AsthmaPhase 4NCT00292838
Relative Potency of Inhaled Corticosteroids
A Phase 4 study testing fluticasone 25, 50, 100, 200 mcg in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- fluticasone 25, 50, 100, 200 mcg
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2001to Feb 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sputum eosinophilia >3%
- Adults age 18-70 years
- History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
- FEV1 ≥ 60% predicted
- Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
- Able to give written informed consent
Who cannot join
- Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
- Relevant seasonal allergen exposure within 4 weeks or within the course of the study
- Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
- Other respiratory diseases
- Women who are pregnant or unwilling to use appropriate contraception during the study
- Unable to withhold short-acting ß-agonist treatment for 6 hours before visit
Trial locations and contacts
1 site in 1 country.
Canada1 site
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
About this study
Official title: Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model
To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.
- Being tested
- fluticasone 25, 50, 100, 200 mcg
- Keywords
- Eosinophilic bronchitis with asthma, Eosinophilic bronchitis without asthma
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone 25, 50, 100, 200 mcgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum eosinophils
Secondary outcomes (1)
Exhaled nitric oxide, FEV1, FEF25-75%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2001
- Primary completionFeb 2007
- Study completionFeb 2007
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.
- 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Frederick E Hargreave, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292838
- Sponsor's protocol ID
- RP#01-1929
- Status last verified
- Jul 2011
- First submitted
- 14 Feb 2006
- Last updated
- 20 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model
- ClinicalTrials.gov ID
- NCT00292838
- Acronym / sponsor ID
- RP#01-1929
- Keywords
- Eosinophilic bronchitis with asthma, Eosinophilic bronchitis without asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2001
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 16 Feb 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.
To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sputum eosinophilia >3%
- Adults age 18-70 years
- History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
- FEV1 ≥ 60% predicted
- Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
Key exclusion criteria (6 listed)
- Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
- Relevant seasonal allergen exposure within 4 weeks or within the course of the study
- Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
- Other respiratory diseases
- Women who are pregnant or unwilling to use appropriate contraception during 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 |
|---|---|---|
| fluticasone 25, 50, 100, 200 mcg | Drug | – |
Primary outcome
Sputum eosinophils
1 secondary outcome
Exhaled nitric oxide, FEV1, FEF25-75%
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 20 Jul 2011.
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.
Frederick E Hargreave, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluticasone 25, 50, 100, 200 mcg in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 6 inclusion and 6 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 20 Jul 2011. 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 Canada. 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 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?
Sputum eosinophils. 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 20 Jul 2011.