Effects of intranasal xylometazoline, alone or in combination with ipratropium, in patients with common cold

Abstract

Background:

Common cold is one of the most prevalent conditions that family doctors encounter. One of the first symptoms to occur is nasal congestion, which can have a negative impact on daily life and prompts many patients to seek treatment for relief. Xylometazoline nasal spray (Otrivin^*) is a topical decongestant that has been used successfully for many years and is generally recognized as an effective and safe therapy. However, most studies have investigated its clinical efficacy in healthy patients and few have included patients with common cold.

* Otrivin® is a registered trademark of Novartis AG, Basel, Switzerland.

Scope:

To review the published clinical efficacy and safety of xylometazoline alone and in combination in the management of nasal congestion in patients with common cold. Literature searches of PubMed and the Cochrane Library were conducted to obtain published open or blinded, randomized, placebo- or active-controlled studies on the use of xylometazoline hydrochloride for the symptomatic relief of nasal congestion in patients with common cold. Searches included papers published in English only, up to September 2009.

Findings:

Despite the small number of studies identified in common cold (n = 4), as per search criteria defined, intranasal xylometazoline quickly and effectively relieved nasal congestion. When used alone, xylometazoline had a clinically relevant decongestant effect that was significantly superior for up to 10 hours compared with placebo. The superior decongestant effect with xylometazoline led to high patient satisfaction with treatment. When used in combination with ipratropium bromide, nasal congestion and rhinorrhoea were treated simultaneously, leading to significantly higher patient general impression scores compared with either agent used alone. Xylometazoline was well tolerated, with generally mild to moderate nasal-related side effects (e.g. epistaxis in 3.4% of patients, and blood-tinged mucus in 10–26% of patients) that were easily resolved; the most frequently reported non-nasal AEs were headache (3.4%) and period pain (10.3%); no cases of sedation were reported. As expected, no rhinitis medicamentosa or rebound congestion was noted with short-term use (<10 days). No clinically important differences in ciliary motility and mucociliary clearance were observed. Xylometazoline does not result in sympathomimetic systemic side effects seen with oral decongestants (e.g. pseudoephedrine, phenylephrine).

Conclusions:

The few studies available in common cold suggest that intranasal xylometazoline provides fast and effective relief of nasal congestion and is well tolerated. When xylometazoline is used in combination with ipratropium, patients with common cold experience the additive benefit of nasal congestion and rhinorrhoea being treated simultaneously.

Keywords::

• Common cold
• Decongestant
• Intranasal
• Nasal congestion
• Xylometazoline

Transparency

Declaration of funding

This study was sponsored by Novartis Consumer Health, Inc., which markets the reviewed drug (xylometazoline; Otrivin/Otrivin Complete/Otrivin Comp/Otrivin Duo/OtriDuo) worldwide.

Declaration of financial/other relationships

K.M. and S.C. were both employees of Novartis Consumer Health at the time of the manuscript preparation. R.E. has worked in the past as a consultant with Novartis Consumer Health, Inc. and had also received a grant for research, but has received no financial remuneration for authorship of this review.

Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she is the recipient of research grants from Dyax, Dynova and Meda; is a consultant to Cornerstone, Dynova; and is on the speakers bureau for AstraZeneca and ViroPharma. Peer Reviewer 2 has disclosed that he/she has no relevant financial relationships.

Acknowledgements

The draft of this manuscript was prepared by a professional medical writer (Deborah Nock, DPP-Cordell Ltd), with full review and approval by all authors; this support was funded by Novartis Consumer Health.

Notes

* Otrivin® is a registered trademark of Novartis AG, Basel, Switzerland.

† Otrivin Complete/Otrivin Comp/Otrivin Duo/OtriDuo are registered trade names of Novartis Consumer Health SA. The list of trade names is not exhaustive and some additional trade names exist and are registered in EU countries.