 4 |
9.2; 8.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- COPD of GOLD Class II or III with a post-bronchodilator spirometry forced expiratory volume in one second (FEV1) 1 antihypertensive drug
- Clinically evident polyneuropathy
- Diabetes mellitus necessitating any pharmacological therapy
- Severe concomitant disease (likely to reduce life expectancy to less than 3 years)
- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant neurological, psychiatric, renal, hepatic, immunological, endocrine or haematological abnormality that is uncontrolled
Data sourced from ClinicalTrials.gov (NCT01536587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.