Randomized Controlled Crossover Trial of a New Oscillatory Device as Add-On Therapy for COPD

Figures & data

Figure 1.  A schemata of the pulse device used in the study. A: Constant airflow inlet; B: Oscillating airflow outlet into patient's mouth.

Figure 2.  Screening, randomization, and follow up.

Figure 3.  Flow chart of the study.

Table 1.  Baseline characteristics of patients

Characteristic	Group 1 Oscillatory Device Control	Group 2 Control-Oscillatory Device
N	11	11
Age	67.7 ± 2.6	69.0 ± 1.9
Sex (M:F ratio)	8 : 3	10 : 1
Post-bronchodilator FEV1 (L) (% predicted)	1.3 ± 0.1 (49.6 ± 3.6)	1.5 ± 0.2 (52.6 ± 4.9)
GOLD stage
II –	5	6
III –	5	5
IV –	1
6MW (meters)	397 ± 31	426 ± 24
FVC (L) (% predicted)	2.3 ± 0.2	2.8 ± 0.2
	(72.5 ± 6.8)	(79.8 ± 3.4)
DLCO (% predicted)	60.8 ± 5.6	63.1 ± 5.8
RV/TLC (%)	59 ± 2.6	57 ± 2.4
IC (L) (% predicted)	1.88 ± 0.1	2.18 ± 0.2
	(72.4 ± 4.9)	(76.5 ± 5.7)
Quality of life score:
• Dyspnea	4.7 ± 0.5	5.2 ± 0.3
• Fatigue	4.6 ± 0.4	4.5 ± 0.4
• Emotional Function	5.3 ± 0.3	4.6 ± 0.4
• Mastery	5.1 ± 0.3	4.6 ± 0.5

Data is presented as mean ± SE, FEV1 = Forced expiratory volume in 1 sec., 6mw = 6-minute walk test, FVC = Forced vital capacity, DLCO = Diffusion capacity of lung, RV = Residual volume, TLC = Total lung capacity, IC = Inspiratory capacity.

Table 2.  Medical events during the trial

Medical Event	No of Patients	Treatment Arm	Group
COPD exacerbations/Pneumonia	2	OD	1
	2	Control OD	1
	3	Control	2
	4		2
Epigastric pain	1	Control	1
Mouth abscess	1	Control	2
Back pain & sore throat	1	Control	1
Gastroenteritis	1	OD	1

OD = Oscillatory device, Control = Control device.

Figure 4.  Percentage of patients responding (responders) to treatment with the oscillatory device. Percentage of patients with a clinically significant improvement (responders) following treatment with the oscillatory device. The following improvements were defined as clinically significant: >40 m in 6MW; >12% in FVC; >12% in FEV1; <0.05 in RV/TLC (abs); >1 in dyspnea score; >1 in mastery score.

Figure 5.  Changes in the 6-minute walk (6MW) test. Maximal change in the 6MW test compared to baseline for each patient with the sham device (left) and the oscillatory device (right).

Table 3.  Changes induced by oscillatory and control device treatments measured 1 and 2 weeks after the beginning of each round of treatment

	Oscillatory Device				Control Device				Oscillatory Device vs. Control
	1 week		2 weeks		1 week		2 weeks
	Mean ± SE (n)	p	Mean ± SE (n)	p	Mean ± SE (n)	p	Mean ± SE (n)	p	p
FVC (ml)	112 ± 86 (21)	0.21	201 ± 89 (21)	0.03	–13 ± 56 (18)	0.15	–141 ± 93 (20)	0.15	0.01
FEV1 (ml)	0 ± 30 (21)	0.99	44 ± 35 (21)	0.22	–13 ± 33 (18)	0.69	39 ± 65 (20)	0.56	0.94
RV/TLC (%)	–0.29 ± 1.4 (21)	0.36	–0.05 ± 2.7 (21)	0.67	1.5 ± 1.4 (18)	0.30	1.2 ± 1.1 (20)	0.30	0.67
IC (ml)	32 ± 73 (22)	0.67	122 ± 53 (22)	0.03	54 ± 66 (18)	0.42	24 ± 79 (20)	0.76	0.3
DLCO (%)	1.1 ± 0.7 (21)	0.27	0.4 ± 0.6 (21)	0.53	–0.4 ± 0.5 (18)	0.41	0.6 ± 0.5 (19)	0.27	0.301
6MW (meters)	51.6 ± 7.6 (20)	<0.001	61.8 ± 9.0 (21)	<0.001	1 ± 7.8 (18)	0.90	15.4 ± 10.4 (20)	0.16	<0.001
Dyspnea Score	N/A	N/A	1.0 ± 0.4 (11)	0.02	N/A	N/A	0.2 ± 0.3 (10)	0.70	0.084
Fatigue Score	N/A	N/A	0.6 ± 0.4 (11)	0.21	N/A	N/A	0.2 ± 0.3 (10)	0.70	0.525
Emotional Function Score	N/A	N/A	0.7 ± 0.3 (11)	0.08	N/A	N/A	0.5 ± 0.3 (10)	0.07	0.805
Mastery Score	N/A	N/A	1.0 ± 0.3 (11)	0.02	N/A	N/A	0.7 ± 0.3 (10)	0.07	0.524

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