Efficacy and safety of topical combinations of ipratropium and xylometazoline for the treatment of symptoms of runny nose and nasal congestion associated with acute upper respiratory tract infection.
BACKGROUND
Rhinorrhea and nasal congestion are simultaneous symptoms associated with the common cold. This study investigated the efficacy and safety of a combination nasal spray of ipratropium and xylometazoline for simultaneous treatment of these symptoms.


METHODS
The trial was a multicenter double-blind, parallel-group, randomized design on patients with common cold symptoms. Patients scored symptoms of runny nose and nasal congestion and recorded adverse events in a diary for up to 7 days. Patients also recorded tissue use. The five test treatments consisted of ipratropium, 0.6 mg/mL, and xylometazoline, 1.0 mg/mL; ipratropium, 0.6 mg/mL, and xylometazoline, 0.5 mg/mL; ipratropium, 0.6 mg/mL; xylometazoline, 1.0 mg/mL; and placebo solution.


RESULTS
Eight hundred sixty-four patients were screened and 786 patients received treatment. One day after treatment there was a clear separation between the scores for the placebo and ipratropium treatment groups for rhinorrhea and between the placebo and xylometazoline treatment groups for congestion. Both ipratropium/xylometazoline 1.0 and ipratropium/xylometazoline 0.5 treatments were superior to xylometazoline with respect to rhinorrhea (p < 0.0001) and superior to ipratropium with respect to nasal congestion scores (p < 0.001). Both the ipratropium combination treatments had significantly lower tissue use than the xylometazoline treatment group (p < 0.0001). Adverse events were distributed equally between the treatments, except mucus tinged with blood, epistaxis, nasal passage irritation, and nasal dryness, which had a higher incidence in the three groups that received medicines containing ipratropium.


CONCLUSIONS
The results indicate that a combination medicine of ipratropium and xylometazoline is safe and effective for treatment of rhinorrhea and nasal congestion associated with common cold.
Eccles
Ronald
R
Common Cold Centre, Cardiff School of Biosciences, Cardiff University, United Kingdom. eccles@cf.ac.uk
Pedersen
Anette
A
Regberg
Dan
D
Tulento
Heikki
H
Borum
Peter
P
Stjärne
Pär
P
D000287:Administration, Topical; D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018680:Cholinergic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D009241:Ipratropium / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000008:administration & dosage* / Q000627:therapeutic use; D012141:Respiratory Tract Infections / Q000150:complications*; D012220:Rhinitis / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D018680:Cholinergic Antagonists; D007093:Imidazoles; D014663:Nasal Decongestants; D009241:Ipratropium; C009695:xylometazoline