AsthmaPhase 4NCT01635088
Onset and Duration of Mometasone by Oscillometry and Spirometry
A Phase 4 study testing Mometasone furoate 220, KoKo Spirometry and Mometasone furoate 440 in people with Asthma, run by California Allergy and Asthma Medical Group, Inc. at 1 site in United States.
Trial summary
Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects in chronic asthma. However, they also have largely unappreciated early effects when initiated as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such an early effect better than spirometry. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Mometasone furoate 220, KoKo Spirometry and Mometasone furoate 440
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years inclusive.
- Written informed consent (conducted according to the GCP and ICH guidelines) to participate in the study. Ability to comply with all study requirements.
- Mild to moderate persistent asthma with symptoms at least 2 times per week, managed by as-needed SABA only.
- A 35% or greater improvement in small airway dysfunction defined by IOS AX after inhaled SABA.
- Allergic response to one or more common allergens at screening via skin test.
- Male, or female of childbearing potential using a medically approved birth control method.
- Evidence of SAD manifested by an index of peripheral airway reactance of > 10.5 cm H2O/L (3 times the upper limit of adult normal).
- Symptoms of airflow obstruction (i.e. dyspnea on exertion greater than peers at similar exercise levels, wheeze, or cough > 3 weeks without respiratory infection, or nocturnal dyspnea, and use of SABA > 2 times per week)
Who cannot join
- Subjects with severe persistent asthma and/or subjects taking inhaled or systemic corticosteroids or long acting beta agonists (LABA).
- Subjects < 18 years of age or > 65 years.
- Pregnant or lactating females.
- History of diabetes.
- Acute infections within 4 weeks prior to Screening.
- Concurrent medical condition that might interfere with the interpretation of efficacy and safety data during the study.
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- Contraindications and warnings according to the specific label for Asmanex.
- Chronic inhaled or systemic corticosteroid treatment (> 7 consecutive days of treatment) within 30 days prior to Screening.
- Investigational drug treatment within 30 days prior to Screening. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 60 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, 90025
About this study
Official title: Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry
Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects in chronic asthma. However, they also have largely unappreciated early effects when initiated as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such an early effect better than spirometry. The investigators sought to examine the onset of action and sustained effects over 4 weeks treatment of mometasone furoate as measured by Impulse Oscillometry System (IOS) versus spirometry.
- Conditions
- Asthma
- Being tested
- Mometasone furoate 220, KoKo Spirometry, Mometasone furoate 440, Oscillometry
- Keywords
- Asthma, FEV1 and IOS change after mometasone for asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoate 220Drug
dry powder inhaler QD for 28-43 days
KoKo SpirometryDevice
Also called by Nspire
Mometasone furoate 440Drug
dry powder inhaler QD for 28-43 days
OscillometryDevice
Also called by Jaeger, MS IOS Digital
| Study group | Role | What they receive |
|---|---|---|
| Mometasone furoate 220 vs. Mometasone furoate 440 | Other | Not described Receives: Drug: Mometasone furoate 220; Drug: Mometasone furoate 440 |
| Mometasone 220 mcg vs. 440 mcg | Active comparator | Inhaled steroid Receives: Device: KoKo Spirometry; Device: Oscillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOS
Measurement of pulmonary function.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2011
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
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Allergy and Asthma Medical Group, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheldon Spector, MD, California Allergy and Asthma Medical Group, Inc.
- Investigators
- Sheldon L Spector, MD, Principal investigator, California Allergy and Asthma Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635088
- Sponsor's protocol ID
- P05285
- Status last verified
- Aug 2013
- First submitted
- 29 Jun 2012
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry
- ClinicalTrials.gov ID
- NCT01635088
- Acronym / sponsor ID
- P05285
- Conditions
- Asthma
- Keywords
- Asthma, FEV1 and IOS change after mometasone for asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- California Allergy and Asthma Medical Group, Inc.University, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- First posted
- 6 Jul 2012 (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.
Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects in chronic asthma. However, they also have largely unappreciated early effects when initiated as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such an early effect better than spirometry. The investigators sought to examine the onset of action and sustained effects over 4 weeks treatment of mometasone furoate as measured by Impulse Oscillometry System (IOS) versus spirometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone furoate 220 vs. Mometasone furoate 440 | Other | Drug: Mometasone furoate 220, Drug: Mometasone furoate 440 |
| Mometasone 220 mcg vs. 440 mcg | Active comparator | Device: KoKo Spirometry, Device: OscillometryInhaled steroid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18-65 years inclusive.
- Written informed consent (conducted according to the GCP and ICH guidelines) to participate in the study. Ability to comply with all study requirements.
- Mild to moderate persistent asthma with symptoms at least 2 times per week, managed by as-needed SABA only.
- A 35% or greater improvement in small airway dysfunction defined by IOS AX after inhaled SABA.
- Allergic response to one or more common allergens at screening via skin test.
Key exclusion criteria (9 listed)
- Subjects with severe persistent asthma and/or subjects taking inhaled or systemic corticosteroids or long acting beta agonists (LABA).
- Subjects < 18 years of age or > 65 years.
- Pregnant or lactating females.
- History of diabetes.
- Acute infections within 4 weeks prior to Screening.
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 |
|---|---|---|
| Mometasone furoate 220dry powder inhaler QD for 28-43 days | Drug | Mometasone furoate 220 vs. Mometasone furoate 440 |
| KoKo SpirometryAlso: by Nspire | Device | Mometasone 220 mcg vs. 440 mcg |
| Mometasone furoate 440dry powder inhaler QD for 28-43 days | Drug | Mometasone furoate 220 vs. Mometasone furoate 440 |
| OscillometryAlso: by Jaeger, MS IOS Digital | Device | Mometasone 220 mcg vs. 440 mcg |
Primary outcome
IOS
Time frame: 4 weeks
Measurement of pulmonary function.
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 4 Sep 2013.
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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.
Sheldon L Spector, MD principal investigator
California Allergy and Asthma Medical Group, Inc.
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 220, KoKo Spirometry and Mometasone furoate 440 in people with Asthma, run by California Allergy and Asthma Medical Group, Inc. 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 8 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 4 Sep 2013. 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.
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?
IOS (time frame: 4 weeks). 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 4 Sep 2013.