Effectiveness of Local Application of Warm Air in Patient... | NCT00552981

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

NCT00552981

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

157Actual

Phase

Not Applicable

Conditions

Common Cold

Interventions

inhalation of warm air in a Finnish sauna
inhalation of ambient air in a Finnish sauna

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Nov 1, 2007

First Submission Date that Met QC Criteria

Nov 1, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
Karl and Veronica Carstens Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions:

the inhalation of warm air for inducing a warming of the throat and
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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Procedure: inhalation of warm air in a Finnish sauna
2	Sham Comparator		Procedure: inhalation of ambient air in a Finnish sauna

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inhalation of warm air in a Finnish sauna	Procedure	three times on three following days, each 2-3 minutes	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia M. Witt, MD	Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center		Berlin		10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21143077	Result	Pach D, Knochel B, Ludtke 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. doi: 10.5694/j.1326-5377.2010.tb04127.x.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections