AsthmaPhase 3MISTNCT00675584
CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
A Phase 3 study testing Budesonide in people with Asthma, run by Milton S. Hershey Medical Center at 5 sites in United States.
Trial summary
Asthma affects about 4 million children in the United States and is a leading cause of hospitalizations and school absenteeism. Continuous wheezing in very young children may develop into asthma. Read more about this study
- Who is it for?
- Ages 12 to 53 months
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2008to Jul 2010
- Phase
- Phase 3
- 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 53 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants who meet all of the following criteria are eligible for study entry. Participants may be reassessed if not initially eligible.
- Positive asthma predictive index (API) status
- A history of at least 4 wheezing episodes in the prior year with at least one physician diagnosed or at least 3 wheezing episodes in the prior year with at least one physician diagnosed and at least 3 months of asthma controller therapy in the prior year
- Experienced a severe exacerbation requiring systemic corticosteroids, urgent unscheduled or emergency visit, or hospitalization in the 12 months before the screening visit
- All immunizations must be completed, including varicella (unless the child has already had clinical varicella). If the child needs the varicella vaccine, this will be arranged with the primary care physician and must be received before study entry.
- Allows blood to be used for genetic analysis
- Willingness to provide informed consent by the child's parent or guardian
Who cannot join
- Participants who meet any of the following criteria are NOT eligible for enrollment, but they may be re-enrolled if these exclusion criteria disappear:
- Use of more than six courses of systemic corticosteroids in the 12 months before the screening visit
- More than two hospitalizations for wheezing illnesses in the 12 months before the screening visit
- Use of oral or systemic corticosteroids in the 2 weeks before the screening visit
- Current treatment with antibiotics for diagnosed sinus disease
- Current participation or has participated in the month before the screening visit in another investigational drug trial
Show all 24Show fewer
- Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion
- Medically unable to use systemic corticosteroids
- Clinically relevant gastroesophageal reflux
- Inability of the child to cooperate with nebulizer therapy
- Participants who meet any of the following criteria are NOT eligible for enrollment, and they may not be re-enrolled:
- Gestation less than late preterm, as defined as birth before 34 weeks gestational age
- Significant developmental delay/failure to thrive, defined as crossing of two major percentile lines during the last year for age and gender. If a child plots less than the 10th percentile for age and gender, a growth chart for the previous year will be obtained from the child's primary care provider.
- Head circumference less than the 3rd percentile or greater than the 97th percentile unless medical evaluation documents no associated illness
- Presence of lung disease other than asthma, such as cystic fibrosis and bronchopulmonary dysplasia (BPD). Evaluation during the screening process will assure that an adequate evaluation of other lung diseases has been performed.
- Presence of other significant medical illnesses (e.g., cardiac, liver, gastrointestinal, endocrine) that would place the child at increased risk of participating in the study
- Immunodeficiency disorders
- History of respiratory failure requiring mechanical ventilation
- History of hypoxic seizure
- History of significant adverse reaction to any study medication ingredient
- Participants will be ineligible to continue in the study and be randomly assigned to a treatment group if any of the following is documented during the 2-week observation period, but they may be re-enrolled if these exclusion criteria disappear:
- Persistent symptomatic asthma, as defined as experiencing symptoms requiring albuterol use on average three or more days per week or two or more night time awakenings due to asthma-associated symptoms
- Inadequate adherence (less than 75% of days) to diary card completion or nebulizer medication use
- Use of any asthma medication except albuterol (used on as needed basis)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
National Jewish Medical and Research Center
Denver, Colorado, 80206
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Kaiser Permanente Medical Center
San Diego, California, 92111
Washington University School of Medicine
St Louis, Missouri, 63110
University of Arizona College of Medicine
Tucson, Arizona, 85724
About this study
Official title: Childhood Asthma Research and Education (CARE) Network Trial - Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
Asthma affects about 4 million children in the United States and is a leading cause of hospitalizations and school absenteeism. Continuous wheezing in very young children may develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to treat children with particularly bad wheezing episodes. This study will compare the safety and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only during respiratory tract illnesses for toddlers with continuous wheezing or coughing illnesses.
Read the detailed description
Childhood asthma can be caused by many factors, including allergens, cigarette smoke, air pollution, or infections. Symptoms include wheezing, shortness of breath, chest tightness, and coughing. Wheezing illnesses are common during the first several years of life, and continuous wheezing, or recurrent intermittent wheezing, may be an indicator of asthma. Recurrent intermittent wheezing can also lead to breathing difficulties, sleep disturbances, and severe exacerbations that result in emergency department visits, hospitalizations, or even death. The Prevention of Early Asthma in Kids (PEAK) and Acute Intervention Management Strategies (AIMS) studies, both of which are part of the Childhood Asthma Research and Education (CARE) Network, as well as several other studies, have identified therapies that may improve recurrent wheezing in young children. This study will compare the safety and effectiveness of two treatment regimens-low doses of ICS taken on a daily basis versus higher doses of ICS taken only during respiratory tract illnesses-at improving recurrent wheezing in toddlers. Study researchers will also identify individual characteristics (e.g., age, gender, family history of asthma and allergies, the degree of allergy, genetics) that may be associated with treatment response. Lastly, the relationship of virus infections to respiratory illnesses, wheezing episodes, and response to study treatments will also be studied.
This study will enroll children between 12 and 53 months of age who have experienced episodes of wheezing or coughing in the year before study entry, with at least one episode that required one of the following: oral steroids, an urgent unscheduled medical visit, an emergency room visit, or hospitalization. This study will begin with a 2-week evaluation period during which potential participants will receive placebo once a day. Parents will document their child's asthma symptoms and medication use in a daily diary. Next, at a baseline study visit, eligible participants will be randomly assigned to one of the following two 12-month treatment groups:
- Group 1 participants will receive a low dose of ICS once a day at night, except during respiratory tract illnesses. During a respiratory tract illness, participants will receive placebo each morning and a low dose of ICS each night for 7 days.
- Group 2 participants will receive a high dose of ICS twice a day for 7 days during each respiratory illness and placebo once a day at night at all other times.
Throughout the 12 months of treatment, all participants will receive albuterol to treat respiratory symptoms and prednisolone if asthma symptoms worsen. Parents will be given an action plan to help manage their child's symptoms, and during respiratory illnesses, parents will contact study researchers to determine the best treatment plan. Study visits will occur at baseline and Weeks 4, 12, 20, 28, 36, 44, and 52. Participants' parents will take part in scheduled telephone interviews one month after each clinic visit to provide information on their child's asthma symptoms, study medication use, and health problems. Most study visits will include a physical exam and lung function testing. At select study visits, the following will occur: allergy skin testing, blood collection, nasal mucus sampling, and parent questionnaires to assess asthma, quality of life, and environmental factors. A portion of the participants' blood will undergo genetic analysis; a blood collection from parents for genetic analysis will be optional. Throughout the treatment period, participants' parents will record asthma symptoms and medication usage in a daily diary.
- Conditions
- Asthma
- Being tested
- Budesonide, Placebo Budesonide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Pulmicort Respules®
Participants in Arm 1 will receive 0.5 mg of budesonide once a day. Participants in Arm 2 will receive 1 mg of budesonide twice a day for 7 days at the onset of respiratory tract illnesses.
Placebo BudesonideDrug
Also called Placebo Pulmicort Respules®
Participants in Arm 1 will receive placebo budesonide each morning during respiratory tract illnesses for 7 days. Participants in Arm 2 will receive placebo budesonide once a day for the entire study, other than when they have a respiratory tract illness.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Budesonide | Active comparator | Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days. Receives: Drug: Budesonide; Drug: Placebo Budesonide |
| Budesonide | Experimental | Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study. Receives: Drug: Budesonide; Drug: Placebo Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Exacerbations Requiring Systemic Corticosteroids
The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up
Measured: Measured during the 12-month follow-up period
Secondary outcomes (10)
Proportion of Episode-free Days
An episode-free day consisted of no asthma symptoms and no asthma rescue medications
Measured: Measured during the 12-month follow-up period
Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months
Measured: Measured during the 12-month follow-up period
Number of Participants With Treatment Failure
Treatment failure was defined as the occurrence of at least one of the following events:
- four courses of systemic corticosteroids
- one hospitalization for acute exacerbation of wheezing
- hypoxic seizure during an acute exacerbation of asthma/wheezing
- intubation for acute asthma/wheezing
- serious adverse event related to a study medication
- physician discretion with specific rationale
Measured: Measured during the 12-month follow-up period
Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO)
Exhaled nitric oxide (eNO) is measured in parts per billion, and the change constructed between 12 months and baseline
Measured: baseline and 12 months
Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry
Measured: baseline and 12 months
Adverse Events Associated With Corticosteroid Use
Measured: Measured during the 12-month follow-up period
Number of Days of Absence From Daycare and Preschool for the Child and From Work for the Caregiver Per 12 Months
Measured: Measured during the 12-month follow-up period
Proportion of Days With Rescue Albuterol Use
Measured: Measured during the 12-month follow-up period
Change in Wheeze Severity During a Respiratory Tract Illness
Wheeze severity is scored as 0 (none) to 5 (very severe) during a respiratory tract illness
Measured: Measured during the first seven days for each respiratory tract illness
Change Between 12 Months and Baseline in the Caregiver Quality-of-life
The caregiver quality-of-life questionnaire consists of seven questions, each scored from 0 (worse) to 3 (best), and all seven questions are summed to yield a total score ranging from 0 to 21
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2010
- Study completionJul 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.
- More trials run by Milton S. Hershey Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
- Investigators
- David T. Mauger, PhD, Principal investigator, Penn State College of MedicineStanley J. Szefler, MD, PhD, Principal investigator, National Jewish HealthRobert F. Lemanske, Jr., MD, Principal investigator, University of Wisconsin, MadisonRobert S. Zeiger, MD, PhD, Principal investigator, Kaiser Permanente Medical CenterRobert C. Strunk, MD, Principal investigator, Washington University School of MedicineFernando D. Martinez, MD, Principal investigator, University of Arizona College of MedicineLynn M. Taussig, MD, Study chair, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675584
- Sponsor's protocol ID
- 581
- Other IDs
- 5U10HL064313, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307
- Acronym
- MIST
- Status last verified
- May 2018
- First submitted
- 7 May 2008
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zeiger RS, Mauger D, Bacharier LB, Guilbert TW, Martinez FD, Lemanske RF Jr, Strunk RC, Covar R, Szefler SJ, Boehmer S, Jackson DJ, Sorkness CA, Gern JE, Kelly HW, Friedman NJ, Mellon MH, Schatz M, Morgan WJ, Chinchilli VM, Raissy HH, Bade E, Malka-Rais J, Beigelman A, Taussig LM; CARE Network of the National Heart, Lung, and Blood Institute. Daily or intermittent budesonide in preschool children with recurrent wheezing. N Engl J Med. 2011 Nov 24;365(21):1990-2001. doi: 10.1056/NEJMoa1104647.
PubMed 22111718
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Asthma Research and Education (CARE) Network Trial - Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
- ClinicalTrials.gov ID
- NCT00675584
- Acronym / sponsor ID
- MIST / 581
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Posted 1 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma affects about 4 million children in the United States and is a leading cause of hospitalizations and school absenteeism. Continuous wheezing in very young children may develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to treat children with particularly bad wheezing episodes. This study will compare the safety and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only during respiratory tract illnesses for toddlers with continuous wheezing or coughing illnesses.
Detailed description
Childhood asthma can be caused by many factors, including allergens, cigarette smoke, air pollution, or infections. Symptoms include wheezing, shortness of breath, chest tightness, and coughing. Wheezing illnesses are common during the first several years of life, and continuous wheezing, or recurrent intermittent wheezing, may be an indicator of asthma. Recurrent intermittent wheezing can also lead to breathing difficulties, sleep disturbances, and severe exacerbations that result in emergency department visits, hospitalizations, or even death. The Prevention of Early Asthma in Kids (PEAK) and Acute Intervention Management Strategies (AIMS) studies, both of which are part of the Childhood Asthma Research and Education (CARE) Network, as well as several other studies, have identified therapies that may improve recurrent wheezing in young children. This study will compare the safety and effectiveness of two treatment regimens-low doses of ICS taken on a daily basis versus higher doses of ICS taken only during respiratory tract illnesses-at improving recurrent wheezing in toddlers. Study researchers will also identify individual characteristics (e.g., age, gender, family history of asthma and allergies, the degree of allergy, genetics) that may be associated with treatment response. Lastly, the relationship of virus infections to respiratory illnesses, wheezing episodes, and response to study treatments will also be studied.
This study will enroll children between 12 and 53 months of age who have experienced episodes of wheezing or coughing in the year before study entry, with at least one episode that required one of the following: oral steroids, an urgent unscheduled medical visit, an emergency room visit, or hospitalization. This study will begin with a 2-week evaluation period during which potential participants will receive placebo once a day. Parents will document their child's asthma symptoms and medication use in a daily diary. Next, at a baseline study visit, eligible participants will be randomly assigned to one of the following two 12-month treatment groups:
- Group 1 participants will receive a low dose of ICS once a day at night, except during respiratory tract illnesses. During a respiratory tract illness, participants will receive placebo each morning and a low dose of ICS each night for 7 days.
- Group 2 participants will receive a high dose of ICS twice a day for 7 days during each respiratory illness and placebo once a day at night at all other times.
Throughout the 12 months of treatment, all participants will receive albuterol to treat respiratory symptoms and prednisolone if asthma symptoms worsen. Parents will be given an action plan to help manage their child's symptoms, and during respiratory illnesses, parents will contact study researchers to determine the best treatment plan. Study visits will occur at baseline and Weeks 4, 12, 20, 28, 36, 44, and 52. Participants' parents will take part in scheduled telephone interviews one month after each clinic visit to provide information on their child's asthma symptoms, study medication use, and health problems. Most study visits will include a physical exam and lung function testing. At select study visits, the following will occur: allergy skin testing, blood collection, nasal mucus sampling, and parent questionnaires to assess asthma, quality of life, and environmental factors. A portion of the participants' blood will undergo genetic analysis; a blood collection from parents for genetic analysis will be optional. Throughout the treatment period, participants' parents will record asthma symptoms and medication usage in a daily diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Budesonide | Active comparator | Drug: Budesonide, Drug: Placebo BudesonideParticipants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days. |
| Budesonide | Experimental | Drug: Budesonide, Drug: Placebo BudesonideParticipants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study. |
Who may qualify
- Ages
- 12 to 53 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participants who meet all of the following criteria are eligible for study entry. Participants may be reassessed if not initially eligible.
- Positive asthma predictive index (API) status
- A history of at least 4 wheezing episodes in the prior year with at least one physician diagnosed or at least 3 wheezing episodes in the prior year with at least one physician diagnosed and at least 3 months of asthma controller therapy in the prior year
- Experienced a severe exacerbation requiring systemic corticosteroids, urgent unscheduled or emergency visit, or hospitalization in the 12 months before the screening visit
- All immunizations must be completed, including varicella (unless the child has already had clinical varicella). If the child needs the varicella vaccine, this will be arranged with the primary care physician and must be received before study entry.
Key exclusion criteria (24 listed)
- Participants who meet any of the following criteria are NOT eligible for enrollment, but they may be re-enrolled if these exclusion criteria disappear:
- Use of more than six courses of systemic corticosteroids in the 12 months before the screening visit
- More than two hospitalizations for wheezing illnesses in the 12 months before the screening visit
- Use of oral or systemic corticosteroids in the 2 weeks before the screening visit
- Current treatment with antibiotics for diagnosed sinus disease
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 |
|---|---|---|
| BudesonideAlso: Pulmicort Respules®Participants in Arm 1 will receive 0.5 mg of budesonide once a day. Participants in Arm 2 will receive 1 mg of budesonide twice a day for 7 days at the onset of respiratory tract illnesses. | Drug | Budesonide, Placebo Budesonide |
| Placebo BudesonideAlso: Placebo Pulmicort Respules®Participants in Arm 1 will receive placebo budesonide each morning during respiratory tract illnesses for 7 days. Participants in Arm 2 will receive placebo budesonide once a day for the entire study, other than when they have a respiratory tract illness. | Drug | Budesonide, Placebo Budesonide |
Primary outcome
Rate of Exacerbations Requiring Systemic Corticosteroids
Time frame: Measured during the 12-month follow-up period
The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up
10 secondary outcomes
Proportion of Episode-free Days
Time frame: Measured during the 12-month follow-up period
Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months
Time frame: Measured during the 12-month follow-up period
Number of Participants With Treatment Failure
Time frame: Measured during the 12-month follow-up period
Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO)
Time frame: baseline and 12 months
Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry
Time frame: baseline and 12 months
Adverse Events Associated With Corticosteroid Use
Time frame: Measured during the 12-month follow-up period
Number of Days of Absence From Daycare and Preschool for the Child and From Work for the Caregiver Per 12 Months
Time frame: Measured during the 12-month follow-up period
Proportion of Days With Rescue Albuterol Use
Time frame: Measured during the 12-month follow-up period
Change in Wheeze Severity During a Respiratory Tract Illness
Time frame: Measured during the first seven days for each respiratory tract illness
Change Between 12 Months and Baseline in the Caregiver Quality-of-life
Time frame: baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22111718Zeiger RS, Mauger D, Bacharier LB, Guilbert TW, Martinez FD, Lemanske RF Jr, Strunk RC, Covar R, Szefler SJ, Boehmer S, Jackson DJ, Sorkness CA, Gern JE, Kelly HW, Friedman NJ, Mellon MH, Schatz M, Morgan WJ, Chinchilli VM, Raissy HH, Bade E, Malka-Rais J, Beigelman A, Taussig LM; CARE Network of the National Heart, Lung, and Blood Institute. Daily or intermittent budesonide in preschool children with recurrent wheezing. N Engl J Med. 2011 Nov 24;365(21):1990-2001. doi: 10.1056/NEJMoa1104647.
- Click here for the Childhood Asthma Research and Education (CARE) Network Web siteLink provided by the sponsor.
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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.
David T. Mauger, PhD principal investigator
Penn State College of Medicine
Stanley J. Szefler, MD, PhD principal investigator
National Jewish Health
Robert F. Lemanske, Jr., MD principal investigator
University of Wisconsin, Madison
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Asthma, run by Milton S. Hershey Medical Center at 5 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 7 inclusion and 24 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 1 Jun 2012). 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?
Rate of Exacerbations Requiring Systemic Corticosteroids (time frame: Measured during the 12-month follow-up period). 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 NCT00675584, 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 26 Jun 2018.