Trial Outcomes & Findings for Effects of Salmeterol on Autonomic Nervous System (NCT NCT01536587)
NCT ID: NCT01536587
Last Updated: 2014-04-11
Results Overview
Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats \[bursts/100 heart beats\]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).
COMPLETED
PHASE4
32 participants
Baseline and 2 hours (Week 0)
2014-04-11
Participant Flow
At Visit 1, a complex data registration was performed during which placebo and 50 micrograms (µg) salmeterol via SEREVENT DISKUS inhaler was administered sequentially. Following Visit 1, participants were treated with salmeterol 50 µg twice daily (BID) via DISKUS inhaler for 4 weeks.
Participant milestones
| Measure |
Salmeterol 50 µg BID
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Salmeterol 50 µg BID
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Effects of Salmeterol on Autonomic Nervous System
Baseline characteristics by cohort
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Age, Continuous
|
61.19 Years
STANDARD_DEVIATION 8.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 hours (Week 0)Population: ITT-MSNA Population: all participants who received at least one dose of study medication and who had a valid data registration period of the primary endpoint.
Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats \[bursts/100 heart beats\]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0)
|
-1.3 Bursts/100 heart beats
Standard Deviation 8.13
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per 100 heart beats (bursts/100 heart beats). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=12 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4
|
-3.1 Bursts/100 heart beats
Standard Deviation 11.58
|
SECONDARY outcome
Timeframe: Baseline and 2 hours (Week 0)Population: ITT-MSNA Population
Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per minute \[bursts/minute\]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0)
|
0.3 Bursts/minute
Standard Deviation 5.60
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per minute (bursts/minute). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=12 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4
|
0.5 Bursts/minute
Standard Deviation 7.58
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
Heart rate variability (HRV) refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0, n=32
|
-1.7 ms
Standard Deviation 26.4
|
|
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)
Change from Baseline to Week 4, n=31
|
0.1 ms
Standard Deviation 53.9
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0
|
1.2 ms
Standard Deviation 22.5
|
|
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)
Change from Baseline to Week 4
|
-12.1 ms
Standard Deviation 29.5
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0, n=32
|
-11.5 ms
Standard Deviation 36.3
|
|
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)
Change from Baseline to Week 4, n=31
|
-5.2 ms
Standard Deviation 96.1
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0
|
-10.6 ms
Standard Deviation 26.4
|
|
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)
Change from Baseline to Week 4
|
-32.5 ms
Standard Deviation 47.4
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms\^2). Change from Baseline were calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to 2 hours, Week 0, n=32
|
-123.8 ms^2
Standard Deviation 1588.4
|
|
Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to Week 4, n=31
|
-390.1 ms^2
Standard Deviation 1463.3
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population
HRV refers to the complex beat-to-beat (N-N) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms2). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation), respectively.
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0
|
220.7 ms^2
Standard Deviation 1038.2
|
|
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)
Change from Baseline to Week 4
|
-248.1 ms^2
Standard Deviation 755.2
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms\^2). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to 2 hours, Week 0, n=32
|
-457.9 ms^2
Standard Deviation 1591.6
|
|
Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to Week 4, n=31
|
817.5 ms^2
Standard Deviation 8754.6
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms\^2). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0
|
-372.1 ms^2
Standard Deviation 1194.4
|
|
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)
Change from Baseline to Week 4
|
-840.2 ms^2
Standard Deviation 1491.5
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power-VLF)\*100). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to 2 hours, Week 0, n=32
|
8.4 percent change
Standard Deviation 14.5
|
|
Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to Week 4, n=31
|
2.5 percent change
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power-VLF)\*100). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0
|
10.8 percent change
Standard Deviation 14.6
|
|
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)
Change from Baseline to Week 4
|
11.6 percent change
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power-VLF)\*100). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to 2 hours, Week 0, n=32
|
-8.4 percent change
Standard Deviation 14.5
|
|
Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to Week 4, n=31
|
-2.5 percent change
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population
HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power-VLF)\*100). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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)
Change from Baseline to 2 hours, Week 0
|
-10.8 percent change
Standard Deviation 14.6
|
|
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)
Change from Baseline to Week 4
|
-11.6 percent change
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to 2 hours, Week 0, n=32
|
3.7 beats per minute (bpm)
Standard Deviation 4.2
|
|
Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to Week 4, n=31
|
3.9 beats per minute (bpm)
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population
Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Change from Baseline to 2 hours, Week 0
|
4.4 beats per minute (bpm)
Standard Deviation 4.7
|
|
Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Change from Baseline to Week 4
|
4.9 beats per minute (bpm)
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to 2 hours, Week 0, n=31
|
0.1 ms/mmHg
Standard Deviation 1.9
|
|
Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to Week 4, n=29
|
0.2 ms/mmHg
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=17 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Change from Baseline to 2 hours, Week 0
|
0.28 ms/mmHg
Standard Deviation 2.2
|
|
Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Change from Baseline to Week 4
|
0.44 ms/mmHg
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to 2 hours, Week 0, n=32
|
-0.04 L
Standard Deviation 0.23
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Change from Baseline to Week 4, n=31
|
-0.04 L
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=18 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Change from Baseline to 2 hours, Week 0
|
-0.05 L
Standard Deviation 0.26
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Change from Baseline to Week 4
|
-0.08 L
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
Systolic and diastolic BP was manually measured. Change in BP after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=31 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4
Systolic: Change from Baseline to 2 hours, Week 0
|
3.6 mmHg
Standard Deviation 12.3
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4
Systolic: Change from Baseline to Week 4
|
3.7 mmHg
Standard Deviation 15.7
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4
Diastolic: Change from Baseline to 2 hours, Week 0
|
1.9 mmHg
Standard Deviation 6.7
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4
Diastolic: Change from Baseline to Week 4
|
0.7 mmHg
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
Respiratory rate is defined as the number of breaths taken within a set amount of time (typically within 60 seconds). Change in respiratory rate after salmeterol inhalation is expressed in terms of respiratory rate (breaths) per minute (min). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0, n=32
|
-0.5 breaths per minute
Standard Deviation 1.6
|
|
Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4, n=31
|
-0.1 breaths per minute
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Tidal volume is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 milliliters or 7 milliliters per kilogram of body weight). Change in tidal volume after salmeterol inhalation is expressed in terms of milliliters (mL). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0, n=30
|
60.4 mL
Standard Deviation 118.0
|
|
Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4, n=24
|
55.6 mL
Standard Deviation 183.7
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Respiratory minute volume is defined as the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. Change in respiratory minute volume after salmeterol inhalation is expressed in terms of milliliters per minute (mL/min). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0, n=30
|
572.0 mL/min
Standard Deviation 1529.7
|
|
Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4, n=24
|
671.4 mL/min
Standard Deviation 2963.3
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma norepinephrine) after salmeterol inhalation is expressed in terms of nanogramms per liter (ng/L). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0, n=26
|
-42.4 ng/L
Standard Deviation 103
|
|
Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4, n=29
|
-5.7 ng/L
Standard Deviation 133
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma epinephrine) after salmeterol inhalation is expressed in terms of nanograms per milliliter (ng/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0, n=26
|
6.7 ng/mL
Standard Deviation 12.7
|
|
Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4, n=29
|
-0.3 ng/mL
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (BNP) after salmeterol inhalation is expressed in terms of picograms per milliliter (pg/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=27 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0
|
2.4 pg/mL
Standard Deviation 7.0
|
|
Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4
|
-6.1 pg/mL
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: Safety Population: all participants included in the study who received at least one dose of study medication. Only those participants available at the indicated time points were assessed.
Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. Change in SpO2 after salmeterol inhalation is expressed in terms of percent. Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0, n=32
|
-0.2 percent
Standard Deviation 1.1
|
|
Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4, n=31
|
-0.5 percent
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, 2 hours (Week 0), and Week 4Population: Safety Population. Only those participants available at the indicated time points were assessed.
Transcutaneous carbon dioxide monitoring is a noninvasive way of continuously measuring the tension of these gases in the skin. This methodology provides a continuous noninvasive estimation of the arterial CO2 value. Change in tCO2 after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 \[Visit 1, after salmeterol inhalation\]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4
Change from Baseline to 2 hours, Week 0, n=32
|
-0.94 mmHg
Standard Deviation 2.19
|
|
Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4
Change from Baseline to Week 4, n=31
|
-0.82 mmHg
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
FVC is defined as the volume of air that can be forcibly blown out from the lungs after a full inspiration. FRC is defined as the volume of air present in the lungs, specifically the parenchyma tissues, at the end of a passive expiration. TLC is defined as the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to VC plus the RV and is approximately 5800 milliliters. RV is defined as the amount of gas remaining in the lungs at the end of a maximal exhalation. All parameters describing lung function are expressed in terms of liters (L). Lung function (FVC, FRC \[body and helium\], TLC, and RV) was evaluated at Baseline (Week 0, \[Visit 1, before any inhalation\]) and at Week 4 (Visit 2, after salmeterol inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
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
FVC at Baseline, Week 0, n=32
|
2.60 L
Standard Deviation 0.7
|
|
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
FVC at Week 4, n=31
|
2.64 L
Standard Deviation 0.7
|
|
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
FRC (body) at Baseline, Week 0, n=32
|
4.65 L
Standard Deviation 1.3
|
|
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
FRC (body) at Week 4, n=27
|
3.67 L
Standard Deviation 1.8
|
|
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
FRC (helium) at Baseline, Week 0, n=24
|
3.64 L
Standard Deviation 1.0
|
|
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
FRC (helium) at Week 4, n=24
|
3.38 L
Standard Deviation 0.8
|
|
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
TLC at Baseline, Week 0, n=32
|
6.61 L
Standard Deviation 1.4
|
|
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
TLC at Week 4, n=27
|
5.67 L
Standard Deviation 1.8
|
|
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
RV at Baseline, Week 0, n=32
|
3.90 L
Standard Deviation 1.3
|
|
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
RV at Week 4, n=27
|
2.90 L
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT Population. Only those participants available at the indicated time points were assessed.
Diastolic dysfunction refers to the decline in performance of one (usually the left ventricle) or both (left and right) ventricles during diastole. The number of participants with diastolic dysfunction on echocardiography was evaluated at Baseline (Week 0, \[Visit 1, before any inhalation\]) and at Week 4 (Visit 2, after salmeterol inhalation).
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4
Baseline: Diastolic dysfunction: Yes, n=32
|
3 participants
|
|
Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4
Baseline: Diastolic dysfunction: No, n=32
|
29 participants
|
|
Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4
Week 4: Diastolic dysfunction: Yes, n=31
|
5 participants
|
|
Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4
Week 4: Diastolic dysfunction: No, n=31
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arterial stiffness occurs as a consequence of age and arteriosclerosis. Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. PWV was evaluated in terms of meters per second (m/s). PWV after salmeterol inhalation at Baseline (Week 0, \[Visit 1, before any inhalation\]) and at Week 4 (Visit 2, after inhalation of salmeterol) was assessed.
Outcome measures
| Measure |
Salmeterol 50 µg BID
n=32 Participants
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Arterial Stiffness at Baseline (Week 0) and at Week 4
PWV at Baseline, Week 0, n=30
|
9.2 m/s
Standard Deviation 2.1
|
|
Arterial Stiffness at Baseline (Week 0) and at Week 4
PWV at Week 4, n=29
|
8.8 m/s
Standard Deviation 2.2
|
Adverse Events
Salmeterol 50 µg BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Salmeterol 50 µg BID
n=32 participants at risk
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
|
|---|---|
|
Cardiac disorders
Palpitations
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Swollen tongue
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Gingivitis
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
2/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Paraesthesia
|
6.2%
2/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
3.1%
1/32 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER