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Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough

Primary Purpose

Respiratory Tract Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ointment containing camphor, eucalyptus oil, and menthol
Petroleum jelly
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Diseases focused on measuring Cough symptoms, Cold symptoms, Congestion, Children, URI, Alternative cough symptom treatment

Eligibility Criteria

2 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cough and congestion attributed to upper respiratory tract infection

Exclusion Criteria:

  • Children with signs or symptoms of more serious or treatable disease
  • Presence of itchy, watery eyes or frequent sneezing
  • Tachypnea (respiratory rate >95%ile) or labored breathing
  • Symptoms for 8 or more days
  • History of asthma in the past 2 years, chronic lung disease, or seizure disorder
  • History of an allergic reaction to camphor, menthol, eucalyptus, petrolatum, cedarleaf oil, nutmeg oil, thymol, turpentine oil, Over-the-counter medication containing VVR components

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

A

B

3

Arm Description

no intervention

Outcomes

Primary Outcome Measures

Subjective assessment of cough and congestion symptoms

Secondary Outcome Measures

Full Information

First Posted
August 28, 2008
Last Updated
November 21, 2017
Sponsor
Penn State University
Collaborators
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00743990
Brief Title
Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough
Official Title
Effect of a Medicated Topical Therapy, Petrolatum, and No Treatment on Nocturnal Cough and Congestion for Children With Upper Respiratory Infections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
Procter and Gamble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub® (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as rated by both parents and children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Diseases
Keywords
Cough symptoms, Cold symptoms, Congestion, Children, URI, Alternative cough symptom treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
Ointment containing camphor, eucalyptus oil, and menthol
Intervention Description
One time use
Intervention Type
Other
Intervention Name(s)
Petroleum jelly
Intervention Description
One time use
Primary Outcome Measure Information:
Title
Subjective assessment of cough and congestion symptoms
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cough and congestion attributed to upper respiratory tract infection Exclusion Criteria: Children with signs or symptoms of more serious or treatable disease Presence of itchy, watery eyes or frequent sneezing Tachypnea (respiratory rate >95%ile) or labored breathing Symptoms for 8 or more days History of asthma in the past 2 years, chronic lung disease, or seizure disorder History of an allergic reaction to camphor, menthol, eucalyptus, petrolatum, cedarleaf oil, nutmeg oil, thymol, turpentine oil, Over-the-counter medication containing VVR components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian M Paul, MD, MSc
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21059712
Citation
Paul IM, Beiler JS, King TS, Clapp ER, Vallati J, Berlin CM Jr. Vapor rub, petrolatum, and no treatment for children with nocturnal cough and cold symptoms. Pediatrics. 2010 Dec;126(6):1092-9. doi: 10.1542/peds.2010-1601. Epub 2010 Nov 8.
Results Reference
derived

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Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough

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