AsthmaPhase 4NCT00453778
A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients
A Phase 4 study testing FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate) in people with Asthma and Mild Asthma, run by GlaxoSmithKline.
Trial summary
Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma, Mild Asthma
- What is being tested?
- FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to May 2004
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed history of asthma
- Non smoker last two years
- < 5 pack years
- FEV1 >70% of predicted
- Mild and stable asthma
- Only using short acting b2-agonist as rescue for the last 4 weeks
- Have a history of atopy.
Who cannot join
- Any significant respiratory disease, other than asthma
- Subjects with seasonal asthma may not be included if they are in their season
- Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
- Upper or lower RTI within 6 weeks
- Evidence of any disease that in the investigators mind would affect the results of the study
- Participating in another study within 4 weeks
Show all 9Show fewer
- Females who are pregnant, intend to be or who are lactating
- Methacholine PD20 > 454mcg
- Negative scin prick test
About this study
Official title: A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients
Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.
- Conditions
- Asthma, Mild Asthma
- Being tested
- FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
- Keywords
- mild asthma, FLIXOTIDE, methacholine, bronchial challenge, leukotriene D4
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
LTD4 PC20
Secondary outcomes (1)
Shift in methacholine PD20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startNov 2002
- Primary completionMay 2004
- Study completionMay 2004
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453778
- Sponsor's protocol ID
- FMS40273
- Status last verified
- Feb 2013
- First submitted
- 27 Mar 2007
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients
- ClinicalTrials.gov ID
- NCT00453778
- Acronym / sponsor ID
- FMS40273
- Conditions
- Asthma, Mild Asthma
- Keywords
- mild asthma, FLIXOTIDE, methacholine, bronchial challenge, leukotriene D4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 29 Mar 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.
Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosed history of asthma
- Non smoker last two years
- < 5 pack years
- FEV1 >70% of predicted
- Mild and stable asthma
Key exclusion criteria (9 listed)
- Any significant respiratory disease, other than asthma
- Subjects with seasonal asthma may not be included if they are in their season
- Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
- Upper or lower RTI within 6 weeks
- Evidence of any disease that in the investigators mind would affect the results of the study
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 |
|---|---|---|
| FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate) | Drug | – |
Primary outcome
LTD4 PC20
1 secondary outcome
Shift in methacholine PD20
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 12 Feb 2013.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate) in people with Asthma and Mild Asthma, run by GlaxoSmithKline.
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 7 inclusion and 9 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 12 Feb 2013. 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. 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?
LTD4 PC20. 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 12 Feb 2013.