AsthmaNCT01210170
Acute Effect of Mometasone on Beta-adrenergic Airway and Airway Vascular Relaxation in Severe Asthma
A study testing mometasone 400 mcg and mometasone 200 mcg in people with Asthma, run by University of Miami at 1 site in United States.
Trial summary
Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation transporters expressed by non-neuronal cells, thereby interfering with the inactivation of the organic cations by intracellular enzymes. 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 400 mcg and mometasone 200 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Inclusion Criteria:Fifteen non-smokers (males and females between the ages of 18 and 65 years) with physician-diagnosed moderate persistent asthma and FEV1 < 75% of predicted.
Exclusion Criteria:Cardiovascular disease and use of cardiovascular medications, pregnancy, use of oral controller medication for asthma (methylxanthines, systemic glucocorticosteroids, leukotriene modifiers), an acute respiratory infection within 4 weeks before enrollment
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Research Laboratory- University of Miami School of Medicine
Miami, Florida, 33136
About this study
Official title: Acute Effect of Mometasone Furoate DPI on Beta-adrenergic Airway and Airway Vascular Relaxation in Moderately Severe Asthma
Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation transporters expressed by non-neuronal cells, thereby interfering with the inactivation of the organic cations by intracellular enzymes. Beta2-adrenergic agonists are organic cations, and the concentration of inhaled beta2-adrenergic agonists at beta2-adrenergic receptor sites on smooth muscle is likely to be increased by inhaled glucocorticosteroids (ICS) by the ICS' effect on the glucocorticosteroid-sensitive organic cation transporters. The investigators have shown in human airway vascular smooth muscle cells that the glucocorticosteroid action on organic cation uptake occurs within minutes, does not involve gene transcription or protein synthesis, is not mediated through classical steroid receptors, and is cell membrane-linked.
In the present proposal, the investigators wish to use different single doses of mometasone, a clinically effective ICS, administered with or at different times before albuterol inhalation in subjects with moderate persistent asthma who are obstructed at the time of study.
Read more
With this approach the investigators will test the hypothesis that a single inhalation of mometasone causes an acute, transient, dose-dependent potentiation of beta2-adrenergic bronchodilation.
If the hypothesis that a single dose of mometasone acutely potentiates beta2-adrenergic bronchodilation is correct, the results would have a significant impact on treatment strategies involving ICSs and beta2-adrenergic agonists in patients with asthma.
Read the detailed description
Fifteen non-smokers (males and females between the ages of 18 and 65 years) with physician-diagnosed moderate persistent asthma will be recruited for the study. The subjects will be allowed to use inhaled controller (including ICS) and rescue medication. At study entry, all asthmatic subjects must be clinically stable, and have a forced pre-bronchodilator one-second expired volume (FEV1) of < 75% predicted.
Approval for the protocol will be requested from the University of Miami Institutional Review Board. All subjects will provide written informed consent.
Exclusion criteria:
- Cardiovascular disease and use of cardiovascular medications
- Pregnancy
- Use of oral controller medication for asthma (methylxanthines, systemic glucocorticosteroids, leukotriene modifiers)
- An acute respiratory infection within 4 weeks before enrollment.
Each subject will make 8 visits to the research laboratory.
Procedures:
Visit 1 (screening visit): On this visit, after having signed the consent form, the subjects will perform spirometry before and 15 min after inhaling 180 µg albuterol from a HFA-MDI using a spacer.
Visit 2-8:Subjects that qualify for the study will be asked to return for 7 more visits for the following treatment protocols:
- Inhalation of 400 µg mometasone 30 min before inhalation of 180 µg albuterol
- Inhalation of mometasone placebo 30 min before inhalation of 180 µg albuterol
- Simultaneous inhalation of 400 µg mometasone and 180 µg albuterol
- Simultaneous inhalation of mometasone placebo and 180 µg albuterol
Systemic blood pressure, pulse, O2 saturation, spirometry and airway blood flow ( Qaw) will be measured before mometasone or placebo inhalation, and before and 15 min after albuterol inhalation except on the day when mometasone and albuterol are co-administered; on that day the measurements will be made before and 15 min after the mometasone/albuterol co-administration.
- Conditions
- Asthma
- Being tested
- placebo, mometasone 400 mcg, mometasone 200 mcg
- Keywords
- asthma,, inhaled corticosteroids,, airway blood flow,, mometasone,, albuterol, spirometry
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called Asmanex placebo
placebo inhalation before albuterol.
mometasone 400 mcgDrug
Also called Asmanex
mometasone inhalation before albuterol.
mometasone 200 mcgDrug
Also called Asmanex
200ug mometasone before albuterol.
| Study group | Role | What they receive |
|---|---|---|
| mometasone 400 mcg - 30 min | Experimental | randomly assigned intervention Receives: Drug: mometasone 400 mcg |
| mometasone 400 mcg simultaneous | Experimental | randomly assigned intervention Receives: Drug: mometasone 400 mcg |
| placebo- 30 min | Placebo comparator | randomly assigned intervention Receives: Drug: placebo |
| placebo simultaneous | Placebo comparator | randomly assigned intervention Receives: Drug: placebo |
| mometasone 400 mcg - 60 min | Experimental | randomly assigned intervention Receives: Drug: mometasone 400 mcg |
| placebo- 60 min | Placebo comparator | randomly assigned intervention Receives: Drug: placebo |
| mometasone 200 mcg - 30 min | Experimental | randomly assigned intervention Receives: Drug: mometasone 200 mcg |
| mometasone 200 mcg - 60 min | Experimental | randomly assigned intervention Receives: Drug: mometasone 200 mcg |
| mometasone 200 mcg simultaneous | Experimental | randomly assigned intervention Receives: Drug: mometasone 200 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albuterol-induced Change in FEV1
FEV1 will be measured before and after inhalation of 180 mcg albuterol.
Measured: 15 minutes after albuterol inhalation
Secondary outcomes (1)
Albuterol Induced Percent Change in Qaw
Qaw will be measured before and 15 min after albuterol inhalation
Measured: change in Qaw 15 minutes after albuterol inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Adam Wanner, University of Miami
- Investigators
- Adam Wanner, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210170
- Sponsor's protocol ID
- 20071188
- Other IDs
- P05299
- Status last verified
- Oct 2017
- First submitted
- 27 Sep 2010
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mendes ES, Cadet L, Arana J, Wanner A. Acute effect of an inhaled glucocorticosteroid on albuterol-induced bronchodilation in patients with moderately severe asthma. Chest. 2015 Apr;147(4):1037-1042. doi: 10.1378/chest.14-1742.
PubMed 25611803
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Mometasone Furoate DPI on Beta-adrenergic Airway and Airway Vascular Relaxation in Moderately Severe Asthma
- ClinicalTrials.gov ID
- NCT01210170
- Acronym / sponsor ID
- 20071188
- Conditions
- Asthma
- Keywords
- asthma,, inhaled corticosteroids,, airway blood flow,, mometasone,, albuterol, spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Posted 19 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glucocorticosteroids inhibit the disposal of organic cations by blocking organic cation transporters expressed by non-neuronal cells, thereby interfering with the inactivation of the organic cations by intracellular enzymes. Beta2-adrenergic agonists are organic cations, and the concentration of inhaled beta2-adrenergic agonists at beta2-adrenergic receptor sites on smooth muscle is likely to be increased by inhaled glucocorticosteroids (ICS) by the ICS' effect on the glucocorticosteroid-sensitive organic cation transporters. The investigators have shown in human airway vascular smooth muscle cells that the glucocorticosteroid action on organic cation uptake occurs within minutes, does not involve gene transcription or protein synthesis, is not mediated through classical steroid receptors, and is cell membrane-linked.
In the present proposal, the investigators wish to use different single doses of mometasone, a clinically effective ICS, administered with or at different times before albuterol inhalation in subjects with moderate persistent asthma who are obstructed at the time of study.
With this approach the investigators will test the hypothesis that a single inhalation of mometasone causes an acute, transient, dose-dependent potentiation of beta2-adrenergic bronchodilation.
If the hypothesis that a single dose of mometasone acutely potentiates beta2-adrenergic bronchodilation is correct, the results would have a significant impact on treatment strategies involving ICSs and beta2-adrenergic agonists in patients with asthma.
Detailed description
Fifteen non-smokers (males and females between the ages of 18 and 65 years) with physician-diagnosed moderate persistent asthma will be recruited for the study. The subjects will be allowed to use inhaled controller (including ICS) and rescue medication. At study entry, all asthmatic subjects must be clinically stable, and have a forced pre-bronchodilator one-second expired volume (FEV1) of < 75% predicted.
Approval for the protocol will be requested from the University of Miami Institutional Review Board. All subjects will provide written informed consent.
Exclusion criteria:
- Cardiovascular disease and use of cardiovascular medications
- Pregnancy
- Use of oral controller medication for asthma (methylxanthines, systemic glucocorticosteroids, leukotriene modifiers)
- An acute respiratory infection within 4 weeks before enrollment.
Each subject will make 8 visits to the research laboratory.
Procedures:
Visit 1 (screening visit): On this visit, after having signed the consent form, the subjects will perform spirometry before and 15 min after inhaling 180 µg albuterol from a HFA-MDI using a spacer.
Visit 2-8:Subjects that qualify for the study will be asked to return for 7 more visits for the following treatment protocols:
- Inhalation of 400 µg mometasone 30 min before inhalation of 180 µg albuterol
- Inhalation of mometasone placebo 30 min before inhalation of 180 µg albuterol
- Simultaneous inhalation of 400 µg mometasone and 180 µg albuterol
- Simultaneous inhalation of mometasone placebo and 180 µg albuterol
Systemic blood pressure, pulse, O2 saturation, spirometry and airway blood flow ( Qaw) will be measured before mometasone or placebo inhalation, and before and 15 min after albuterol inhalation except on the day when mometasone and albuterol are co-administered; on that day the measurements will be made before and 15 min after the mometasone/albuterol co-administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| mometasone 400 mcg - 30 min | Experimental | Drug: mometasone 400 mcgrandomly assigned intervention |
| mometasone 400 mcg simultaneous | Experimental | Drug: mometasone 400 mcgrandomly assigned intervention |
| placebo- 30 min | Placebo comparator | Drug: placeborandomly assigned intervention |
| placebo simultaneous | Placebo comparator | Drug: placeborandomly assigned intervention |
| mometasone 400 mcg - 60 min | Experimental | Drug: mometasone 400 mcgrandomly assigned intervention |
| placebo- 60 min | Placebo comparator | Drug: placeborandomly assigned intervention |
| mometasone 200 mcg - 30 min | Experimental | Drug: mometasone 200 mcgrandomly assigned intervention |
| mometasone 200 mcg - 60 min | Experimental | Drug: mometasone 200 mcgrandomly assigned intervention |
| mometasone 200 mcg simultaneous | Experimental | Drug: mometasone 200 mcgrandomly assigned intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| placeboAlso: Asmanex placeboplacebo inhalation before albuterol. | Drug | placebo simultaneous, placebo- 30 min, placebo- 60 min |
| mometasone 400 mcgAlso: Asmanexmometasone inhalation before albuterol. | Drug | mometasone 400 mcg - 30 min, mometasone 400 mcg - 60 min, mometasone 400 mcg simultaneous |
| mometasone 200 mcgAlso: Asmanex200ug mometasone before albuterol. | Drug | mometasone 200 mcg - 30 min, mometasone 200 mcg - 60 min, mometasone 200 mcg simultaneous |
Primary outcome
Albuterol-induced Change in FEV1
Time frame: 15 minutes after albuterol inhalation
FEV1 will be measured before and after inhalation of 180 mcg albuterol.
1 secondary outcome
Albuterol Induced Percent Change in Qaw
Time frame: change in Qaw 15 minutes after albuterol inhalation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25611803Mendes ES, Cadet L, Arana J, Wanner A. Acute effect of an inhaled glucocorticosteroid on albuterol-induced bronchodilation in patients with moderately severe asthma. Chest. 2015 Apr;147(4):1037-1042. doi: 10.1378/chest.14-1742.
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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.
Adam Wanner principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mometasone 400 mcg and mometasone 200 mcg in people with Asthma, run by University of Miami 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?
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 21 Nov 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Albuterol-induced Change in FEV1 (time frame: 15 minutes after albuterol inhalation). 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 NCT01210170, 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 21 Nov 2017.