Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)
HELI
1 other identifier
interventional
157
1 country
1
Brief Summary
In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions:
- 1.the inhalation of warm air for inducing a warming of the throat and
- 2.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedFirst Posted
Study publicly available on registry
November 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJuly 10, 2012
July 1, 2012
1.4 years
November 1, 2007
July 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom Score for Common Cold
Area under the curve day 2 to 7
Secondary Outcomes (3)
Usage of medication against common cold
Day 1 to 7
generalized feeling ill on a numeric rating scale 0-10,
Day 1, 2, 3, 5 and 7
safety (adverse events and serious adverse events)
1 to 7 days
Study Arms (2)
1
ACTIVE COMPARATOR2
SHAM COMPARATORInterventions
three times on three following days, each 2-3 minutes
three times on three following days, each 2-3 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- fever \>38.5°C
- systolic blood pressure below 100 mmHg or above 160 mmHg
- severe chronic disease, which makes study participation impossible
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, 10117, Germany
Related Publications (1)
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.
PMID: 21143077RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia M. Witt, MD
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
November 1, 2007
First Posted
November 2, 2007
Study Start
November 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
July 10, 2012
Record last verified: 2012-07