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

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease, Healthy

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
spirometer
Sponsored by
Air Liquide SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma focused on measuring evaluate Inspiratory Capacity (IC) measured by spirometry

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All subjects/patients:

    • Willing and able to complete the requirements of this study including the signature of the written informed consent,
    • Able to complete the study in 5 working days or less,
    • Able to perform pulmonary function tests

  • Healthy volunteers:

    • Never smoker or subject who stopped smoking at least 6 months before selection (strictly less than 10 pack-years),
    • Having pulmonary function tests within the normal range(according to predicted values for age, sex and height as referenced in ATS/ERS 1993 standards)

  • Patients with moderate/severe persistent asthma:

    • Documented clinical diagnosis of moderate or severe persistent asthma (according to GINA 2006 guidelines),
    • Stable asthma in the 4 weeks prior to selection as evidenced by no change in asthma medication, no treatment for asthma in an emergency,acute care setting and no admission to hospital for acute asthma

Patients with moderate / severe COPD:

  • Aged ≥ 45 and £ 80 years old,
  • Documented clinical diagnosis of moderate or severe COPD(according to GOLD 2006 guidelines),
  • With a smoking history of 10 pack-years or more,
  • Stable COPD in the 4 weeks prior to selection as evidenced by no change in COPD medication, no treatment for COPD in an emergency, acute care setting and no admission to hospital for COPD exacerbation

Exclusion Criteria:

  • Obese subject/patient having a Body Mass Index (BMI) > 35,
  • Past or present respiratory disease including being free from the common cold and rhinitis for at least 4 weeks before selection except asthma for asthmatic patients and COPD for COPD patients,
  • Daily need for 12 hours or more of long term oxygen therapy,
  • Pregnant or lactating woman,
  • Lack of efficient contraception according to CPMP/ICH 286/95 note 31,
  • Any contra-indication to perform pulmonary function tests or light cycling exercise,
  • Clinically significant or uncontrolled pathologic conditions which may interfere with the study procedures,
  • Drug abuse or psychic disorders resulting in an inability to fully understand the requirements of the study,
  • Legal status which prohibits informed consent,
  • Participation in any interventional clinical trial within 30 days prior to selection

Sites / Locations

  • Inamed Research GmbH & Co. KG

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

He/O2 78:22

He/O2 65:35

Medical Air

Outcomes

Primary Outcome Measures

Inspiratory Capacity measured by spirometry at rest while breathing each He/O2 mixture compared to its measurement on medical air

Secondary Outcome Measures

Inspiratory Capacity measured by ergospirometry while breathing Pulmonary function parameters at rest, i.e., FEV1, FVC, FEF25-75, PEF and ERV while breathing each He/O2 mixture compared to medical air,

Full Information

First Posted
December 2, 2008
Last Updated
August 8, 2014
Sponsor
Air Liquide SA
Collaborators
Inamed
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1. Study Identification

Unique Protocol Identification Number
NCT00801307
Brief Title
Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease
Official Title
A Single Site,Exploratory,Phase I/II,Randomised Trial Comparing the Effect of He/O2 Mixtures(He/O2 78:22 and He/O2 65:35) to Medical Air on Pulmonary Function in Moderate/Severe Asthma and COPD Patients and Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide SA
Collaborators
Inamed

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Two types of measurements will be performed with each of the three evaluated gases: pulmonary function measurements at rest to establish the resistance to airflow in a reproducible way, including the measurements of Inspiratory Capacity (IC), Forced Expiratory Volume in 1 second (FEV1), Forced Expiratory Flows (FEF) at different lung volumes (25 to 75% of the vital capacity), and Forced Vital Capacity (FVC), Tidal Volume (TV) measured at rest and during light cycling exercise. The results of this study should be useful to evaluate the extent of influence on gas concentration, since none of the previous trials have been performed with He/O2 65:35, as well as the extent of influence on the lung disease, since none of the previous trials have been performed with asthmatic patients at various disease stages. The working hypothesis is that when using He/O2 mixtures 78:22 and 65:35, the flow resistance decreases as compared to medical air because low density helium replaces nitrogen, thus resulting in a lower workload of breathing for asthmatic and COPD patients. For patients with reduced pulmonary function, this difference might result in greater Inspiratory Capacity. That is why Inspiratory Capacity will be measured as primary efficacy criterion, but also Tidal Volume and other pulmonary function parameters on 3 types of subjects/patients : healthy volunteers, patients with moderate and severe persistent asthma, patients with moderate and severe COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease, Healthy
Keywords
evaluate Inspiratory Capacity (IC) measured by spirometry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
He/O2 78:22
Arm Title
2
Arm Type
Experimental
Arm Description
He/O2 65:35
Arm Title
3
Arm Type
Active Comparator
Arm Description
Medical Air
Intervention Type
Device
Intervention Name(s)
spirometer
Other Intervention Name(s)
ergospirometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inspiratory Capacity measured by spirometry at rest while breathing each He/O2 mixture compared to its measurement on medical air
Time Frame
30 mn
Secondary Outcome Measure Information:
Title
Inspiratory Capacity measured by ergospirometry while breathing Pulmonary function parameters at rest, i.e., FEV1, FVC, FEF25-75, PEF and ERV while breathing each He/O2 mixture compared to medical air,
Time Frame
20 Mn

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All subjects/patients: Willing and able to complete the requirements of this study including the signature of the written informed consent, Able to complete the study in 5 working days or less, Able to perform pulmonary function tests Healthy volunteers: Never smoker or subject who stopped smoking at least 6 months before selection (strictly less than 10 pack-years), Having pulmonary function tests within the normal range(according to predicted values for age, sex and height as referenced in ATS/ERS 1993 standards) Patients with moderate/severe persistent asthma: Documented clinical diagnosis of moderate or severe persistent asthma (according to GINA 2006 guidelines), Stable asthma in the 4 weeks prior to selection as evidenced by no change in asthma medication, no treatment for asthma in an emergency,acute care setting and no admission to hospital for acute asthma Patients with moderate / severe COPD: Aged ≥ 45 and £ 80 years old, Documented clinical diagnosis of moderate or severe COPD(according to GOLD 2006 guidelines), With a smoking history of 10 pack-years or more, Stable COPD in the 4 weeks prior to selection as evidenced by no change in COPD medication, no treatment for COPD in an emergency, acute care setting and no admission to hospital for COPD exacerbation Exclusion Criteria: Obese subject/patient having a Body Mass Index (BMI) > 35, Past or present respiratory disease including being free from the common cold and rhinitis for at least 4 weeks before selection except asthma for asthmatic patients and COPD for COPD patients, Daily need for 12 hours or more of long term oxygen therapy, Pregnant or lactating woman, Lack of efficient contraception according to CPMP/ICH 286/95 note 31, Any contra-indication to perform pulmonary function tests or light cycling exercise, Clinically significant or uncontrolled pathologic conditions which may interfere with the study procedures, Drug abuse or psychic disorders resulting in an inability to fully understand the requirements of the study, Legal status which prohibits informed consent, Participation in any interventional clinical trial within 30 days prior to selection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Meyer, Dr. med.
Organizational Affiliation
Inamed Research GmbH & Co. KG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inamed Research GmbH & Co. KG
City
Robert-Koch-Allee 2
State/Province
Gauting
ZIP/Postal Code
82131
Country
Germany

12. IPD Sharing Statement

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

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