AsthmaAIMSNCT00319488
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
A study testing Inhaled Corticosteroid (Budesonide), Leukotriene Receptor Antagonist (Montelukast Sodium) and Inhaled Albuterol in people with Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 6 sites in United States.
Trial summary
This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing episode-free days among young children… Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Asthma, Lung Diseases
- What is being tested?
- Inhaled Corticosteroid (Budesonide), Leukotriene Receptor Antagonist (Montelukast Sodium) and Inhaled Albuterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2004to Nov 2006
- Phase
- Interventional
- 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 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Recurrent episodes (at least two) of wheezing in the context of a RTI, at least one of which must be documented by a health care provider (parental report) over the 12 months prior to study entry, and of which one episode must have occurred within 6 months prior to study entry
- Either two episodes of '1,' OR two episodes of '2,' OR one episode of '1' AND one episode of '2,' defined by the following:
- Urgent care visit for acute wheezing (emergency department, urgent care center, or unscheduled primary care physician office visit), which required treatment with a bronchodilator, within 12 months prior to study entry
- Episode of wheezing within 12 months prior to study entry, which required treatment with oral corticosteroids not associated with a visit to a health care provider, urgent care center, emergency department, or hospital
- Immunizations are up to date, including varicella (unless the patient has already had clinical varicella)
- Willingness to provide informed consent by patient's parent or guardian
Who cannot join
- Use of more than six courses of systemic corticosteroids during the 12 months prior to study entry
- More than two hospitalizations for wheezing illnesses within 12 months prior to study entry
- Use of long-term controller medications for asthma (including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline) for 4 or more months (cumulative use) within 1 year prior to study entry
- Any use of long-term controller medications for asthma (including corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) within the 2 weeks prior to the enrollment visit
- Current treatment with antibiotics for diagnosed sinus disease
- Contraindication of use of systemic corticosteroids
Show all 22Show fewer
- Prematurity (defined as birth before 36 weeks gestational age)
- Presence of lung disease other than asthma (e.g., cystic fibrosis and BPD)
- Presence of other significant medical illnesses (e.g., cardiac, liver, gastrointestinal, or endocrine disease) that would place the patient at increased risk
- Gastroesophageal reflux under medical therapy
- Immunodeficiency disorders
- History of respiratory failure requiring mechanical ventilation
- History of hypoxic seizure
- Inability to cooperate with nebulization therapy
- Inability to ingest the study drugs
- History of significant adverse reaction to any study medication ingredient
- Current participation, or participation in the month prior to study entry, in another investigational drug study
- Evidence that the family may be unreliable, nonadherent, or likely to move from the clinical center area before study completion
- Persistent symptomatic asthma, as defined as experiencing symptoms (i.e., nocturnal cough, daytime cough, wheezing, difficulty breathing, or symptoms interfering with activities) and/or requiring albuterol use on average 4 or more days per week in the 2-week observation period prior to the randomization visit
- The following scores, based on a 5-point scale with 5 representing very severe symptoms (measured at randomization visit): score equal to or greater than one for albuterol use, wheezing, difficulty breathing, nighttime cough, and asthma symptoms interfering with activities; score greater than 2 for daytime cough on an average of 4 or more days/week during the 2-week observation period
- Failure to complete diary cards at expected levels (at least 80% of days) during the observation period
- Use of long-term controller medications for asthma (e.g., corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) during the 2-week observation period
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
National Jewish Medical and Research Center
Denver, Colorado, 80206
Dept. of Health Evaluation Sciences, Penn State College of Medicine
Hershey, Pennsylvania, 17033
UCSD School of Medicine
La Jolla, California, 92093
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Washington University School of Medicine Patient Oriented Research Unit
St Louis, Missouri, 63110
University of Arizona, College of Medicine
Tucson, Arizona, 85724
About this study
This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing episode-free days among young children with recurrent severe wheezing.
Read the detailed description
Acute Intervention Management Strategies (AIMS) is a randomized, double-blind, double-dummy, placebo-controlled parallel comparison study that will compare the effectiveness of three treatments, when given at the onset of RTI-associated symptoms, in increasing the proportion of symptom-free days over the entire treatment period of the 5- to 9-month study. There will be a 2-week period to qualify and characterize participants, who at that time will have no lower respiratory tract symptoms other than mild cough. A total of 244 participants will be randomized to one of three treatment groups and followed for the remainder of the fall-winter-early spring season. Participants will receive one of the following treatment regimens for 7 days, at the first sign of RTI-associated symptoms: 1) active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily; 2) active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily; or 3) placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily.
- Conditions
- Asthma, Lung Diseases
- Being tested
- Inhaled Corticosteroid (Budesonide), Leukotriene Receptor Antagonist (Montelukast Sodium), Inhaled Albuterol
- Keywords
- Wheezing, Respiratory Tract Illness
- Medical subject headings
- Asthma, Lung Diseases, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Corticosteroid (Budesonide)Drug
Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms.
Leukotriene Receptor Antagonist (Montelukast Sodium)Drug
Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms.
Inhaled AlbuterolDrug
All participants will receive inhaled albuterol treatments four times a day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily Receives: Drug: Inhaled Corticosteroid (Budesonide); Drug: Inhaled Albuterol |
| 2 | Active comparator | Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily Receives: Drug: Leukotriene Receptor Antagonist (Montelukast Sodium); Drug: Inhaled Albuterol |
| 3 | Placebo comparator | Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily Receives: Drug: Inhaled Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of episode-free days as determined by diary cards
Measured: Measured over 12-month follow-up period
Secondary outcomes (8)
Time to initiation of first course of oral corticosteroids
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Total number of courses of oral corticosteroids
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Duration and severity of lower respiratory tract symptoms
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Number of wheezing episodes
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Time to treatment failure
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Measures of patient and family morbidity
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Number of unscheduled visits for acute wheezing episodes
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Linear growth
Measured: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startFeb 2004
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Vernon M. Chinchilli, PhD, Principal investigator, Pennsylvania State University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319488
- Sponsor's protocol ID
- 386
- Other IDs
- 5U10HL064313-07, 5U10HL064287, 5U10HL064307, 5U10HL064305, 5U10HL064288, 5U10HL064295
- Acronym
- AIMS
- Status last verified
- Apr 2012
- First submitted
- 27 Apr 2006
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bacharier LB, Phillips BR, Zeiger RS, Szefler SJ, Martinez FD, Lemanske RF Jr, Sorkness CA, Bloomberg GR, Morgan WJ, Paul IM, Guilbert T, Krawiec M, Covar R, Larsen G, Mellon M, Moss MH, Chinchilli VM, Taussig LM, Strunk RC; CARE Network. Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing. J Allergy Clin Immunol. 2008 Dec;122(6):1127-1135.e8. doi: 10.1016/j.jaci.2008.09.029. Epub 2008 Oct 30.
PubMed 18973936Fitzpatrick AM, Grunwell JR, Cottrill KA, Mutic AD, Mauger DT. Blood Eosinophils for Prediction of Exacerbation in Preschool Children With Recurrent Wheezing. J Allergy Clin Immunol Pract. 2023 May;11(5):1485-1493.e8. doi: 10.1016/j.jaip.2023.01.037. Epub 2023 Feb 3.
PubMed 36738927
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
- ClinicalTrials.gov ID
- NCT00319488
- Acronym / sponsor ID
- AIMS / 386
- Conditions
- Asthma, Lung Diseases
- Keywords
- Wheezing, Respiratory Tract Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Feb 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 27 Apr 2006 (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.
This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing episode-free days among young children with recurrent severe wheezing.
Detailed description
Acute Intervention Management Strategies (AIMS) is a randomized, double-blind, double-dummy, placebo-controlled parallel comparison study that will compare the effectiveness of three treatments, when given at the onset of RTI-associated symptoms, in increasing the proportion of symptom-free days over the entire treatment period of the 5- to 9-month study. There will be a 2-week period to qualify and characterize participants, who at that time will have no lower respiratory tract symptoms other than mild cough. A total of 244 participants will be randomized to one of three treatment groups and followed for the remainder of the fall-winter-early spring season. Participants will receive one of the following treatment regimens for 7 days, at the first sign of RTI-associated symptoms: 1) active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily; 2) active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily; or 3) placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Inhaled Corticosteroid (Budesonide), Drug: Inhaled AlbuterolActive ICS plus placebo LTRA plus albuterol inhalation treatments four times daily |
| 2 | Active comparator | Drug: Leukotriene Receptor Antagonist (Montelukast Sodium), Drug: Inhaled AlbuterolActive LTRA plus placebo ICS plus albuterol inhalation treatment four times daily |
| 3 | Placebo comparator | Drug: Inhaled AlbuterolPlacebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Recurrent episodes (at least two) of wheezing in the context of a RTI, at least one of which must be documented by a health care provider (parental report) over the 12 months prior to study entry, and of which one episode must have occurred within 6 months prior to study entry
- Either two episodes of '1,' OR two episodes of '2,' OR one episode of '1' AND one episode of '2,' defined by the following:
- Immunizations are up to date, including varicella (unless the patient has already had clinical varicella)
- Willingness to provide informed consent by patient's parent or guardian
Key exclusion criteria (22 listed)
- Use of more than six courses of systemic corticosteroids during the 12 months prior to study entry
- More than two hospitalizations for wheezing illnesses within 12 months prior to study entry
- Use of long-term controller medications for asthma (including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline) for 4 or more months (cumulative use) within 1 year prior to study entry
- Any use of long-term controller medications for asthma (including corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) within the 2 weeks prior to the enrollment 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 |
|---|---|---|
| Inhaled Corticosteroid (Budesonide)Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms. | Drug | 1 |
| Leukotriene Receptor Antagonist (Montelukast Sodium)Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms. | Drug | 2 |
| Inhaled AlbuterolAll participants will receive inhaled albuterol treatments four times a day. | Drug | 1, 2, 3 |
Primary outcome
Proportion of episode-free days as determined by diary cards
Time frame: Measured over 12-month follow-up period
8 secondary outcomes
Time to initiation of first course of oral corticosteroids
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Total number of courses of oral corticosteroids
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Duration and severity of lower respiratory tract symptoms
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Number of wheezing episodes
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Time to treatment failure
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Measures of patient and family morbidity
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Number of unscheduled visits for acute wheezing episodes
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Linear growth
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
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 29 Jul 2016.
- Results publication: PubMed 18973936Bacharier LB, Phillips BR, Zeiger RS, Szefler SJ, Martinez FD, Lemanske RF Jr, Sorkness CA, Bloomberg GR, Morgan WJ, Paul IM, Guilbert T, Krawiec M, Covar R, Larsen G, Mellon M, Moss MH, Chinchilli VM, Taussig LM, Strunk RC; CARE Network. Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing. J Allergy Clin Immunol. 2008 Dec;122(6):1127-1135.e8. doi: 10.1016/j.jaci.2008.09.029. Epub 2008 Oct 30.
- Derived from this study: PubMed 36738927Fitzpatrick AM, Grunwell JR, Cottrill KA, Mutic AD, Mauger DT. Blood Eosinophils for Prediction of Exacerbation in Preschool Children With Recurrent Wheezing. J Allergy Clin Immunol Pract. 2023 May;11(5):1485-1493.e8. doi: 10.1016/j.jaip.2023.01.037. Epub 2023 Feb 3.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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.
Vernon M. Chinchilli, PhD principal investigator
Pennsylvania State University, College of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled Corticosteroid (Budesonide), Leukotriene Receptor Antagonist (Montelukast Sodium) and Inhaled Albuterol in people with Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 6 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 6 inclusion and 22 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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
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?
Proportion of episode-free days as determined by diary cards (time frame: Measured over 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 NCT00319488, which also lists 2 linked publications.
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 29 Jul 2016.