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

This study has been completed.
Sponsor:
Collaborator:
Karl and Veronica Carstens Foundation
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00552981
First received: November 1, 2007
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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.

Condition Intervention
Common Cold
Procedure: inhalation of warm air in a Finnish sauna
Procedure: inhalation of ambient air in a Finnish sauna

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Symptom Score for Common Cold [ Time Frame: Area under the curve day 2 to 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Usage of medication against common cold [ Time Frame: Day 1 to 7 ] [ Designated as safety issue: No ]
  • generalized feeling ill on a numeric rating scale 0-10, [ Time Frame: Day 1, 2, 3, 5 and 7 ] [ Designated as safety issue: Yes ]
  • safety (adverse events and serious adverse events) [ Time Frame: 1 to 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 157
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: inhalation of warm air in a Finnish sauna
three times on three following days, each 2-3 minutes
Sham Comparator: 2 Procedure: inhalation of ambient air in a Finnish sauna
three times on three following days, each 2-3 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552981

Locations
Germany
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Karl and Veronica Carstens Foundation
Investigators
Principal Investigator: Claudia M. Witt, MD Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
  More Information

Publications:
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00552981     History of Changes
Other Study ID Numbers: HELI-2007
Study First Received: November 1, 2007
Last Updated: July 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
common cold
Finnish sauna
rct

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014