Airway InflammationPhase 1NCT00869596
Study of Biomarkers of Airway Inflammation (0000-128)
A Phase 1 study testing fluticasone propionate, Comparator: Lipopolysaccharide (LPS) and Comparator: albuterol in people with Airway Inflammation, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Inflammation
- What is being tested?
- fluticasone propionate, Comparator: Lipopolysaccharide (LPS) and Comparator: albuterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Sep 2009
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
- Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
- Subject is a nonsmoker
- Subject is in generally good health
- Subject is willing to comply with the diet, alcohol, and caffeine study restrictions
Who cannot join
- Subject is a nursing mother
- Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
- Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
- Subject has a recent history of allergic rhinitis at screening
- Subject has any respiratory disease at screening
- Subject has daily phlegm or a chronic cough
Show all 12Show fewer
- Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening
- Subject has a history of stroke, seizures, or major neurological disorders
- Subject regularly uses illicit drugs or has a history of drug/alcohol abuse
- Subject received a vaccination within 3 weeks of screening
About this study
Official title: A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects
This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.
- Conditions
- Airway Inflammation
- Being tested
- fluticasone propionate, Comparator: Placebo to fluticasone, Comparator: Lipopolysaccharide (LPS), Comparator: albuterol
- Keywords
- Sputum inflammatory biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone propionateDrug
Single dose of fluticasone 440 mcg (2 x 220 mcg) or 1980 mcg (9 x 220 mcg) by metered dose inhaler in two of three treatment periods
Comparator: Placebo to fluticasoneDrug
Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
Comparator: Lipopolysaccharide (LPS)Drug
20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
Comparator: albuterolDrug
Albuterol two 100 mcg inhalations by metered dose inhaler prior to sputum induction at screening, twice during each of the three treatment periods, and at the post-study follow up visit.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo to fluticasone; Drug: Comparator: Lipopolysaccharide (LPS); Drug: Comparator: albuterol |
| 2 | Active comparator | Fluticasone 440 mcg Receives: Drug: fluticasone propionate; Drug: Comparator: Lipopolysaccharide (LPS); Drug: Comparator: albuterol |
| 3 | Active comparator | Fluticasone 1980 mcg Receives: Drug: fluticasone propionate; Drug: Comparator: Lipopolysaccharide (LPS); Drug: Comparator: albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum percent neutrophils
Measured: 6 hours following inhaled LPS challenge
Secondary outcomes (3)
Sputum absolute neutrophils (per mL)
Measured: 6 hours following inhaled LPS challenge
Sputum levels of IL1beta and IL8
Measured: 6 hours following inhaled LPS challenge
Sputum mRNA expression levels of CD14 and IL1beta
Measured: 6 hours following inhaled LPS challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway InflammationStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869596
- Sponsor's protocol ID
- 0000-128
- Other IDs
- 2009_565
- Status last verified
- Jul 2015
- First submitted
- 25 Mar 2009
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00869596
- Acronym / sponsor ID
- 0000-128
- Conditions
- Airway Inflammation
- Keywords
- Sputum inflammatory biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Mar 2009 (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 study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Comparator: Placebo to fluticasone, Drug: Comparator: Lipopolysaccharide (LPS), Drug: Comparator: albuterolPlacebo |
| 2 | Active comparator | Drug: fluticasone propionate, Drug: Comparator: Lipopolysaccharide (LPS), Drug: Comparator: albuterolFluticasone 440 mcg |
| 3 | Active comparator | Drug: fluticasone propionate, Drug: Comparator: Lipopolysaccharide (LPS), Drug: Comparator: albuterolFluticasone 1980 mcg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
- Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
- Subject is a nonsmoker
- Subject is in generally good health
- Subject is willing to comply with the diet, alcohol, and caffeine study restrictions
Key exclusion criteria (12 listed)
- Subject is a nursing mother
- Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
- Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
- Subject has a recent history of allergic rhinitis at screening
- Subject has any respiratory disease at screening
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 |
|---|---|---|
| fluticasone propionateSingle dose of fluticasone 440 mcg (2 x 220 mcg) or 1980 mcg (9 x 220 mcg) by metered dose inhaler in two of three treatment periods | Drug | 2, 3 |
| Comparator: Placebo to fluticasoneSingle dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods | Drug | 1 |
| Comparator: Lipopolysaccharide (LPS)20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods | Drug | 1, 2, 3 |
| Comparator: albuterolAlbuterol two 100 mcg inhalations by metered dose inhaler prior to sputum induction at screening, twice during each of the three treatment periods, and at the post-study follow up visit. | Drug | 1, 2, 3 |
Primary outcome
Sputum percent neutrophils
Time frame: 6 hours following inhaled LPS challenge
3 secondary outcomes
Sputum absolute neutrophils (per mL)
Time frame: 6 hours following inhaled LPS challenge
Sputum levels of IL1beta and IL8
Time frame: 6 hours following inhaled LPS challenge
Sputum mRNA expression levels of CD14 and IL1beta
Time frame: 6 hours following inhaled LPS challenge
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 23 Jul 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fluticasone propionate, Comparator: Lipopolysaccharide (LPS) and Comparator: albuterol in people with Airway Inflammation, run by Merck Sharp & Dohme LLC.
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 12 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 23 Jul 2015. 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. Some participants in this study may receive a placebo. 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 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.
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?
Sputum percent neutrophils (time frame: 6 hours following inhaled LPS challenge). 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 23 Jul 2015.