AsthmaPhase 1/2NCT00801307
Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease
A Phase 1/2 study testing spirometer in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Air Liquide SA at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease, Healthy
- What is being tested?
- spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Mar 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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),
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- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Inamed Research GmbH & Co. KG
Robert-Koch-Allee 2, Gauting, 82131
About this study
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
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.
Read the 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.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, Healthy
- Being tested
- spirometer
- Keywords
- evaluate Inspiratory Capacity (IC) measured by spirometry
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometerDevice
Also called ergospirometer
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | He/O2 78:22 Receives: Device: spirometer |
| 2 | Experimental | He/O2 65:35 Receives: Device: spirometer |
| 3 | Active comparator | Medical Air Receives: Device: spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Capacity measured by spirometry at rest while breathing each He/O2 mixture compared to its measurement on medical air
Measured: 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,
Measured: 20 Mn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inamed
- Responsible party
- Sponsor
- Investigators
- Thomas Meyer, Dr. med., Principal investigator, Inamed Research GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801307
- Sponsor's protocol ID
- ALMED-07-C2-012
- Other IDs
- 2007-004158-10
- Status last verified
- Aug 2014
- First submitted
- 2 Dec 2008
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00801307
- Acronym / sponsor ID
- ALMED-07-C2-012
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, Healthy
- Keywords
- evaluate Inspiratory Capacity (IC) measured by spirometry
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Air Liquide SAIndustry (pharma, biotech, devices)
- Collaborators
- Inamed
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: spirometerHe/O2 78:22 |
| 2 | Experimental | Device: spirometerHe/O2 65:35 |
| 3 | Active comparator | Device: spirometerMedical Air |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All subjects/patients:
- Healthy volunteers:
- Patients with moderate/severe persistent asthma:
- Aged ≥ 45 and £ 80 years old,
- Documented clinical diagnosis of moderate or severe COPD(according to GOLD 2006 guidelines),
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometerAlso: ergospirometerAccording 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. | Device | 1, 2, 3 |
Primary outcome
Inspiratory Capacity measured by spirometry at rest while breathing each He/O2 mixture compared to its measurement on medical air
Time frame: 30 mn
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Meyer, Dr. med. principal investigator
Inamed Research GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing spirometer in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Air Liquide SA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory Capacity measured by spirometry at rest while breathing each He/O2 mixture compared to its measurement on medical air (time frame: 30 mn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.