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

Common Cold Clinical Trial

— HELI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552981
• Other study ID #: HELI-2007
• Status: Completed
• Phase: N/A
• First received: November 1, 2007
• Last updated: July 9, 2012
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold

Intervention

Procedure:
• inhalation of warm air in a Finnish sauna
three times on three following days, each 2-3 minutes
• inhalation of ambient air in a Finnish sauna
three times on three following days, each 2-3 minutes

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pach D, Knöchel B, Lüdtke 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Score for Common Cold		Area under the curve day 2 to 7	No
Secondary	Usage of medication against common cold		Day 1 to 7	No
Secondary	generalized feeling ill on a numeric rating scale 0-10,		Day 1, 2, 3, 5 and 7	Yes
Secondary	safety (adverse events and serious adverse events)		1 to 7 days	Yes