Pulmonary Disease, Chronic ObstructivePhase 1NCT00551811
Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
A Phase 1 study testing SB-656933-AAA in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- SB-656933-AAA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 8 Oct 2007to 22 Jul 2008
- 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
- Healthy subjects between 18-50 years.
- Females should be of non-child bearing potential.
- Non-smoking for at least 12 months.
- Normal lung function.
- Subjects should be able to produce acceptable sputum samples.
Who cannot join
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
- Currently on regular medication except paracetamol.
- Body Mass Index <20 or >30.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Ranging Study to Assess the Effect of Pre-treatment With a Single Dose of Oral SB656933 on Lung Inflammation Following Challenge With Inhaled Ozone and Intermittent Exercise in Healthy Volunteers, Relative to Placebo
A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- SB-656933-AAA, Placebo
- Keywords
- SB-656933-AAA,, ozone challenge, single dose,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-656933-AAADrug
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.
PlaceboDrug
Placebo tablets will be intended to be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment sequence 1 | Experimental | Eligible subjects will receive single doses of placebo in period 1, SB-656933-AAA with a dose of 50 milligrams in period 2 and 150 milligrams in period 3. Receives: Drug: SB-656933-AAA; Drug: Placebo |
| Subjects receiving treatment sequence 2 | Experimental | Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, placebo in period 2 and SB-656933-AAA 150 milligrams in period 3. Receives: Drug: SB-656933-AAA; Drug: Placebo |
| Subjects receiving treatment sequence 3 | Experimental | Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, 150 milligrams in period 2 and placebo in period 3. Receives: Drug: SB-656933-AAA; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of a single dose of SB-656933-AAA on ozone-induced inflammation in healthy subjects. Total number of neutrophils in sputum 6 hours after inhaling ozone.
Measured: 6 hours after inhaling ozone
Secondary outcomes (1)
Total number of white cells in sputum 6 hours after inhaling ozone. Concentration of protein in sputum. Safety of SB-656933-AAA.
Measured: 6 hours after inhaling ozone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study start8 Oct 2007
- Primary completion22 Jul 2008
- Study completion22 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551811
- Sponsor's protocol ID
- CR2100597
- Status last verified
- Aug 2017
- First submitted
- 29 Oct 2007
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lazaar AL, Sweeney LE, MacDonald AJ, Alexis NE, Chen C, Tal-Singer R. SB-656933, a novel CXCR2 selective antagonist, inhibits ex vivo neutrophil activation and ozone-induced airway inflammation in humans. Br J Clin Pharmacol. 2011 Aug;72(2):282-93. doi: 10.1111/j.1365-2125.2011.03968.x.
PubMed 21426372
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Ranging Study to Assess the Effect of Pre-treatment With a Single Dose of Oral SB656933 on Lung Inflammation Following Challenge With Inhaled Ozone and Intermittent Exercise in Healthy Volunteers, Relative to Placebo
- ClinicalTrials.gov ID
- NCT00551811
- Acronym / sponsor ID
- CR2100597
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- SB-656933-AAA,, ozone challenge, single dose,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2007 (actual)
- Primary completion
- 22 Jul 2008 (actual)
- Study completion
- 22 Jul 2008 (actual)
- First posted
- 31 Oct 2007 (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.
A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment sequence 1 | Experimental | Drug: SB-656933-AAA, Drug: PlaceboEligible subjects will receive single doses of placebo in period 1, SB-656933-AAA with a dose of 50 milligrams in period 2 and 150 milligrams in period 3. |
| Subjects receiving treatment sequence 2 | Experimental | Drug: SB-656933-AAA, Drug: PlaceboEligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, placebo in period 2 and SB-656933-AAA 150 milligrams in period 3. |
| Subjects receiving treatment sequence 3 | Experimental | Drug: SB-656933-AAA, Drug: PlaceboEligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, 150 milligrams in period 2 and placebo in period 3. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects between 18-50 years.
- Females should be of non-child bearing potential.
- Non-smoking for at least 12 months.
- Normal lung function.
- Subjects should be able to produce acceptable sputum samples.
Key exclusion criteria (4 listed)
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
- Currently on regular medication except paracetamol.
- Body Mass Index <20 or >30.
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 |
|---|---|---|
| SB-656933-AAASB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally. | Drug | Subjects receiving treatment sequence 1, Subjects receiving treatment sequence 2, Subjects receiving treatment sequence 3 |
| PlaceboPlacebo tablets will be intended to be administered orally. | Drug | Subjects receiving treatment sequence 1, Subjects receiving treatment sequence 2, Subjects receiving treatment sequence 3 |
Primary outcome
To assess the effect of a single dose of SB-656933-AAA on ozone-induced inflammation in healthy subjects. Total number of neutrophils in sputum 6 hours after inhaling ozone.
Time frame: 6 hours after inhaling ozone
1 secondary outcome
Total number of white cells in sputum 6 hours after inhaling ozone. Concentration of protein in sputum. Safety of SB-656933-AAA.
Time frame: 6 hours after inhaling ozone
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 7 Aug 2017.
- Background: PubMed 21426372Lazaar AL, Sweeney LE, MacDonald AJ, Alexis NE, Chen C, Tal-Singer R. SB-656933, a novel CXCR2 selective antagonist, inhibits ex vivo neutrophil activation and ozone-induced airway inflammation in humans. Br J Clin Pharmacol. 2011 Aug;72(2):282-93. doi: 10.1111/j.1365-2125.2011.03968.x.
- Results for study CR2100597 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB-656933-AAA in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline 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 5 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 7 Aug 2017. 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 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?
To assess the effect of a single dose of SB-656933-AAA on ozone-induced inflammation in healthy subjects. Total number of neutrophils in sputum 6 hours after inhaling ozone. (time frame: 6 hours after inhaling ozone). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00551811, which also lists 1 linked publication.
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 7 Aug 2017.