Mucociliary ClearancePhase 4NCT00325767
Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
A Phase 4 study testing nebulized albuterol (2.5 mg/3ml/dose) and nebulized levalbuterol (1.25 mg/3ml/dose) in people with Mucociliary Clearance, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be significantly enhanced in healthy subjects by one week of inhalation of nebulized levalbuterol aerosol, as compared to racemic albuterol or placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucociliary Clearance
- What is being tested?
- nebulized albuterol (2.5 mg/3ml/dose) and nebulized levalbuterol (1.25 mg/3ml/dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Sep 2005
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-smoking males and non-pregnant females greater than or equal to 18 years of age
- forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted values
- normal systolic and diastolic blood pressures
Who cannot join
- history of heart disease, irregular heartbeat, hypertension
- history of diabetes, hyperthyroid
- history of pneumonia, tuberculosis
- history of seizure disorder, depression, hospitalization in the last month for non-elective purposes, cold or flu in the previous three months
Trial locations and contacts
1 site in 1 country.
United States1 site
Eudowood Division of Pediatric Respiratory Sciences
Baltimore, Maryland, 21287
About this study
The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be significantly enhanced in healthy subjects by one week of inhalation of nebulized levalbuterol aerosol, as compared to racemic albuterol or placebo. Subjects will inhale one week of levalbuterol, one week of racemic albuterol, and one week of placebo, in a randomized order.
Read the detailed description
In healthy lungs, inhaled insoluble material such as bacteria, viruses, antigens, and toxins deposit in the tracheobronchial airway mucus and are removed from the lung in a matter of hours by mucociliary clearance (MCC). When MCC is overwhelmed or impaired, some mucus can be removed by mechanical or cough clearance (CC). Impairment of MCC typically leads to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization, and chronic inflammation.
Racemic albuterol has been shown to stimulate MCC in various patient populations. Inhaled and subcutaneous terbutaline has also been shown to stimulate MCC in healthy subjects. We hypothesize that levalbuterol will be more potent than racemic albuterol in enhancing MCC and CC in healthy subjects.
- Conditions
- Mucociliary Clearance
- Being tested
- nebulized albuterol (2.5 mg/3ml/dose), nebulized levalbuterol (1.25 mg/3ml/dose), nebulized placebo (3ml/dose)
- Keywords
- mucociliary clearance, beta-adrenergic drugs, inhalation, aerosol
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized albuterol (2.5 mg/3ml/dose)Drug
nebulized levalbuterol (1.25 mg/3ml/dose)Drug
nebulized placebo (3ml/dose)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung mucociliary clearance
Lung cough clearance
Secondary outcomes (2)
Forced expiratory volume in 1 second
Forced vital capacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startMay 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucociliary ClearanceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Investigators
- Beth L Laube, Ph.D., Study director, Johns Hopkins UniversityJeffrey C Cleary, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325767
- Sponsor's protocol ID
- RPN 04-03-19-11
- Status last verified
- Apr 2006
- First submitted
- 12 May 2006
- Last updated
- 15 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
- ClinicalTrials.gov ID
- NCT00325767
- Acronym / sponsor ID
- RPN 04-03-19-11
- Conditions
- Mucociliary Clearance
- Keywords
- mucociliary clearance, beta-adrenergic drugs, inhalation, aerosol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- May 2004
- Study completion
- Sep 2005
- First posted
- 15 May 2006 (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.
The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be significantly enhanced in healthy subjects by one week of inhalation of nebulized levalbuterol aerosol, as compared to racemic albuterol or placebo. Subjects will inhale one week of levalbuterol, one week of racemic albuterol, and one week of placebo, in a randomized order.
Detailed description
In healthy lungs, inhaled insoluble material such as bacteria, viruses, antigens, and toxins deposit in the tracheobronchial airway mucus and are removed from the lung in a matter of hours by mucociliary clearance (MCC). When MCC is overwhelmed or impaired, some mucus can be removed by mechanical or cough clearance (CC). Impairment of MCC typically leads to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization, and chronic inflammation.
Racemic albuterol has been shown to stimulate MCC in various patient populations. Inhaled and subcutaneous terbutaline has also been shown to stimulate MCC in healthy subjects. We hypothesize that levalbuterol will be more potent than racemic albuterol in enhancing MCC and CC in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-smoking males and non-pregnant females greater than or equal to 18 years of age
- forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted values
- normal systolic and diastolic blood pressures
Key exclusion criteria (4 listed)
- history of heart disease, irregular heartbeat, hypertension
- history of diabetes, hyperthyroid
- history of pneumonia, tuberculosis
- history of seizure disorder, depression, hospitalization in the last month for non-elective purposes, cold or flu in the previous three months
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 |
|---|---|---|
| nebulized albuterol (2.5 mg/3ml/dose) | Drug | – |
| nebulized levalbuterol (1.25 mg/3ml/dose) | Drug | – |
| nebulized placebo (3ml/dose) | Drug | – |
Primary outcome
Lung mucociliary clearance
Lung cough clearance
2 secondary outcomes
Forced expiratory volume in 1 second
Forced vital capacity
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 15 May 2006.
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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.
Beth L Laube, Ph.D. study director
Johns Hopkins University
Jeffrey C Cleary, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nebulized albuterol (2.5 mg/3ml/dose) and nebulized levalbuterol (1.25 mg/3ml/dose) in people with Mucociliary Clearance, run by Johns Hopkins University at 1 site in United States.
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 3 inclusion and 4 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 15 May 2006. 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 United States. 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 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?
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?
Lung mucociliary clearance. The study lists 2 primary outcomes in all. 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 15 May 2006.