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

July 9, 2012 updated by: Claudia M. Witt, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom Score for Common Cold
Time Frame: Area under the curve day 2 to 7
Area under the curve day 2 to 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Usage of medication against common cold
Time Frame: Day 1 to 7
Day 1 to 7
generalized feeling ill on a numeric rating scale 0-10,
Time Frame: Day 1, 2, 3, 5 and 7
Day 1, 2, 3, 5 and 7
safety (adverse events and serious adverse events)
Time Frame: 1 to 7 days
1 to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Karl and Veronica Carstens Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (ESTIMATE)

November 2, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELI-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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