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Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease

NCT00801307 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-08-11

No results posted yet for this study

Summary

This clinical trial will include healthy volunteers, COPD patients and asthmatic patients who will breathe He/O2 78:22, He/O2 65:35 and medical air consecutively in a randomised order.

Conditions

Interventions

DEVICE

spirometer

According to the randomisation order, the appropriate medical gas cylinder with the pressure regulator will be connected to a humidifier to avoid the inhalation of very dry gas; the humidifier will be connected to the breathing bag; the flow of the medical gas will be adjusted individually for each subject/patient by the valve of the pressure regulator.

Sponsors & Collaborators

  • Inamed

    collaborator INDUSTRY

  • Air Liquide SA

    lead INDUSTRY

Principal Investigators

  • Thomas Meyer, Dr. med. · Inamed Research GmbH & Co. KG

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-03-31
Completion
2010-03-31

Countries

  • Germany

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00801307 on ClinicalTrials.gov