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Clinical Trials/NCT00552981
NCT00552981CompletedNot Applicable

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

Charite University, Berlin, Germany1 site in 1 country157 target enrollmentStarted: November 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
157
Locations
1
Primary Endpoint
Symptom Score for Common Cold
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Active Comparator

Intervention: inhalation of warm air in a Finnish sauna (Procedure)

2

Sham Comparator

Intervention: inhalation of ambient air in a Finnish sauna (Procedure)

Outcomes

Primary Outcomes

Symptom Score for Common Cold

Time Frame: Area under the curve day 2 to 7

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudia M. Witt

Prof. Dr. med.

Charite University, Berlin, Germany

Study Sites (1)

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