Hyaluronic Acid Improves the Tolerability of Hypertonic Saline in the Chronic Treatment of Cystic Fibrosis Patients: A Multicenter, Randomized, Controlled Clinical Trial

Abstract Trial Design and Methods: Between December 2009 and July 2011, four cystic fibrosis (CF) centers in Italy participated in a randomized, double-blind, controlled clinical trial to test whether 7% hypertonic saline (HS) administered together with 0.1% hyaluronic acid (HA) was better tolerated...

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Veröffentlicht in:Journal of aerosol medicine Jg. 27; H. 2; S. 133 - 137
Hauptverfasser: Ros, Mirco, Casciaro, Rosaria, Lucca, Francesca, Troiani, Patrizia, Salonini, Elena, Favilli, Federica, Quattrucci, Serena, Sher, Daniel, Assael, Baroukh Maurice
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Los Angeles, CA SAGE Publications 01.04.2014
Mary Ann Liebert, Inc
Schlagworte:
Administration, Inhalation
Adolescent
Child
Cough - chemically induced
Cystic Fibrosis - diagnosis
Cystic Fibrosis - drug therapy
Cystic Fibrosis - physiopathology
Double-Blind Method
Drug Administration Schedule
Female
Forced Expiratory Volume
Humans
Hyaluronic Acid - administration & dosage
Hyaluronic Acid - adverse effects
Italy
Lung - drug effects
Lung - physiopathology
Male
Patient Compliance
Saline Solution, Hypertonic - administration & dosage
Saline Solution, Hypertonic - adverse effects
Taste
Time Factors
Treatment Outcome
Young Adult
Italy
clinical trial
inhaled therapy
cystic fibrosis
hypertonic saline
hyaluronan
ISSN:1941-2711, 1941-2703, 1941-2703
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Zusammenfassung:Abstract Trial Design and Methods: Between December 2009 and July 2011, four cystic fibrosis (CF) centers in Italy participated in a randomized, double-blind, controlled clinical trial to test whether 7% hypertonic saline (HS) administered together with 0.1% hyaluronic acid (HA) was better tolerated by patients who previously did not tolerate HS well on its own. Participants were CF patients at least 8 years old, in clinically stable conditions, with forced expiratory volume in 1 sec (FEV1) at least 50% predicted. Forty patients were recruited and randomized to receive either HS or HS plus HA (5 mL to be inhaled over 15 min, twice daily for 28 days). Primary endpoints were cough, throat irritation, salty taste, and overall acceptability, as assessed by each patient on a semiquantitative scale on a diary card. Secondary endpoint was FEV1 change at the end of treatment. Patients were randomized into randomly permuted blocks. The first and last doses were administered in hospital. In between, patients were treated at home. Patients, all caregivers, and the statistician who conducted the analysis (different from the one who generated the random list) were blinded to group assignment. Results: Severity of cough, throat irritation, and saltiness were more severe in patients treated with HS alone, both after the first inhalation and over the entire treatment period. Overall pleasantness was rated higher by patients treated with the combination product. All differences were highly significant. There were no changes in FEV1 between the first and last administrations. Five patients did not complete the study. Four patients (two from each group) withdrew because of cough or throat irritation. One more patient from the HS group withdrew because of a respiratory exacerbation at week 3. Conclusions: HS is currently a cornerstone in the treatment of CF patients. The addition of HA to HS reduces the prevalence and severity of cough, throat irritation, and saltiness and may improve compliance in patients who previously did not tolerate HS well on its own. Longer-term studies could further assess the benefit of chronic treatment.
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ISSN:1941-2711
1941-2703
1941-2703
DOI:10.1089/jamp.2012.1034