AsthmaNCT03248869
Asthma Mobile Health Application 2.0
A study testing Current Daily Survey and Mobile Health App in people with Asthma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Current Daily Survey and Mobile Health App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,752 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2015to 15 Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Self-reported physician diagnosed asthma
- Have an iPhone
- Sufficient English-language ability to participate in informed consent process, complete study assessments and understand the text in mobile phone-delivered interventions
Who cannot join
- <18 years of age
- Not currently taking any asthma medications
- Does not own an iPhone or know how to handle a mobile phone
- Are unable to read or understand the study materials
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. of Genetics and Genomic Sciences, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU).
Read the detailed description
Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU).
During the AMHA 2.0 study, the aims are to evaluate the feasibility of:
- Consenting and enrolling a small cohort of subjects with asthma recruited from Mount Sinai pulmonary clinics remotely via downloading the app
- Feasibility of use of an asthma e-diary and automated e-reminders for medications in this small cohort for one month
- Exploring if a small cohort of participants will share data from wearable health and fitness monitoring devices if they own and use such devices.
The primary enrollment period for AMHA 2.0 was met in September 2015. More than 7,000 individuals e-consented for the AMHA 2.0 study, providing more than 80,000 survey responses with many participants granting AMHA 2.0 investigators access to geo-location and wellness data. Data collected during the first six months of the AMHA 2.0 study has provided evidence to answer all primary outcome measures.
Continuation of the AMHA 2.0 protocol was approved in December 2015, expanding the study to a larger population who will be followed for a more extended period of time and will be recruited via availability of the AMHA in the Apple App Store in the US, UK, and Ireland. The latest modification submitted in January, adds an entirely new aim, OM6 and SA6, to the project to include a genetics module. The objectives for the continuation study are:
- To determine the feasibility of recruiting, consenting and enrolling a larger number of subjects remotely via the Apple App Store without direct participant contact during any phase of the study
- Assess the impact of continued use of an asthma e-diary and automated medication e-reminders for up to 2 years
- Explore the feasibility of sharing of data from wearable health and fitness monitoring devices (if applicable) from a larger cohort of patients for up to 2 years
- To test the medical accuracy of algorithms that may be used in future app versions to give specific feedback to participants based on information they input into the AMHA
- To investigate the association between DNA variants and asthma phenotypes including: asthma severity, symptom patterns, and medication use/response
This second phase of research is designed to continue the process of developing an AMHA that facilitates asthma self-monitoring, promotes positive behavioral changes, and reinforces adherence to treatment plans according to current asthma guidelines, all in a user-friendly fashion conducive to long term use.
- Conditions
- Asthma
- Being tested
- Current Daily Survey, Mobile Health App
- Keywords
- asthma, mobile application, mobile app, mobile health applications, asthma mobile health application
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current Daily SurveyOther
need description
Mobile Health AppOther
Also called Asthma Mobile Health App
Participants recruited, consented and enrolled via the AMHA and complete assessments using the app
| Study group | Role | What they receive |
|---|---|---|
| Current Daily Survey | Active comparator | need description Receives: Other: Current Daily Survey |
| Mobile Health App (MHA) | Experimental | Participants download the mobile health app via the Apple App Store Receives: Other: Mobile Health App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of downloads
Number of people who downloaded AMHA
Measured: 2 years
Percent of participants who aborted study participation
Percent of aborted study participants before completion inclusion/exclusion criteria
Measured: 2 years
Secondary outcomes (13)
Frequency of use of the Daily asthma diary
Feasibility and implied participant acceptability by counting frequency of use of app
Measured: 2 years
Frequency of use of the Asthma Control (AC) questionnaire
Feasibility and implied participant acceptability by counting frequency of use of app
Measured: 2 years
Frequency of use of the Health Care Utilization (HCU) questionnaire
Feasibility and implied participant acceptability by counting frequency of use of app
Measured: 2 years
Percent of completion of Daily asthma diary
Feasibility and implied participant acceptability by counting percent of completion of features in AMHA
Measured: 2 years
Percent of completion of the Asthma Control (AC) questionnaire
Feasibility and implied participant acceptability by counting percent of completion of features in AMHA
Measured: 2 years
Percent of completion of the Health Care Utilization (HCU) questionnaire
Feasibility and implied participant acceptability by counting percent of completion of features in AMHA
Measured: 2 years
Frequency of use of optional AMHA features
Feasibility and implied participant acceptability by frequency of use of optional AMHA features
Measured: 2 years
Asthma Control (AC) questionnaire
Daily asthma diary to track asthma control. AC is based o modified GOAL criteria. Total scale range is from 0 (no impairment) 6 (maximal impairment for symptoms and rescue use)
Measured: up to 6 months
EuroQol 5D-5L (EQ-5D-5L)
EuroQol 5D-5L used to measure quality of life: 5 items are scored from 1 (no problems) to 5 (extreme severe problems). The numerals 1-5 have no arithmetic properties and should not be used as a cardinal scale. total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 55555 indicates severe problems in each item.
Measured: up to 6 months
Health Care Utilization (HCU) score
Questionnaire regarding HCU events with scores from 0 (no health services used to 10 (all health care service options utilized).
Measured: up to 6 months
Associations between genetic markers and asthma severity
Statistically significant associations between DNA variants and asthma severity. Clustering, regression, and ensemble statistical models will be employed to partition AMHA 2.0 participants into distinct phenotypic classes.
Measured: 2 years
Associations between genetic markers and symptom patterns
Statistically significant associations between DNA variants and symptom patterns. Clustering, regression, and ensemble statistical models will be employed to partition AMHA 2.0 participants into distinct phenotypic classes.
Measured: 2 years
Associations between genetic markers and medication use/response
Statistically significant associations between DNA variants and medication use/response. Clustering, regression, and ensemble statistical models will be employed to partition AMHA 2.0 participants into distinct phenotypic classes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start15 Mar 2015
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A/B testing is a randomized statistical experiment with intervention and control study arms, A and B. New users, as of December 2015, will be stratified and randomized to different daily survey formats in order to test differences in daily survey participation rates. Since this was a mobile "app" based study, a first of its kind - which was available in the App store, it was possible to recruit widely in large numbers. Therefore, even though this was a feasibility study, the sample size was large.
- Masking
- None (open label)
- Enrolment
- 7,752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Apple Inc., Lifemap Solutions, Inc, Sage Bionetworks
- Responsible party
- Sponsor
- Investigators
- Yu-feng Y Chan, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248869
- Sponsor's protocol ID
- GCO 15-0063
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murphy KR, Meltzer EO, Blaiss MS, Nathan RA, Stoloff SW, Doherty DE. Asthma management and control in the United States: results of the 2009 Asthma Insight and Management survey. Allergy Asthma Proc. 2012 Jan-Feb;33(1):54-64. doi: 10.2500/aap.2011.32.3518. Epub 2011 Dec 15.
PubMed 22309716Demoly P, Annunziata K, Gubba E, Adamek L. Repeated cross-sectional survey of patient-reported asthma control in Europe in the past 5 years. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi: 10.1183/09059180.00008111.
PubMed 22379176Eakin MN, Rand CS. Improving patient adherence with asthma self-management practices: what works? Ann Allergy Asthma Immunol. 2012 Aug;109(2):90-2. doi: 10.1016/j.anai.2012.06.009. No abstract available.
PubMed 22840247Tran N, Coffman JM, Sumino K, Cabana MD. Patient reminder systems and asthma medication adherence: a systematic review. J Asthma. 2014 Jun;51(5):536-43. doi: 10.3109/02770903.2014.888572. Epub 2014 Feb 13.
PubMed 24506699Foster JM, Usherwood T, Smith L, Sawyer SM, Xuan W, Rand CS, Reddel HK. Inhaler reminders improve adherence with controller treatment in primary care patients with asthma. J Allergy Clin Immunol. 2014 Dec;134(6):1260-1268.e3. doi: 10.1016/j.jaci.2014.05.041. Epub 2014 Jul 22.
PubMed 25062783Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
PubMed 24282112Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.
PubMed 15256389Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Kumar R, Seibold MA, Aldrich MC, Williams LK, Reiner AP, Colangelo L, Galanter J, Gignoux C, Hu D, Sen S, Choudhry S, Peterson EL, Rodriguez-Santana J, Rodriguez-Cintron W, Nalls MA, Leak TS, O'Meara E, Meibohm B, Kritchevsky SB, Li R, Harris TB, Nickerson DA, Fornage M, Enright P, Ziv E, Smith LJ, Liu K, Burchard EG. Genetic ancestry in lung-function predictions. N Engl J Med. 2010 Jul 22;363(4):321-30. doi: 10.1056/NEJMoa0907897. Epub 2010 Jul 7.
PubMed 20647190Park HW, Tantisira KG, Weiss ST. Pharmacogenomics in asthma therapy: where are we and where do we go? Annu Rev Pharmacol Toxicol. 2015;55:129-47. doi: 10.1146/annurev-pharmtox-010814-124543. Epub 2014 Sep 29.
PubMed 25292431Wechsler ME, Kunselman SJ, Chinchilli VM, Bleecker E, Boushey HA, Calhoun WJ, Ameredes BT, Castro M, Craig TJ, Denlinger L, Fahy JV, Jarjour N, Kazani S, Kim S, Kraft M, Lazarus SC, Lemanske RF Jr, Markezich A, Martin RJ, Permaul P, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Walter MJ, Wasserman SI, Israel E; National Heart, Lung and Blood Institute's Asthma Clinical Research Network. Effect of beta2-adrenergic receptor polymorphism on response to longacting beta2 agonist in asthma (LARGE trial): a genotype-stratified, randomised, placebo-controlled, crossover trial. Lancet. 2009 Nov 21;374(9703):1754-64. doi: 10.1016/S0140-6736(09)61492-6.
PubMed 19932356
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Mobile Health Application 2.0
- ClinicalTrials.gov ID
- NCT03248869
- Acronym / sponsor ID
- GCO 15-0063
- Conditions
- Asthma
- Keywords
- asthma, mobile application, mobile app, mobile health applications, asthma mobile health application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,752 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Apple Inc., Lifemap Solutions, Inc, Sage Bionetworks
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 14 Aug 2017 (actual)
- 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.
Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU).
Detailed description
Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU).
During the AMHA 2.0 study, the aims are to evaluate the feasibility of:
- Consenting and enrolling a small cohort of subjects with asthma recruited from Mount Sinai pulmonary clinics remotely via downloading the app
- Feasibility of use of an asthma e-diary and automated e-reminders for medications in this small cohort for one month
- Exploring if a small cohort of participants will share data from wearable health and fitness monitoring devices if they own and use such devices.
The primary enrollment period for AMHA 2.0 was met in September 2015. More than 7,000 individuals e-consented for the AMHA 2.0 study, providing more than 80,000 survey responses with many participants granting AMHA 2.0 investigators access to geo-location and wellness data. Data collected during the first six months of the AMHA 2.0 study has provided evidence to answer all primary outcome measures.
Continuation of the AMHA 2.0 protocol was approved in December 2015, expanding the study to a larger population who will be followed for a more extended period of time and will be recruited via availability of the AMHA in the Apple App Store in the US, UK, and Ireland. The latest modification submitted in January, adds an entirely new aim, OM6 and SA6, to the project to include a genetics module. The objectives for the continuation study are:
- To determine the feasibility of recruiting, consenting and enrolling a larger number of subjects remotely via the Apple App Store without direct participant contact during any phase of the study
- Assess the impact of continued use of an asthma e-diary and automated medication e-reminders for up to 2 years
- Explore the feasibility of sharing of data from wearable health and fitness monitoring devices (if applicable) from a larger cohort of patients for up to 2 years
- To test the medical accuracy of algorithms that may be used in future app versions to give specific feedback to participants based on information they input into the AMHA
- To investigate the association between DNA variants and asthma phenotypes including: asthma severity, symptom patterns, and medication use/response
This second phase of research is designed to continue the process of developing an AMHA that facilitates asthma self-monitoring, promotes positive behavioral changes, and reinforces adherence to treatment plans according to current asthma guidelines, all in a user-friendly fashion conducive to long term use.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A/B testing is a randomized statistical experiment with intervention and control study arms, A and B. New users, as of December 2015, will be stratified and randomized to different daily survey formats in order to test differences in daily survey participation rates. Since this was a mobile "app" based study, a first of its kind - which was available in the App store, it was possible to recruit widely in large numbers. Therefore, even though this was a feasibility study, the sample size was large.
| Arm | Type | Receives |
|---|---|---|
| Current Daily Survey | Active comparator | Other: Current Daily Surveyneed description |
| Mobile Health App (MHA) | Experimental | Other: Mobile Health AppParticipants download the mobile health app via the Apple App Store |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Self-reported physician diagnosed asthma
- Have an iPhone
- Sufficient English-language ability to participate in informed consent process, complete study assessments and understand the text in mobile phone-delivered interventions
Key exclusion criteria (5 listed)
- <18 years of age
- Not currently taking any asthma medications
- Does not own an iPhone or know how to handle a mobile phone
- Are unable to read or understand the study materials
- Current pregnancy
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 |
|---|---|---|
| Current Daily Surveyneed description | Other | Current Daily Survey |
| Mobile Health AppAlso: Asthma Mobile Health AppParticipants recruited, consented and enrolled via the AMHA and complete assessments using the app | Other | Mobile Health App (MHA) |
Primary outcome
Number of downloads
Time frame: 2 years
Number of people who downloaded AMHA
Percent of participants who aborted study participation
Time frame: 2 years
Percent of aborted study participants before completion inclusion/exclusion criteria
13 secondary outcomes
Frequency of use of the Daily asthma diary
Time frame: 2 years
Frequency of use of the Asthma Control (AC) questionnaire
Time frame: 2 years
Frequency of use of the Health Care Utilization (HCU) questionnaire
Time frame: 2 years
Percent of completion of Daily asthma diary
Time frame: 2 years
Percent of completion of the Asthma Control (AC) questionnaire
Time frame: 2 years
Percent of completion of the Health Care Utilization (HCU) questionnaire
Time frame: 2 years
Frequency of use of optional AMHA features
Time frame: 2 years
Asthma Control (AC) questionnaire
Time frame: up to 6 months
EuroQol 5D-5L (EQ-5D-5L)
Time frame: up to 6 months
Health Care Utilization (HCU) score
Time frame: up to 6 months
Associations between genetic markers and asthma severity
Time frame: 2 years
Associations between genetic markers and symptom patterns
Time frame: 2 years
Associations between genetic markers and medication use/response
Time frame: 2 years
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 14 Aug 2017.
- Background: PubMed 22309716Murphy KR, Meltzer EO, Blaiss MS, Nathan RA, Stoloff SW, Doherty DE. Asthma management and control in the United States: results of the 2009 Asthma Insight and Management survey. Allergy Asthma Proc. 2012 Jan-Feb;33(1):54-64. doi: 10.2500/aap.2011.32.3518. Epub 2011 Dec 15.
- Background: PubMed 22379176Demoly P, Annunziata K, Gubba E, Adamek L. Repeated cross-sectional survey of patient-reported asthma control in Europe in the past 5 years. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi: 10.1183/09059180.00008111.
- Background: PubMed 22840247Eakin MN, Rand CS. Improving patient adherence with asthma self-management practices: what works? Ann Allergy Asthma Immunol. 2012 Aug;109(2):90-2. doi: 10.1016/j.anai.2012.06.009. No abstract available.
- Background: PubMed 24506699Tran N, Coffman JM, Sumino K, Cabana MD. Patient reminder systems and asthma medication adherence: a systematic review. J Asthma. 2014 Jun;51(5):536-43. doi: 10.3109/02770903.2014.888572. Epub 2014 Feb 13.
- Background: PubMed 25062783Foster JM, Usherwood T, Smith L, Sawyer SM, Xuan W, Rand CS, Reddel HK. Inhaler reminders improve adherence with controller treatment in primary care patients with asthma. J Allergy Clin Immunol. 2014 Dec;134(6):1260-1268.e3. doi: 10.1016/j.jaci.2014.05.041. Epub 2014 Jul 22.
- Background: PubMed 24282112Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
- Background: PubMed 15256389Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 20647190Kumar R, Seibold MA, Aldrich MC, Williams LK, Reiner AP, Colangelo L, Galanter J, Gignoux C, Hu D, Sen S, Choudhry S, Peterson EL, Rodriguez-Santana J, Rodriguez-Cintron W, Nalls MA, Leak TS, O'Meara E, Meibohm B, Kritchevsky SB, Li R, Harris TB, Nickerson DA, Fornage M, Enright P, Ziv E, Smith LJ, Liu K, Burchard EG. Genetic ancestry in lung-function predictions. N Engl J Med. 2010 Jul 22;363(4):321-30. doi: 10.1056/NEJMoa0907897. Epub 2010 Jul 7.
- Background: PubMed 25292431Park HW, Tantisira KG, Weiss ST. Pharmacogenomics in asthma therapy: where are we and where do we go? Annu Rev Pharmacol Toxicol. 2015;55:129-47. doi: 10.1146/annurev-pharmtox-010814-124543. Epub 2014 Sep 29.
- Background: PubMed 19932356Wechsler ME, Kunselman SJ, Chinchilli VM, Bleecker E, Boushey HA, Calhoun WJ, Ameredes BT, Castro M, Craig TJ, Denlinger L, Fahy JV, Jarjour N, Kazani S, Kim S, Kraft M, Lazarus SC, Lemanske RF Jr, Markezich A, Martin RJ, Permaul P, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Walter MJ, Wasserman SI, Israel E; National Heart, Lung and Blood Institute's Asthma Clinical Research Network. Effect of beta2-adrenergic receptor polymorphism on response to longacting beta2 agonist in asthma (LARGE trial): a genotype-stratified, randomised, placebo-controlled, crossover trial. Lancet. 2009 Nov 21;374(9703):1754-64. doi: 10.1016/S0140-6736(09)61492-6.
- Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014.Link provided by the sponsor.
Related trials for Asthma
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled 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.
Yu-feng Y Chan, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current Daily Survey and Mobile Health App in people with Asthma, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 5 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Number of downloads (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT03248869, which also lists 11 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 14 Aug 2017.