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

NCT00801307 | Completed Phase 1 DMC

• 2 other identifiers: ALMED-07-C2-0122007-004158-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease; Healthy

Keywords

evaluate Inspiratory Capacity (IC) measured by spirometry

Outcome Measures

Primary Outcomes (1)

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

  30 mn

Secondary Outcomes (1)

• 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,

  20 Mn

Study Arms (3)

1

EXPERIMENTAL

He/O2 78:22

Device: spirometer

2

EXPERIMENTAL

He/O2 65:35

Device: spirometer

3

ACTIVE COMPARATOR

Medical Air

Device: spirometer

Interventions

spirometer DEVICE

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.

Also known as: ergospirometer

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide SA: lead
• Inamed: collaborator

Study Sites (1)

Inamed Research GmbH & Co. KG

Robert-Koch-Allee 2, Gauting, 82131, Germany

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Meyer, Dr. med.

  Inamed Research GmbH & Co. KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

DE (1)