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NCT Number: NCT00552981

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

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhalation of warm air in a Finnish sauna

Procedure

three times on three following days, each 2-3 minutes

inhalation of ambient air in a Finnish sauna

Procedure

three times on three following days, each 2-3 minutes

Primary outcomes

  1. Symptom Score for Common Cold

    Time frame: Area under the curve day 2 to 7

Secondary outcomes

  1. Usage of medication against common cold

    Time frame: Day 1 to 7

  2. generalized feeling ill on a numeric rating scale 0-10,

    Time frame: Day 1, 2, 3, 5 and 7

  3. safety (adverse events and serious adverse events)

    Time frame: 1 to 7 days

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Karl and Veronica Carstens Foundation

Registry information

Acronym: HELI

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 2, 2007
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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