AsthmaAFFIRMNCT00459368
Using Information Technology to Improve Asthma Adherence
A study testing Feedback of patient adherence information in people with Asthma and Patient Compliance, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control. Read more about this study
- Who is it for?
- Ages 5 to 56 years
- Conditions the study is for
- Asthma, Patient Compliance
- What is being tested?
- Feedback of patient adherence information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,698 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2009
- 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 5 to 56 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 5-56 years
- Physician diagnosis of asthma
- Continuous HMO enrollment with prescription drug rider
- Electronic prescription of an inhaled corticosteroid
- Primary care practice (i.e., pediatrics, family practice, or internal medicine) within the health system. A practice is defined as a group of physicians who by virtue of speciality or geography care for a relatively contained population of patients and who cross-cover the care of these patients.
Who cannot join
- Diagnosis of chronic obstructive pulmonary disease
- Diagnosis of congestive heart failure
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence Feedback for Improving Respiratory Medication Use
The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.
Read the detailed description
In 2001 an estimated 31.1 million people in the United States reported ever having had an asthma diagnosis. Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly.
The routine use of anti-inflammatory medications, particularly inhaled corticosteroids (ICS), in the treatment of asthma can markedly improve symptoms and reduce complications. Yet, evidence suggests that these medications are under-prescribed by physicians and poorly taken by patients. For example, in one study of asthma patients enrolled in a large, California HMO only 71.7% of patients with severe symptoms reported having a steroid inhaler, and only 53.6% of those reported using it daily in the preceding month. Using electronic monitoring devices to record inhaler use, researchers have estimated that patients use their ICS as directed 20 to 73% of the time. Using claims-based measures of adherence we have shown that adherence to inhaled steroids is inversely correlated with the frequency of oral steroid use and asthma-related emergency room visits. In addition, these measures suggest that non-adherence to ICS is an independent predictor of asthma-related hospitalizations. In our study population, we estimated that 60% of asthma-related hospitalizations were attributable to poor adherence to ICS. Together these findings suggest that increasing ICS use may improve asthma outcomes.
Studies employing health-behavioral models of adherence suggest that medication adherence is associated with treatment-related concerns regarding complications, efficacy, and benefits. Unfortunately, the results of behavioral and educational interventions to improve adherence have been disappointing. Despite, in some cases, considerable time spent with patients, these interventions have at best resulted in modest adherence improvements. Given the time, training, and resources required to implement these interventions, they are unlikely to be widely adopted in the clinical setting. Some recent studies, however, suggest that providing adherence data to clinicians may improve patient adherence. In one, clinicians gave repeated feedback to patients regarding ICS adherence; this resulted in sustained improvements over the study period. Unfortunately, this small study did not find differences in asthma outcomes.
In this proposal we seek to test an asthma adherence intervention specifically designed for use in the clinical setting. Adherence measures will be generated by linking currently available electronic data. In this cluster-randomized trial, primary care physician-practice groups will be randomized to receive asthma medication adherence information electronically for patients with asthma associated with these practices. In addition to ICS adherence information, clinicians in intervention practices will have data on patient beta-agonist use to better tailor ICS therapy to disease severity.
Eligible patients with asthma will be identified prior to randomizing practices and will be invited to participate. Patient surveys will be sent in the pre-intervention survey and in the post-intervention period. Patient-level outcomes will be assessed through the medical record, patient surveys, and claims data.
We will perform an intention-to-treat analysis with all eligible patients identified pre-randomization included in the analysis (the primary analysis). This study is powered to allow for only 60% of the eligible patient population being seen within the first 6-months (i.e., no effect in 40% of the patient population). As a secondary analysis, we will perform a modified intention-to-treat (or per protocol) analysis, whereby we will analyze the results of only those patients in both study arms seen within the first 6-months of the intervention.
- Conditions
- Asthma, Patient Compliance
- Being tested
- Feedback of patient adherence information, Active control group
- Keywords
- asthma, patient compliance, metered dose inhalers, corticosteroids, health behaviour, prevention & control
- Medical subject headings
- Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback of patient adherence informationBehavioural
Also called Adherence feedback
Patient inhaled corticosteroid adherence information is being provided to physicians at clinic sites randomized to the intervention arm. Adherence information is available via electronic prescribing software, and so is available to physicians when writing, renewing, or viewing medications. Physicians at intervention sites also receive standard training in how to interpret adherence metrics and how to intervene on poor adherence.
Active control groupBehavioural
Also called Standard care
Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified. Receives: Behavioral: Feedback of patient adherence information |
| II | Active comparator | Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software. Receives: Behavioral: Active control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Adherence to Inhaled Corticosteroids (ICS)
Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.
Measured: 1 year
Secondary outcomes (7)
Asthma-related Emergency Room Visits
Measured: 1 year
Asthma-related Hospitalizations
Measured: 1 year
Oral Steroid Use
Measured: 1 year
Patient Self-efficacy to ICS Treatment
Measured: survey following intervention period
Readiness to Improve ICS Adherence (Transtheoretical Model)
Measured: survey following intervention period
Patient-physician Communication (Patient Reported Measure)
Measured: survey following intervention period
Patient Medical Care Costs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionNov 2009
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 (17)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- L. Keoki Williams, MD, MPH, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459368
- Sponsor's protocol ID
- R01HL079055
- Acronym
- AFFIRM
- Status last verified
- Jun 2010
- First submitted
- 9 Apr 2007
- Last updated
- 17 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Centers for Disease Control and Prevention (CDC). Self-reported asthma prevalence and control among adults--United States, 2001. MMWR Morb Mortal Wkly Rep. 2003 May 2;52(17):381-4.
PubMed 12765201Legorreta AP, Christian-Herman J, O'Connor RD, Hasan MM, Evans R, Leung KM. Compliance with national asthma management guidelines and specialty care: a health maintenance organization experience. Arch Intern Med. 1998 Mar 9;158(5):457-64. doi: 10.1001/archinte.158.5.457.
PubMed 9508223Cochrane MG, Bala MV, Downs KE, Mauskopf J, Ben-Joseph RH. Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique. Chest. 2000 Feb;117(2):542-50. doi: 10.1378/chest.117.2.542.
PubMed 10669701Williams LK, Pladevall M, Xi H, Peterson EL, Joseph C, Lafata JE, Ownby DR, Johnson CC. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol. 2004 Dec;114(6):1288-93. doi: 10.1016/j.jaci.2004.09.028.
PubMed 15577825Apter AJ, Boston RC, George M, Norfleet AL, Tenhave T, Coyne JC, Birck K, Reisine ST, Cucchiara AJ, Feldman HI. Modifiable barriers to adherence to inhaled steroids among adults with asthma: it's not just black and white. J Allergy Clin Immunol. 2003 Jun;111(6):1219-26. doi: 10.1067/mai.2003.1479.
PubMed 12789220Schmaling KB, Afari N, Blume AW. Assessment of psychological factors associated with adherence to medication regimens among adult patients with asthma. J Asthma. 2000 Jun;37(4):335-43. doi: 10.3109/02770900009055457.
PubMed 10883744Leickly FE, Wade SL, Crain E, Kruszon-Moran D, Wright EC, Evans R 3rd. Self-reported adherence, management behavior, and barriers to care after an emergency department visit by inner city children with asthma. Pediatrics. 1998 May;101(5):E8. doi: 10.1542/peds.101.5.e8.
PubMed 9565441Bender B, Milgrom H, Apter A. Adherence intervention research: what have we learned and what do we do next? J Allergy Clin Immunol. 2003 Sep;112(3):489-94. doi: 10.1016/s0091-6749(03)01718-4.
PubMed 13679805McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. doi: 10.1001/jama.288.22.2868.
PubMed 12472329Schectman JM, Schorling JB, Nadkarni MM, Voss JD. Can prescription refill feedback to physicians improve patient adherence? Am J Med Sci. 2004 Jan;327(1):19-24. doi: 10.1097/00000441-200401000-00005.
PubMed 14722392Onyirimba F, Apter A, Reisine S, Litt M, McCusker C, Connors M, ZuWallack R. Direct clinician-to-patient feedback discussion of inhaled steroid use: its effect on adherence. Ann Allergy Asthma Immunol. 2003 Apr;90(4):411-5. doi: 10.1016/S1081-1206(10)61825-X.
PubMed 12722963Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health. 2004 Mar;94(3):416-22. doi: 10.2105/ajph.94.3.416.
PubMed 14998805Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available.
PubMed 15031246Ahmedani BK, Peterson EL, Wells KE, Williams LK. Examining the relationship between depression and asthma exacerbations in a prospective follow-up study. Psychosom Med. 2013 Apr;75(3):305-10. doi: 10.1097/PSY.0b013e3182864ee3. Epub 2013 Feb 25.
PubMed 23440228Ahmedani BK, Peterson EL, Wells KE, Rand CS, Williams LK. Asthma medication adherence: the role of God and other health locus of control factors. Ann Allergy Asthma Immunol. 2013 Feb;110(2):75-9.e2. doi: 10.1016/j.anai.2012.11.006. Epub 2012 Dec 7.
PubMed 23352524
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Feedback for Improving Respiratory Medication Use
- ClinicalTrials.gov ID
- NCT00459368
- Acronym / sponsor ID
- AFFIRM / R01HL079055
- Conditions
- Asthma, Patient Compliance
- Keywords
- asthma, patient compliance, metered dose inhalers, corticosteroids, health behaviour, prevention & control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,698 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Posted 10 Aug 2010
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 study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.
Detailed description
In 2001 an estimated 31.1 million people in the United States reported ever having had an asthma diagnosis. Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly.
The routine use of anti-inflammatory medications, particularly inhaled corticosteroids (ICS), in the treatment of asthma can markedly improve symptoms and reduce complications. Yet, evidence suggests that these medications are under-prescribed by physicians and poorly taken by patients. For example, in one study of asthma patients enrolled in a large, California HMO only 71.7% of patients with severe symptoms reported having a steroid inhaler, and only 53.6% of those reported using it daily in the preceding month. Using electronic monitoring devices to record inhaler use, researchers have estimated that patients use their ICS as directed 20 to 73% of the time. Using claims-based measures of adherence we have shown that adherence to inhaled steroids is inversely correlated with the frequency of oral steroid use and asthma-related emergency room visits. In addition, these measures suggest that non-adherence to ICS is an independent predictor of asthma-related hospitalizations. In our study population, we estimated that 60% of asthma-related hospitalizations were attributable to poor adherence to ICS. Together these findings suggest that increasing ICS use may improve asthma outcomes.
Studies employing health-behavioral models of adherence suggest that medication adherence is associated with treatment-related concerns regarding complications, efficacy, and benefits. Unfortunately, the results of behavioral and educational interventions to improve adherence have been disappointing. Despite, in some cases, considerable time spent with patients, these interventions have at best resulted in modest adherence improvements. Given the time, training, and resources required to implement these interventions, they are unlikely to be widely adopted in the clinical setting. Some recent studies, however, suggest that providing adherence data to clinicians may improve patient adherence. In one, clinicians gave repeated feedback to patients regarding ICS adherence; this resulted in sustained improvements over the study period. Unfortunately, this small study did not find differences in asthma outcomes.
In this proposal we seek to test an asthma adherence intervention specifically designed for use in the clinical setting. Adherence measures will be generated by linking currently available electronic data. In this cluster-randomized trial, primary care physician-practice groups will be randomized to receive asthma medication adherence information electronically for patients with asthma associated with these practices. In addition to ICS adherence information, clinicians in intervention practices will have data on patient beta-agonist use to better tailor ICS therapy to disease severity.
Eligible patients with asthma will be identified prior to randomizing practices and will be invited to participate. Patient surveys will be sent in the pre-intervention survey and in the post-intervention period. Patient-level outcomes will be assessed through the medical record, patient surveys, and claims data.
We will perform an intention-to-treat analysis with all eligible patients identified pre-randomization included in the analysis (the primary analysis). This study is powered to allow for only 60% of the eligible patient population being seen within the first 6-months (i.e., no effect in 40% of the patient population). As a secondary analysis, we will perform a modified intention-to-treat (or per protocol) analysis, whereby we will analyze the results of only those patients in both study arms seen within the first 6-months of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: Feedback of patient adherence informationIn this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified. |
| II | Active comparator | Behavioral: Active control groupPhysician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software. |
Who may qualify
- Ages
- 5 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 5-56 years
- Physician diagnosis of asthma
- Continuous HMO enrollment with prescription drug rider
- Electronic prescription of an inhaled corticosteroid
- Primary care practice (i.e., pediatrics, family practice, or internal medicine) within the health system. A practice is defined as a group of physicians who by virtue of speciality or geography care for a relatively contained population of patients and who cross-cover the care of these patients.
Key exclusion criteria (3 listed)
- Diagnosis of chronic obstructive pulmonary disease
- Diagnosis of congestive heart failure
- None
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 |
|---|---|---|
| Feedback of patient adherence informationAlso: Adherence feedbackPatient inhaled corticosteroid adherence information is being provided to physicians at clinic sites randomized to the intervention arm. Adherence information is available via electronic prescribing software, and so is available to physicians when writing, renewing, or viewing medications. Physicians at intervention sites also receive standard training in how to interpret adherence metrics and how to intervene on poor adherence. | Behavioural | I |
| Active control groupAlso: Standard carePhysician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software. | Behavioural | II |
Primary outcome
Patient Adherence to Inhaled Corticosteroids (ICS)
Time frame: 1 year
Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.
7 secondary outcomes
Asthma-related Emergency Room Visits
Time frame: 1 year
Asthma-related Hospitalizations
Time frame: 1 year
Oral Steroid Use
Time frame: 1 year
Patient Self-efficacy to ICS Treatment
Time frame: survey following intervention period
Readiness to Improve ICS Adherence (Transtheoretical Model)
Time frame: survey following intervention period
Patient-physician Communication (Patient Reported Measure)
Time frame: survey following intervention period
Patient Medical Care Costs
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12765201Centers for Disease Control and Prevention (CDC). Self-reported asthma prevalence and control among adults--United States, 2001. MMWR Morb Mortal Wkly Rep. 2003 May 2;52(17):381-4.
- Background: PubMed 9508223Legorreta AP, Christian-Herman J, O'Connor RD, Hasan MM, Evans R, Leung KM. Compliance with national asthma management guidelines and specialty care: a health maintenance organization experience. Arch Intern Med. 1998 Mar 9;158(5):457-64. doi: 10.1001/archinte.158.5.457.
- Background: PubMed 10669701Cochrane MG, Bala MV, Downs KE, Mauskopf J, Ben-Joseph RH. Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique. Chest. 2000 Feb;117(2):542-50. doi: 10.1378/chest.117.2.542.
- Background: PubMed 15577825Williams LK, Pladevall M, Xi H, Peterson EL, Joseph C, Lafata JE, Ownby DR, Johnson CC. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol. 2004 Dec;114(6):1288-93. doi: 10.1016/j.jaci.2004.09.028.
- Background: PubMed 12789220Apter AJ, Boston RC, George M, Norfleet AL, Tenhave T, Coyne JC, Birck K, Reisine ST, Cucchiara AJ, Feldman HI. Modifiable barriers to adherence to inhaled steroids among adults with asthma: it's not just black and white. J Allergy Clin Immunol. 2003 Jun;111(6):1219-26. doi: 10.1067/mai.2003.1479.
- Background: PubMed 10883744Schmaling KB, Afari N, Blume AW. Assessment of psychological factors associated with adherence to medication regimens among adult patients with asthma. J Asthma. 2000 Jun;37(4):335-43. doi: 10.3109/02770900009055457.
- Background: PubMed 9565441Leickly FE, Wade SL, Crain E, Kruszon-Moran D, Wright EC, Evans R 3rd. Self-reported adherence, management behavior, and barriers to care after an emergency department visit by inner city children with asthma. Pediatrics. 1998 May;101(5):E8. doi: 10.1542/peds.101.5.e8.
- Background: PubMed 13679805Bender B, Milgrom H, Apter A. Adherence intervention research: what have we learned and what do we do next? J Allergy Clin Immunol. 2003 Sep;112(3):489-94. doi: 10.1016/s0091-6749(03)01718-4.
- Background: PubMed 12472329McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. doi: 10.1001/jama.288.22.2868.
- Background: PubMed 14722392Schectman JM, Schorling JB, Nadkarni MM, Voss JD. Can prescription refill feedback to physicians improve patient adherence? Am J Med Sci. 2004 Jan;327(1):19-24. doi: 10.1097/00000441-200401000-00005.
- Background: PubMed 12722963Onyirimba F, Apter A, Reisine S, Litt M, McCusker C, Connors M, ZuWallack R. Direct clinician-to-patient feedback discussion of inhaled steroid use: its effect on adherence. Ann Allergy Asthma Immunol. 2003 Apr;90(4):411-5. doi: 10.1016/S1081-1206(10)61825-X.
- Background: PubMed 14998805Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health. 2004 Mar;94(3):416-22. doi: 10.2105/ajph.94.3.416.
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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.
L. Keoki Williams, MD, MPH principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback of patient adherence information in people with Asthma and Patient Compliance, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 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 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2010). 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?
Patient Adherence to Inhaled Corticosteroids (ICS) (time frame: 1 year). 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 NCT00459368, which also lists 17 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 17 Aug 2010; AzTrials last refreshed its copy on 29 Oct 2026.