DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasal Obstruction Present Finding

Intervention: oxymetazoline (Drug); Placebo nasal spray (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Torpong Thongngarm, M.D., Principal Investigator, Affiliation: Mahidol University
Panitan Pradubpongsa, M.D., Study Chair, Affiliation: Mahidol University
Paraya Assanasen, M.D., Study Chair, Affiliation: Mahidol University
Pongsakorn Tantilipikorn, M.D., Study Chair, Affiliation: Mahidol University

Summary

Background Allergic rhinitis is a common health problem with a worldwide prevalence is 10-25%, and poses significant impact on the quality of life of the patients. In Thailand, the prevalence of allergic rhinitis in the general population is 13. 5%, of which the frequency of allergic rhinitis increased from 23% to 38% in the children, and 61. 9% in the graduate students. Despite intranasal steroid being the current first-line treatment of patients with allergic rhinitis, only 60% of patients achieve excellent control. Persistent nasal congestion is the major symptom which is difficult to control in these patients. Data are limited about efficacy and safety of the additional use of 0. 05% intranasal oxymetazoline hydrochloride (OXY) for persistent nasal congestion that does not adequately respond to recommended doses of intranasal steroid (INS) and oral antihistamine(OAH). Objective To determine the efficacy and safety of the additional use of OXY for persistent nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately controlled by combination treatment with INS and OAH. Methods The investigators performed a 6-week, randomized, double blind, placebo controlled, clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom inadequately controlled by combination treatment with INS and oral antihistamine (OAH). After an initial screening, qualified individuals were randomized into 2 groups including the treatment group and the control group. The treatment group received the INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus OXY (2 puffs in each nostril twice daily) The control group received INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus placebo (2 puffs in each nostril twice daily).

Clinical Details

Official title: Effectiveness of Oxymetazoline Added on Intranasal Steroid in the Treatment of Allergic and Nonallergic Rhinitis With Persistent Nasal Obstruction

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction

Secondary outcome: The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline

Detailed description: All participants will continue medications for 4 weeks, then stop using interventional medication and still take INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) for 2 more weeks. Then, all participants will come for the last visit to see whether rebound nasal symptoms occur. Participants will be asked to record nasal symptom diary card, and nasal peak inspiratory flow. Rhinoconjunctivitis Quality of life Questionnaire (Rcq) will be recorded during visit.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient 18 years of age or greater

- Diagnosis with allergic or nonallergic rhinitis with persistent nasal obstruction

- Being treated with intranasal steroid and oral antihistamine

Exclusion Criteria:

- Underlying disease of hypertension

- Use oral or nasal decongestant 7 days prior to entering the study

- Nasal polyp or significant deviated nasal septum

- Respiratory tract infection 14 days prior to entering the study

Locations and Contacts

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information

Starting date: April 2013
Last updated: January 3, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017