Table 2.
Studies of the clinical use of nebulised hyaluronic acid in chronic obstructive pulmonary disease and asthma in humans.
| First Author (Year) |
Study Design | N; Male (%); Mean Age | Inclusion and Exclusion Criteria | Intervention | Results | Adverse Events |
|---|---|---|---|---|---|---|
| COPD | ||||||
| Cantor (2017) | Prospective, randomised, double-blind, placebo-controlled | 11; no data; 60 |
Inclusion: COPD patients with GOLD grades 2 and 3 with moderate airway obstructions and at least a 10-pack/year history of cigarette smoking. Exclusion: no active smoking. |
Each patient self-administered 3 mL of aerosolised inhalation solution (0.01% of HA in 3 mL of IS or 3 mL of IS alone) twice-daily for 14 days. | Measurements of desmosine and DID in plasma from HA-treated patients indicated a progressive decrease over a 3-week period following initiation of the treatment. There was no significant reduction in the placebo group. Patients receiving IS showed no reduction in DID. Measurements of sputum in the HA-treated group revealed a progressive decrease in DID. |
HA was well-tolerated and did not involve adverse events requiring the cessation of treatment. |
| ASTHMA | ||||||
| Petrigni (2006) |
Prospective, randomised, cross-over, single-blind |
14; 11 (78.6%); 21.36 |
Inclusion: patients with mild persistent bronchial asthma. Exclusion: no active smoking, patients participated in the study out of the season of their individual allergy. |
A single dose of IS as placebo (4 mL) or HA (iso-osmolar solution containing 0.3% of HA) was administered by aerosol in 2 nonconsecutive days, 30 min prior to the beginning of the challenge (10 min free running). |
Pretreatment induced with aerosolised HA determined partial but clear protection on the FEV1 reduction due to the bronchoconstriction exercise. | No data. |
| Kunz (2005) |
Prospective, randomised double-blinded placebo-controlled crossover | 16; 6 (37.5%); no data |
Inclusion: clinical history of asthma, clinically stable lung disease 2 weeks prior to the screening, FEV1 ≥ 50% predicted value, concentration methacholine at which the patient had a fall in FEV1 of 20% of <8 mg/mL and > 15% fall from baseline FEV1 within 30 min after an exercise challenge. Exclusion: nonsmoking. |
On 2 separate visits, an exercise challenge was performed 15 min post-inhalation of either HA (3 mL 0.1% in PBS) or placebo (3-mL PBS). The wash-out period between both treatment days was 7–14 days. |
The maximum fall in FEV1 following the exercise challenge was not significantly different between HA vs. placebo, as was the area under the time-response curve. | HA was well-tolerated, and no serious adverse events were reported. |
COPD, chronic obstructive pulmonary disease; GOLD, global initiative for chronic obstructive lung disease; HA, hyaluronic acid; IS, isotonic saline; DID, isodesmosine; FEV1, forced expiratory volume in one second and PBS, phosphate-buffered saline.