AsthmaPhase 4NCT00711165
Mometasone and Markers of Airway Inflammation
A Phase 4 study testing Mometasone Furoate in people with Asthma, run by Creighton University at 1 site in United States.
Trial summary
A post-marketing study to look at the effects of Asmanex on markers of airway inflammation. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Mometasone Furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2006
- 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asthma
- non-smoker
- FEV1 of at least 60% predicted
Who cannot join
- Pregnancy or lactation
- Corticosteroid use in past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
Official title: The Effects of Mometasone on Markers of Airway Inflammation
A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.
Read the detailed description
Patients with asthma and not treated with anti-inflammatory medications were studied. This was a parallel, randomized, placebo-controlled study to investigate the effects of Asmanex on markers of airway inflammation including exhaled nitric oxide, airway reactivity, FEV1 and nitrates/nitrites and pH in exhaled breath condensate.
- Conditions
- Asthma
- Being tested
- Placebo, Mometasone Furoate
- Keywords
- Asthma, Nitric Oxide, Exhaled Breath Condensate, Methacholine Challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 puffs, qd
Mometasone FuroateDrug
Also called asmanex
400 mcg, qd for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, 2 puffs, bid Receives: Drug: Placebo |
| Memetasone | Experimental | Mometasone Receives: Drug: Mometasone Furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Nitric Oxide
Measured: 8 weeks
Secondary outcomes (1)
Airway Reactivity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionApr 2006
- Study completionAug 2006
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 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Thomas B Casale, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711165
- Sponsor's protocol ID
- Mometasone TBC
- Status last verified
- Jul 2008
- First submitted
- 3 Jul 2008
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Mehta V, Stokes JR, Berro A, Romero FA, Casale TB. Time-dependent effects of inhaled corticosteroids on lung function, bronchial hyperresponsiveness, and airway inflammation in asthma. Ann Allergy Asthma Immunol. 2009 Jul;103(1):31-7. doi: 10.1016/S1081-1206(10)60140-8.
PubMed 19663124
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mometasone on Markers of Airway Inflammation
- ClinicalTrials.gov ID
- NCT00711165
- Acronym / sponsor ID
- Mometasone TBC
- Conditions
- Asthma
- Keywords
- Asthma, Nitric Oxide, Exhaled Breath Condensate, Methacholine Challenge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Aug 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 8 Jul 2008 (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 post-marketing study to look at the effects of Asmanex on markers of airway inflammation.
Detailed description
Patients with asthma and not treated with anti-inflammatory medications were studied. This was a parallel, randomized, placebo-controlled study to investigate the effects of Asmanex on markers of airway inflammation including exhaled nitric oxide, airway reactivity, FEV1 and nitrates/nitrites and pH in exhaled breath condensate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 2 puffs, bid |
| Memetasone | Experimental | Drug: Mometasone FuroateMometasone |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Asthma
- non-smoker
- FEV1 of at least 60% predicted
Key exclusion criteria (2 listed)
- Pregnancy or lactation
- Corticosteroid use in past 30 days
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 |
|---|---|---|
| Placebo2 puffs, qd | Drug | Placebo |
| Mometasone FuroateAlso: asmanex400 mcg, qd for 8 weeks | Drug | Memetasone |
Primary outcome
Exhaled Nitric Oxide
Time frame: 8 weeks
1 secondary outcome
Airway Reactivity
Time frame: 8 weeks
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 8 Jul 2008.
- Derived from this study: PubMed 19663124Mehta V, Stokes JR, Berro A, Romero FA, Casale TB. Time-dependent effects of inhaled corticosteroids on lung function, bronchial hyperresponsiveness, and airway inflammation in asthma. Ann Allergy Asthma Immunol. 2009 Jul;103(1):31-7. doi: 10.1016/S1081-1206(10)60140-8.
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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.
Thomas B Casale, MD principal investigator
Creighton 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 Mometasone Furoate in people with Asthma, run by Creighton University 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 3 inclusion and 2 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 8 Jul 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. Some participants in this study may receive a placebo. 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?
Exhaled Nitric Oxide (time frame: 8 weeks). 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 NCT00711165, 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 8 Jul 2008.