AsthmaPhase 4MeCISNCT00705341
MethaCholine Bronchoprovocation Study (MeCIS)
A Phase 4 study testing fluticasone in people with Asthma, run by Johns Hopkins Bloomberg School of Public Health at 13 sites in United States.
Trial summary
The purpose of this research is to evaluate the methacholine challenge test as an accurate indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares methacholine challenge test results from asthma patients to those from people who do not have asthma. Read more about this study
- Who is it for?
- Ages 12 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2009to Feb 2010
- Phase
- Phase 4
- 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 12 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males or females greater than or equal to 12 and less than 70 years of age
- Physician-diagnosed and investigator-confirmed stable asthma (excluding exercise induced asthma)
- Current treatment for asthma by a healthcare provider within the preceding twelve months: current asthma treatment defined as regular use of asthma medications. Asthma medications include short and long acting adrenergic bronchodilators, bronchodilator combinations, inhaled anticholinergics, inhaled corticosteroids, cromolyn sodium and nedocromil, leukotriene modifiers and methylxanthines
- Stable asthma defined by no asthma exacerbation (emergency room visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks
- Forced expiratory volume at one second (FEV1) >70% predicted pre-bronchodilator
- Ability to provide screening and baseline information
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- Ability and willingness to provide informed consent
- For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study
- Males or females greater than or equal to 12 and less than 70 years of age
- Individuals who are in good overall health
- Age (within ten years for above 25 years of age and +/- five years for 12-25 years of age) and sex matched to the asthmatic group
Who cannot join
- Chronic oral steroid therapy (daily)
- Oral corticosteroid use within past 4 weeks
- Respiratory tract infection within past 4 weeks
- Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency
- Known allergy to methacholine (for example, a previous bad reaction to methacholine) or to any other parasympathomimetic agents
- Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).
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- History of epilepsy, cardiovascular disease with bradycardia (slow heart beat), vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction
- History of cigarette smoking within the past 5 years or >10 pack years total
- Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study
- Any condition or compliance issue which in the opinion of the investigator might interfere with participation
- Nonasthmatic control criteria:
- A subject will be excluded if there is a history within the previous 5 years of:
- clinically diagnosed allergy (allergic rhinitis, hay fever or atopic dermatitis),
- asthma (beyond 6 years of age),
- chronic nasal or sinus disease, or
- other chronic lung diseases
- Respiratory tract infection within past 4 weeks
- History of cigarette smoking within the past 5 years or >10 pack years total
- Known allergy to methacholine (for example, a previous bad reaction to methacholine) or to any other parasympathomimetic agents
- Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).
- History of epilepsy, cardiovascular disease with bradycardia (slow heart beat), vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Vermont Lung Center at the University of Vermont
Burlington, Vermont, 05405
Northwestern University Memorial Hospital
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Indiana University
Indianapolis, Indiana, 46202
The Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Missouri-Kansas City
Kansas City, Missouri, 64108
University of Miami/Univestiy of South Florida
Miami, Florida, 33136
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Louisianna State University
New Orleans, Louisiana, 70112
New York Consortium/Columbia University
New York, New York, 10016
University of California at San Diego
San Diego, California, 92103
Washington University School of Medicine
St Louis, Missouri, 631110
New York Medical College
Valhalla, New York, 10595
About this study
Official title: MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study
The purpose of this research is to evaluate the methacholine challenge test as an accurate indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares methacholine challenge test results from asthma patients to those from people who do not have asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid will be compared to results on high dose inhaled corticosteroids. Both males and females with stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will be between 12 and 69 years of age.
Read the detailed description
The study consists of two phases. The first phase is a cross-sectional, case-control study measuring the sensitivity and specificity of methacholine challenge testing for differentiating asthmatic participants from non-asthmatic controls. The second phase is a cross-over, randomized, double-masked trial designed to evaluate the impact of high dose versus low dose inhaled corticosteroids (ICS) on bronchial hyperreactivity (BHR) in asthmatics.
- Conditions
- Asthma
- Being tested
- fluticasone
- Keywords
- Normal Controls
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasoneDrug
Also called Flovent diskus
Inhaled corticosteroid approved for treatment of asthma
| Study group | Role | What they receive |
|---|---|---|
| Low dose fluticasone for phase 2 | Active comparator | For people with asthma, fluticasone at 250 mcg per day; phase 2 of study Receives: Drug: fluticasone |
| High dose fluticasone for phase 2 | Active comparator | For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study Receives: Drug: fluticasone |
| Nonasthmatic controls for phase 1 | No intervention | People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study |
| Asthmatic controls for phase 1 | No intervention | People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine Challenge Test Result for Phase 2
Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks
Measured: weeks 0, 4
Secondary outcomes (1)
Predictive Value of Methacholine Challenge Test for Phase 1
Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls
Measured: one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, St. Louis University, Long Island Jewish Medical Center, North Shore University Hospital, Baylor College of Medicine, University of Vermont, Nemours Children's Clinic, University of Florida, Indiana University, Ohio State University, NYU Langone Health, University of Missouri-Columbia, Northwestern University, Louisiana State University Health Sciences Center in New Orleans, University of Miami, University of South Florida, University of California, San Diego, National Jewish Health, Duke University
- Responsible party
- Principal investigator, Janet Holbrook, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Kaharu Sumino, MD, Principal investigator, St. Louis Asthma Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705341
- Sponsor's protocol ID
- ALAACRC07
- Acronym
- MeCIS
- Status last verified
- Feb 2013
- First submitted
- 24 Jun 2008
- Last updated
- 12 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sumino K, Sugar EA, Irvin CG, Kaminsky DA, Shade D, Wei CY, Holbrook JT, Wise RA, Castro M; American Lung Association Asthma Clinical Research Centers. Methacholine challenge test: diagnostic characteristics in asthmatic patients receiving controller medications. J Allergy Clin Immunol. 2012 Jul;130(1):69-75.e6. doi: 10.1016/j.jaci.2012.02.025. Epub 2012 Apr 1.
PubMed 22465214
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
- MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study
- ClinicalTrials.gov ID
- NCT00705341
- Acronym / sponsor ID
- MeCIS / ALAACRC07
- Conditions
- Asthma
- Keywords
- Normal Controls
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, St. Louis University, Long Island Jewish Medical Center, North Shore University Hospital, Baylor College of Medicine, University of Vermont, Nemours Children's Clinic, University of Florida, Indiana University, Ohio State University, NYU Langone Health, University of Missouri-Columbia, Northwestern University, Louisiana State University Health Sciences Center in New Orleans, University of Miami, University of South Florida, University of California, San Diego, National Jewish Health, Duke University
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 12 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the methacholine challenge test as an accurate indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares methacholine challenge test results from asthma patients to those from people who do not have asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid will be compared to results on high dose inhaled corticosteroids. Both males and females with stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will be between 12 and 69 years of age.
Detailed description
The study consists of two phases. The first phase is a cross-sectional, case-control study measuring the sensitivity and specificity of methacholine challenge testing for differentiating asthmatic participants from non-asthmatic controls. The second phase is a cross-over, randomized, double-masked trial designed to evaluate the impact of high dose versus low dose inhaled corticosteroids (ICS) on bronchial hyperreactivity (BHR) in asthmatics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose fluticasone for phase 2 | Active comparator | Drug: fluticasoneFor people with asthma, fluticasone at 250 mcg per day; phase 2 of study |
| High dose fluticasone for phase 2 | Active comparator | Drug: fluticasoneFor people with asthma, fluticasone at 1000 mcg per day; phase 2 of study |
| Nonasthmatic controls for phase 1 | No intervention | –People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study |
| Asthmatic controls for phase 1 | No intervention | –People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study |
Who may qualify
- Ages
- 12 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females greater than or equal to 12 and less than 70 years of age
- Physician-diagnosed and investigator-confirmed stable asthma (excluding exercise induced asthma)
- Current treatment for asthma by a healthcare provider within the preceding twelve months: current asthma treatment defined as regular use of asthma medications. Asthma medications include short and long acting adrenergic bronchodilators, bronchodilator combinations, inhaled anticholinergics, inhaled corticosteroids, cromolyn sodium and nedocromil, leukotriene modifiers and methylxanthines
- Stable asthma defined by no asthma exacerbation (emergency room visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks
- Forced expiratory volume at one second (FEV1) >70% predicted pre-bronchodilator
Key exclusion criteria (21 listed)
- Chronic oral steroid therapy (daily)
- Oral corticosteroid use within past 4 weeks
- Respiratory tract infection within past 4 weeks
- Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency
- Known allergy to methacholine (for example, a previous bad reaction to methacholine) or to any other parasympathomimetic agents
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 |
|---|---|---|
| fluticasoneAlso: Flovent diskusInhaled corticosteroid approved for treatment of asthma | Drug | High dose fluticasone for phase 2, Low dose fluticasone for phase 2 |
Primary outcome
Methacholine Challenge Test Result for Phase 2
Time frame: weeks 0, 4
Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks
1 secondary outcome
Predictive Value of Methacholine Challenge Test for Phase 1
Time frame: one time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22465214Sumino K, Sugar EA, Irvin CG, Kaminsky DA, Shade D, Wei CY, Holbrook JT, Wise RA, Castro M; American Lung Association Asthma Clinical Research Centers. Methacholine challenge test: diagnostic characteristics in asthmatic patients receiving controller medications. J Allergy Clin Immunol. 2012 Jul;130(1):69-75.e6. doi: 10.1016/j.jaci.2012.02.025. Epub 2012 Apr 1.
- Asthma Clinical Research Centers websiteLink provided by the sponsor.
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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.
Kaharu Sumino, MD principal investigator
St. Louis Asthma Clinical Research Center
13 sites 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 in people with Asthma, run by Johns Hopkins Bloomberg School of Public Health at 13 sites 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 11 inclusion and 21 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.
Where is the study taking place?
The record lists 13 sites 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?
Yes. Results are posted in the registry (first posted 12 Feb 2013). 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?
Methacholine Challenge Test Result for Phase 2 (time frame: weeks 0, 4). 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 NCT00705341, 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 12 Feb 2013.