AsthmaPhase 1NCT00318630
The Effect Of AVANDIA On The Late Asthmatic Response
A Phase 1 study testing Rosiglitazone in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
Trial summary
This study is to investigate the effects of AVANDIA on the asthmatic response. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Rosiglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNew Zealand
- Study dates
- 22 Jul 2005to 30 Jun 2006
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild asthmatic treated with short-acting beta agonists only, non-smoker.
Who cannot join
- Inability to abstain from medications other than short-acting beta agonists and paracetamol.
- Recent administration of steroids.
- Recent respiratory infection or exacerbation of asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double-blind Two-period Crossover Study to Investigate the Effect of Treatment With Repeat Doses of a PPAR Gamma Agonist on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma Compared With Repeat Doses of Placebo
This study is to investigate the effects of AVANDIA on the asthmatic response.
- Conditions
- Asthma
- Being tested
- Rosiglitazone, Placebo
- Keywords
- Asthma AVANDIA Inflammation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.
PlaceboDrug
Subjects will also receive placebo oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment 1 | Experimental | Eligible subjects will receive rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily administered orally for 28 days followed by placebo oral tablet. Receives: Drug: Rosiglitazone; Drug: Placebo |
| Subjects receiving treatment 2 | Experimental | Eligible subjects will receive placebo oral tablet followed by rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily for 28 days. Receives: Drug: Rosiglitazone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing.
Measured: Up to 43 days
Secondary outcomes (1)
The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.
Measured: Up to 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study start22 Jul 2005
- Primary completion30 Jun 2006
- Study completion30 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 26 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
- NCT00318630
- Sponsor's protocol ID
- 104385
- Status last verified
- Sep 2017
- First submitted
- 25 Apr 2006
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
This study has not been published in the scientific literature.
Richards DB, Bareille P, Lindo EL, Quinn D, Farrow SN. Treatment with a peroxisomal proliferator activated receptor gamma agonist has a modest effect in the allergen challenge model in asthma: a randomised controlled trial. Respir Med. 2010 May;104(5):668-74. doi: 10.1016/j.rmed.2009.11.006. Epub 2009 Nov 26.
PubMed 19944580
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Two-period Crossover Study to Investigate the Effect of Treatment With Repeat Doses of a PPAR Gamma Agonist on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma Compared With Repeat Doses of Placebo
- ClinicalTrials.gov ID
- NCT00318630
- Acronym / sponsor ID
- 104385
- Conditions
- Asthma
- Keywords
- Asthma AVANDIA Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2005 (actual)
- Primary completion
- 30 Jun 2006 (actual)
- Study completion
- 30 Jun 2006 (actual)
- First posted
- 27 Apr 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.
This study is to investigate the effects of AVANDIA on the asthmatic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment 1 | Experimental | Drug: Rosiglitazone, Drug: PlaceboEligible subjects will receive rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily administered orally for 28 days followed by placebo oral tablet. |
| Subjects receiving treatment 2 | Experimental | Drug: Rosiglitazone, Drug: PlaceboEligible subjects will receive placebo oral tablet followed by rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily for 28 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mild asthmatic treated with short-acting beta agonists only, non-smoker.
Key exclusion criteria (3 listed)
- Inability to abstain from medications other than short-acting beta agonists and paracetamol.
- Recent administration of steroids.
- Recent respiratory infection or exacerbation of asthma.
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 |
|---|---|---|
| RosiglitazoneRosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days. | Drug | Subjects receiving treatment 1, Subjects receiving treatment 2 |
| PlaceboSubjects will also receive placebo oral tablet. | Drug | Subjects receiving treatment 1, Subjects receiving treatment 2 |
Primary outcome
The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing.
Time frame: Up to 43 days
1 secondary outcome
The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.
Time frame: Up to 43 days
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 25 Sep 2017.
- BackgroundThis study has not been published in the scientific literature.
- Derived from this study: PubMed 19944580Richards DB, Bareille P, Lindo EL, Quinn D, Farrow SN. Treatment with a peroxisomal proliferator activated receptor gamma agonist has a modest effect in the allergen challenge model in asthma: a randomised controlled trial. Respir Med. 2010 May;104(5):668-74. doi: 10.1016/j.rmed.2009.11.006. Epub 2009 Nov 26.
- Results for study 104385 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 Rosiglitazone in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
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 1 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 25 Sep 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 New Zealand. 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?
The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing. (time frame: Up to 43 days). 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 NCT00318630, which also lists 2 linked publications.
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 25 Sep 2017.