Combined intranasal ipratropium bromide and oxymetazoline in experimental rhinovirus infection.
The topical anticholinergic ipratropium bromide and topical decongestant oxymetazoline were tested to determine whether oxymetazoline alone and the combination were well tolerated and reduced rhinorrhea and middle ear pressure abnormalities during experimental rhinovirus infection. The study was double-bind, placebo-controlled, and double dummy in design. Healthy volunteers (n = 109) with low serum neutralizing antibody titer (< or = 1:2) were. Treatments inoculated with rhinovirus (type 39 or Hank's strain) and randomized to treatment with ipra-tropium bromide 0.06% two sprays per nostril (84 micrograms per treatment) and oxymetazoline 0.05% two sprays per nostril, oxymetazoline alone, or placebo. Treatments were self administered twice daily for 5 days beginning 1 day after rhinovirus inoculation. The overall infection rate was 83% and of those infected, 88% felt that they had a cold. During the 3-hour period after dosing, the increase in nasal discharge was significantly lower in the combined ipratropium and oxymetazoline (0.13 +/- 0.17 gm/3 hr, mean +/- SE) than after oxymetazoline alone (0.60 +/- 0.18 gm/3 hr) or vehicle (0.73 +/- 0.18 gm/3 hr). Over the 5-day observation period, total daily nasal discharge also tended to be lower in the ipratropium plus oxymetazoline group (3.67 +/- 0.70 gm/24 hr, mean +/- SE) compared to oxymetazoline (5.61 +/- 0.73: 35% reduction) or the vehicle (5.04 +/- 0.73; 27% reduction) recipients, but the differences were not statistically significant. Subjective assessments of rhinorrhea indicated that the severity of rhinorrhea was significantly better among patients receiving oxymetazoline alone or with ipratropium compared to the vehicle. No significant difference in the cumulative frequencies of middle ear pressure abnormalities (27-31%) were found among the treatment groups. Oxymetazoline does not consistently stimulate or decrease nasal mucus production, and ipratropium added to oxymetazoline is well tolerated and reduces rhinorrhea during experimental rhinovirus infection.
Pitkäranta
A
A
University of Virginia School of Medicine, Charlottesville 22908, USA.
Wecker
M T
MT
Korts
D C
DC
Hayden
F G
FG
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004338:Drug Combinations; D004432:Ear, Middle / Q000187:drug effects / Q000503:physiopathology; D005260:Female; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D009297:Nasal Mucosa / Q000187:drug effects / Q000378:metabolism; D010109:Oxymetazoline / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010850:Picornaviridae Infections / Q000188:drug therapy* / Q000503:physiopathology; D011312:Pressure; D012229:Rhinovirus
D004338:Drug Combinations; D010109:Oxymetazoline; D009241:Ipratropium