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Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study) (HELI)

Primary Purpose

Common Cold

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
inhalation of warm air in a Finnish sauna
inhalation of ambient air in a Finnish sauna
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold focused on measuring common cold, Finnish sauna, rct

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptom duration between 2 and 24 hours
  • at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever
  • no usage of medication bought in a pharmacy
  • informed consent

Exclusion Criteria:

  • fever >38.5°C
  • systolic blood pressure below 100 mmHg or above 160 mmHg
  • severe chronic disease, which makes study participation impossible
  • pregnancy

Sites / Locations

  • Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Symptom Score for Common Cold

Secondary Outcome Measures

Usage of medication against common cold
generalized feeling ill on a numeric rating scale 0-10,
safety (adverse events and serious adverse events)

Full Information

First Posted
November 1, 2007
Last Updated
July 9, 2012
Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00552981
Brief Title
Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)
Acronym
HELI
Official Title
Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions: the inhalation of warm air for inducing a warming of the throat and the inhalation of ambient air as control. As outcome the effect on symptoms and duration of the common cold will be assessed. The interventions will consist of visits with a duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be fully dressed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
common cold, Finnish sauna, rct

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
inhalation of warm air in a Finnish sauna
Intervention Description
three times on three following days, each 2-3 minutes
Intervention Type
Procedure
Intervention Name(s)
inhalation of ambient air in a Finnish sauna
Intervention Description
three times on three following days, each 2-3 minutes
Primary Outcome Measure Information:
Title
Symptom Score for Common Cold
Time Frame
Area under the curve day 2 to 7
Secondary Outcome Measure Information:
Title
Usage of medication against common cold
Time Frame
Day 1 to 7
Title
generalized feeling ill on a numeric rating scale 0-10,
Time Frame
Day 1, 2, 3, 5 and 7
Title
safety (adverse events and serious adverse events)
Time Frame
1 to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptom duration between 2 and 24 hours at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever no usage of medication bought in a pharmacy informed consent Exclusion Criteria: fever >38.5°C systolic blood pressure below 100 mmHg or above 160 mmHg severe chronic disease, which makes study participation impossible pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M. Witt, MD
Organizational Affiliation
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21143077
Citation
Pach D, Knochel B, Ludtke R, Wruck K, Willich SN, Witt CM. Visiting a sauna: does inhaling hot dry air reduce common cold symptoms? A randomised controlled trial. Med J Aust. 2010 Dec 6-20;193(11-12):730-4. doi: 10.5694/j.1326-5377.2010.tb04127.x.
Results Reference
result

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Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)

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