title: A randomized, placebo-controlled, double-blind trial on the management of post-infective cough by inhaled ipratropium and salbutamol administered in combination.
abstract: Post-viral cough is a type of cough originating from upper respiratory tract infections that persists after the infection is resolved. Although it was hypothesized that bronchodilators might have a role in the management of post-viral cough, a clear demonstration of their efficacy is missing. Therefore, we tested the efficacy of a combination of a β-agonist and an anticholinergic agent in reducing post-viral cough with a randomized, double blind, placebo controlled clinical trial. Patients were treated for 10 days with either a nebulized combination of salbutamol 1.875 mg/0.5 mL and ipratropium bromide 0.375 mg/0.5 mL, or a placebo, and followed up for another 10 days. Daytime and nighttime cough severity and spirometry testing were assessed before starting treatment, after 10 and 20 days. Ninety-two patients were randomized to receive placebo (n = 46) or the active treatment (n = 46); nine of them (4 in the placebo group, 5 in the active treatment group) dropped out from the study. Daytime and nighttime cough severity were significantly reduced in both groups during the study period, but the reduction was more prominent in the active treatment group vs. placebo after 10 days of treatment (P = 0.003 for day cough; P = 0.061 for night cough), whereas at the end of follow-up period cough severity was comparable between the two groups. Small but significant increases in spirometric parameters were observed in the active treatment vs. placebo group, although at the end of follow-up these values returned to be comparable to placebo. The frequency of adverse events was not significantly different between the two groups of patients. We concluded that a combination of a β-agonist and an anticholinergic agent can effectively reduce post-viral cough, and can thus represent a valid option for this type of cough.
authors.affiliation: Italian Association for Cough Study, Via Mazzini, 12, 40138 Bologna, Italy. Electronic address: alessandro.zanasi@aosp.bo.it.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Zanasi
authors.affiliation: Department of Biotechnology and Biosciences, University of Milan Bicocca, Piazza della Scienza, 2, 20126 Milan, Italy. Electronic address: marzia.lecchi1@unimib.it.
authors.forename: Marzia
authors.initials: M
authors.lastname: Lecchi
authors.affiliation: Pneumology Institute, S. Orsola-Malpighi Hospital, Via Massarenti, 9, 40138 Bologna, Italy. Electronic address: manuela.delfo@gmail.com.
authors.forename: Manuela
authors.initials: M
authors.lastname: Del Forno
authors.affiliation: Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Via Massarenti, 9, 40138 Bologna, Italy. Electronic address: elisa.fabbri0909@gmail.com.
authors.forename: Elisa
authors.initials: E
authors.lastname: Fabbri
authors.affiliation: Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Via Massarenti, 9, 40138 Bologna, Italy. Electronic address: marianna.mastroroberto@gmail.com.
authors.forename: Marianna
authors.initials: M
authors.lastname: Mastroroberto
authors.affiliation: Pneumology Institute, S. Orsola-Malpighi Hospital, Via Massarenti, 9, 40138 Bologna, Italy. Electronic address: mazzolini_massimiliano@hotmail.com.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Mazzolini
authors.affiliation: Pneumology Institute, S. Orsola-Malpighi Hospital, Via Massarenti, 9, 40138 Bologna, Italy. Electronic address: larapisani81@gmail.com.
authors.forename: Lara
authors.initials: L
authors.lastname: Pisani
authors.affiliation: Department Public Health, AUSL Bologna, Via del Seminario, 1, 40068 San Lazzaro di Savena, BO, Italy. Electronic address: paolo.pandolfi@ausl.bologna.it.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pandolfi
authors.affiliation: Pneumology Institute, S. Orsola-Malpighi Hospital, Via Massarenti, 9, 40138 Bologna, Italy. Electronic address: stefano.nava@unibo.it.
authors.forename: Stefano
authors.initials: S
authors.lastname: Nava
authors.affiliation: Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Via Massarenti, 9, 40138 Bologna, Italy. Electronic address: antonio.morselli@unibo.it.
authors.forename: Antonio Maria
authors.initials: AM
authors.lastname: Morselli-Labate
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003371:Cough / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012141:Respiratory Tract Infections / Q000150:complications / Q000821:virology; D013147:Spirometry; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D009241:Ipratropium; D000420:Albuterol
keywords: Ipratropium bromide; Ipratropium bromide (PubChem CID: 31098); Night cough; Post-viral cough; Salbutamol; Salbutamol (PubChem CID: 2083); Upper respiratory tract infection