A pilot clinical trial to determine the safety and efficacy of aerosolized hyaluronan as a treatment for COPD

Figures & data

Table 1 Patient characteristics

Characteristic	CTX-100	Placebo
Number of subjects	8	3
Age (years)	63±8a	52±11a
Race	7 white, 1 African-American	3 white
FEV1 (L)	1.84±0.45a	1.77±0.44a
DLCO (mL/min/mmHg)	16.6±8.0a	19.6±0.8a
Total lung capacity (L)	7.1±2.1a	5.9±0.5a
Smoking Hx	>10 pack-years	>10 pack-years
Active smokers	None	None
Inhaled corticosteroids	4	None
Recent exacerbations	None	None

Note:

a Mean ± SD.

Abbreviations: DLCO, carbon monoxide diffusing capacity; FEV₁, forced expiratory volume in 1 second; Hx, history; SD, standard deviation.

Table 2 FEV₁ (liters ± SD)

Time point	CTX-100a	Placebob	p-value
Pretreatment	1.84±0.45	1.77±0.44	0.92
Week 1	1.80±0.42	1.75±0.38	0.92
Week 2	1.72±0.33	1.73±0.31	1.0
Week 3	1.90±0.51	1.70±0.29	0.36

Note:

a N=8,

b N=3.

Abbreviations: FEV₁, forced expiratory volume in 1 second; SD, standard deviation.

Table 3 DLCO (mL/min/mmHg ± SD)

Time point	CTX-100a	Placebob	p-value
Pretreatment	16.6±8.0	19.6±0.8	0.54
Week 1	16.2±7.8	19.8±1.5	0.46
Week 2	15.6±6.9	19.8±1.0	0.34

Note:

a N=8,

b N=3.

Abbreviations: DLCO, carbon monoxide diffusing capacity; SD, standard deviation.

Table 4 Adverse events

CTX-100	Placebo
Migrainea	Difficulty breathinga
Joint painb	Lung paina
Chest congestionb	Profuse sweatinga
Feverb	Coughingb
Intermittent coughb	Light-headednessb
Pitting edemab
Diarrheab
Light-headednessb

Note:

a Moderate,

b mild.

Figure 1 Graph showing progressive reduction in plasma DID levels following treatment with CTX-100 (r=–0.98; p=0.02).

Note: Data are expressed as mean ± SEM.

Abbreviations: DID, desmosine and isodesmosine; SEM, standard error of the mean.

Figure 2 Graph showing significant negative correlation between sputum DID levels and time following treatment with CTX-100 (r=–0.97; p=0.03).

Note: Data are expressed as mean ± SEM.
Abbreviations: DID, desmosine and isodesmosine; SEM, standard error of the mean.