Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Cost Analysis of Steroid Spray in Treatment of Otitis Media With Effusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03590912
Recruitment Status : Not yet recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Lumbini Medical College

Brief Summary:
We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Drug: Fluticasone Nasal Drug: Anti Histamine plus Nasal decongestents Drug: Steroid Drug Phase 4

Detailed Description:

Treatment groups would be:

  1. Wait and watch
  2. Fluticasone intranasal spray
  3. oxymetaxoline drops + cetrizine
  4. Short term oral steroids

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Cost Analysis of Steroid Spray in Treatment of Otitis Media With Effusion (OME) Compared to That of Antibiotic, Antihistaminic, and Nasal Decongestant
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Wait and watch
Wait and watch for 1 month
Experimental: Fluticasone spray
Standard dose of fluticasone nasal spray daily for one month
Drug: Fluticasone Nasal
Dose to be added.

Experimental: Oral histaminics and oxymetazoline drops
Standard dose of oral cetirizine for a month plus oxymetazoline nasal drops for two weeks
Drug: Anti Histamine plus Nasal decongestents
Oral cetirizine, standard dose for 4 weeks, plus oxymetazoline 0.025%, 4 drops twice daily for two weeks

Experimental: Oral steroid
1mg/kg oral prednisolone for 10 days
Drug: Steroid Drug
Oral prednisolone, 1mg/kg body weight daily for 10 days




Primary Outcome Measures :
  1. Non B type tympanogram [ Time Frame: one month ]

Secondary Outcome Measures :
  1. cost of treatment [ Time Frame: one month ]
  2. Adverse effects [ Time Frame: one month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of mild ear ache or decreased hearing for three or more months, plus
  • intact and immobile tympanic membrane by pneumatic otoscopy
  • Type B tympanogram

Exclusion Criteria:

  • any external ear condition that hampers visualization of tympanic membrane
  • lost to follow up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590912


Locations
Layout table for location information
Nepal
Lumbini Medical College
Tansen, Palpa, Nepal, 32500
Sponsors and Collaborators
Lumbini Medical College

Layout table for additonal information
Responsible Party: Lumbini Medical College
ClinicalTrials.gov Identifier: NCT03590912     History of Changes
Other Study ID Numbers: 143
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: As soon as the article is published online. Life-long

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Nasal Decongestants
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Fluticasone
Oxymetazoline
Phenylephrine
Histamine
Histamine Antagonists
Histamine H1 Antagonists
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Vasoconstrictor Agents