AsthmaNCT00331292
A Methodology Study To Look At Genes In Lung Cells And Tissue From Asthmatic Patients
An observational study of Asthma, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The primary goal of this study is to identify a gene or panel of genes which are differentially expressed in lung cells and tissue from asthmatic patients following administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject in this study will undergo two bronchoscopies. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to not given
- Phase
- Observational
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a history of intermittant asthma.
- Have asthma symptoms less than once per week.
- Have no other significant disease.
- Do not take regular oral or inhaled steroids.
- Are a non-smoker for the past 12 months with a pack history of less than 5 years.
Who cannot join
- Have a history of drug or alcohol abuse.
- Have poorly controlled asthma or a history of life-threatening asthma.
- Have a history of hypersensitivity to bronchodilators.
- Are unable to abstain from inhaled steroids from 14 days prior to the first study visit until completion of the study.
- Have received oral steroids within 3 months of study entry.
- Have been hospitalized for your asthma within 3 months of study entry.
- Have had treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Study to Identify a Transcriptomic Profile Indicative of Cycle AMP Pathway Activation in the Lung
The primary goal of this study is to identify a gene or panel of genes which are differentially expressed in lung cells and tissue from asthmatic patients following administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject in this study will undergo two bronchoscopies.
- Conditions
- Asthma
- Keywords
- Asthma bronchoscopy
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331292
- Sponsor's protocol ID
- CRB100706
- Status last verified
- Oct 2008
- First submitted
- 26 May 2006
- Last updated
- 16 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Identify a Transcriptomic Profile Indicative of Cycle AMP Pathway Activation in the Lung
- ClinicalTrials.gov ID
- NCT00331292
- Acronym / sponsor ID
- CRB100706
- Conditions
- Asthma
- Keywords
- Asthma bronchoscopy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- First posted
- 29 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 primary goal of this study is to identify a gene or panel of genes which are differentially expressed in lung cells and tissue from asthmatic patients following administration of Ipratropium bromide and eiTher nebulised Albuterol or saline. Each subject in this study will undergo two bronchoscopies.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a history of intermittant asthma.
- Have asthma symptoms less than once per week.
- Have no other significant disease.
- Do not take regular oral or inhaled steroids.
- Are a non-smoker for the past 12 months with a pack history of less than 5 years.
Key exclusion criteria (7 listed)
- Have a history of drug or alcohol abuse.
- Have poorly controlled asthma or a history of life-threatening asthma.
- Have a history of hypersensitivity to bronchodilators.
- Are unable to abstain from inhaled steroids from 14 days prior to the first study visit until completion of the study.
- Have received oral steroids within 3 months of study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2008.
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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, MD study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Oct 2008. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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.
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 16 Oct 2008.