AsthmaPhase 4NCT02170532
Aerosolized Beta-Agonist Isomers in Asthma
A Phase 4 study testing levalbuterol, saline and levalbuterol MDI in people with Asthma, run by Duke University.
Trial summary
Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- levalbuterol, saline and levalbuterol MDI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program
- greater than 18 years of age
- requiring bronchodilator therapy either routinely or on a as needed (PRN)basis
- stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease
- patients may or may not be on inhaled corticosteroids
Who cannot join
- no unstable cardiovascular symptoms
- no unstable angina
- must be at least four weeks removed from an acute coronary syndrome
About this study
Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.
Read the detailed description
Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.
- Conditions
- Asthma
- Being tested
- levalbuterol, saline, levalbuterol MDI, breath actuated nebulizer, aerochamber max
- Keywords
- asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levalbuterolDrug
0.5 ml. levalbuterol
salineDrug
0.5ml saline
levalbuterol MDIOther
breath actuated nebulizerDevice
aerochamber maxDevice
ipratropriumDrug
| Study group | Role | What they receive |
|---|---|---|
| levalbuterol + saline in a breath actuated nebulizer | Active comparator | 0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer Receives: Drug: levalbuterol; Drug: saline; Device: breath actuated nebulizer |
| levalbuterol + ipratroprium in a breath actuated nebulizer | Active comparator | 0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer Receives: Drug: levalbuterol; Device: breath actuated nebulizer; Drug: ipratroprium |
| levalbuterol MDI 2 puffs | Active comparator | levalbuterol metered dose inhaler 2 puffs Receives: Other: levalbuterol MDI |
| levalbuterol MDI + aerochamber max without pause 2 puffs | Active comparator | levalbuterol MDI + aerochamber max without pause 2 puffs Receives: Other: levalbuterol MDI; Device: aerochamber max |
| levalbuterol MDI + aerochamber max with 2 second pause 2 puffs | Active comparator | levalbuterol MDI + aerochamber max with 2 second pause 2 puffs Receives: Other: levalbuterol MDI; Device: aerochamber max |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Forced Expiratory Volume at One Second (FEV1)
Measured: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Secondary outcomes (4)
Change in 8 Hour Area-under-the-curve FEV1
Measured: 0 to 8 hours post dose
Change in Heart Rate
Measured: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Change in Tremor Assessment Measured by a Scale
Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).
Measured: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale
Measured: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil MacIntyre, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170532
- Sponsor's protocol ID
- Pro00013822
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 13 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosolized Beta-Agonist Isomers in Asthma
- ClinicalTrials.gov ID
- NCT02170532
- Acronym / sponsor ID
- Pro00013822
- Conditions
- Asthma
- Keywords
- asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 4 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.
Detailed description
Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| levalbuterol + saline in a breath actuated nebulizer | Active comparator | Drug: levalbuterol, Drug: saline, Device: breath actuated nebulizer0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer |
| levalbuterol + ipratroprium in a breath actuated nebulizer | Active comparator | Drug: levalbuterol, Device: breath actuated nebulizer, Drug: ipratroprium0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer |
| levalbuterol MDI 2 puffs | Active comparator | Other: levalbuterol MDIlevalbuterol metered dose inhaler 2 puffs |
| levalbuterol MDI + aerochamber max without pause 2 puffs | Active comparator | Other: levalbuterol MDI, Device: aerochamber maxlevalbuterol MDI + aerochamber max without pause 2 puffs |
| levalbuterol MDI + aerochamber max with 2 second pause 2 puffs | Active comparator | Other: levalbuterol MDI, Device: aerochamber maxlevalbuterol MDI + aerochamber max with 2 second pause 2 puffs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program
- greater than 18 years of age
- requiring bronchodilator therapy either routinely or on a as needed (PRN)basis
- stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease
- patients may or may not be on inhaled corticosteroids
Key exclusion criteria (3 listed)
- no unstable cardiovascular symptoms
- no unstable angina
- must be at least four weeks removed from an acute coronary syndrome
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 |
|---|---|---|
| levalbuterol0.5 ml. levalbuterol | Drug | levalbuterol + ipratroprium in a breath actuated nebulizer, levalbuterol + saline in a breath actuated nebulizer |
| saline0.5ml saline | Drug | levalbuterol + saline in a breath actuated nebulizer |
| levalbuterol MDI | Other | levalbuterol MDI + aerochamber max with 2 second pause 2 puffs, levalbuterol MDI + aerochamber max without pause 2 puffs, levalbuterol MDI 2 puffs |
| breath actuated nebulizer | Device | levalbuterol + ipratroprium in a breath actuated nebulizer, levalbuterol + saline in a breath actuated nebulizer |
| aerochamber max | Device | levalbuterol MDI + aerochamber max with 2 second pause 2 puffs, levalbuterol MDI + aerochamber max without pause 2 puffs |
| ipratroprium | Drug | levalbuterol + ipratroprium in a breath actuated nebulizer |
Primary outcome
Change in Maximum Forced Expiratory Volume at One Second (FEV1)
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
4 secondary outcomes
Change in 8 Hour Area-under-the-curve FEV1
Time frame: 0 to 8 hours post dose
Change in Heart Rate
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Change in Tremor Assessment Measured by a Scale
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale
Time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Neil MacIntyre, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levalbuterol, saline and levalbuterol MDI in people with Asthma, run by Duke University.
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 5 inclusion and 3 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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Maximum Forced Expiratory Volume at One Second (FEV1) (time frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment). 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 13 Aug 2014.