Observational Study of Characteristics, Treatment and Outcomes With Severe Asthma in the United States (CHRONICLE)

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

The CHRONICLE Study: A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals With Severe Asthma in the United States

ClinicalTrials.gov ID

NCT03373045

Acronym / sponsor ID

D3250R00023

Conditions

Asthma

Keywords

Severe asthma, Monoclonal antibody, Corticosteroid, Non-interventional

Study type

Observational

Recruitment status

Completed

Enrolment

18 participants (actual)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Collaborators

Parexel, MedImmune LLC

Study start

27 Feb 2018 (actual)

Primary completion

14 Feb 2025 (actual)

Study completion

14 Feb 2025 (actual)

First posted

14 Dec 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.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

5 Years

Number of arms

1

Who may qualify

Ages

18 to 130 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

It is estimated that at least 1500 patients in the US with a confirmed diagnosis of severe asthma will be enrolled by a diverse set of asthma specialists (eg, allergists and pulmonologists who treat asthma) from academic and community-based centers.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Healthcare utilization- hospitalizations, clinic Visits, and asthma exacerbations

   Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.

   Longitudinal changes of Healthcare utilization will be measured using directly collected information from medical, hospital, and pharmacy records to provide a supplementary comprehensive assessment of each patient's healthcare utilization during the study period.

2. Asthma treatment

   Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.

   Asthma medications with dose and start/stop dates including all FDA-approved and standard of care treatments for asthma will be assessed. Longitudinal changes in asthma treatment will also be assessed.

3. Treatment adherence

   Time frame: At baseline, every 1 month, through study completion, assessed up to 7 years.

   Extraction of electronic medical, hospital, and pharmacy records will take place at study close and potentially at interim time points to provide a supplementary assessment of each patient's healthcare resource utilization. Longitudinal changes in patient reported treatment adherence will also be assessed.

4. Asthma control test (ACT)

   Time frame: Change from baseline, every 1 month, through study completion, assessed up to 4 years.

   Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 item, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). In 2022, the ACT survey will be removed, and only the AIRQ will be solicited monthly.

5. Patient-reported asthma exacerbations

   Time frame: Change from baseline, every 1 month, through study completion, assessed up to 4 years.

   Asthma exacerbations, the primary analytical definition will be worsening of asthma that leads to any of the following: Use of systemic corticosteroids (or a temporary increase in a stable corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids. An emergency department or urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. In 2022, the asthma exacerbations survey will be removed, and only the AIRQ will be solicited monthly.

6. Asthma Impairment and Risk Questionnaire (AIRQ)

   Time frame: At baseline, every 1 month, through study completion, assessed up to 4 years

   AIRQ is a 10-item, equally weighted, yes/no composite asthma control questionnaire that includes 7 impairment and 3 risk items. AIRQ scores range from 0 to 10, with lower scores representing better controlled asthma.

7. Work Productivity and Activity Impairment Asthma questionnaire (WPAI-Asthma)

   Time frame: At baseline, every 3 months, through study completion, assessed up to 7 years.

   Patient-reported productivity impairment assessment including work productivity, activity impairment, and disability will be collected via the WPAI-Asthma. Information will only be collected from procedures that are part of the patient's routine clinical care. WPAI Asthma questionnaire is calculated from 0 to 10 score (0 indicates-Asthma had no effect on my work/ daily activities and 10 indicates Asthma completely prevented me from working score/ doing my daily activities).

8. St. George's Respiratory Questionnaire (SGRQ)

   Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.

   Patient-reported assessment of asthma quality of life will be collected via the SGRQ. SGRQ, a disease specific health-related quality of life measure developed for both asthma and chronic obstructive pulmonary disease (COPD) patients. The SGRQ has 50 items and scores are calculated for 3 domains (symptoms, activity, and impact [psychosocial]) as well as total score. Symptoms - this component is concerned with the effect of respiratory symptoms, their frequency and severity. Impacts (psychosocial) - covers a range of aspects concerned with social functioning and psychological disturbances resulting from respiratory disease Activity - concerned with activities that cause or are limited by breathlessness. Total score summarizes the impact of the disease on overall health status. The score is expressed as a percentage of overall impairment, where 100 represents worst possible health status and 0 indicates best possible health status.

9. Global evaluation of treatment effectiveness (GETE)

   Time frame: At baseline, every 6 months, through study completion, assessed maximum up to 7 years.

   Patient evaluation of asthma treatment effectiveness will be measured using GETE; a simple measure of perceived treatment effectiveness. The patient will grade the overall treatment effectiveness using the following criteria: excellent (complete control of asthma); good (marked improvement of asthma); moderate (discernible, but limited improvement in asthma); poor (no appreciable change in asthma); or worsening (of asthma).

10. Number of Participants With Adverse Events associated with corticosteroid therapy

    Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.

    Frequency of relevant medical events such as weight gain (change in BMI), hypertension, dyslipidemia, pneumonia, bone densitometry results, osteoporosis / osteopenia, hip and spinal fractures, avascular necrosis, cataract, glaucoma, diabetes mellitus, cardiovascular disease, Cushing's syndrome, adrenal insufficiency, peptic ulcer disease, myopathy, pseudotumor cerebri, mood disturbance, and insomnia or sleep disturbance.

11. Relevant respiratory medical events

    Time frame: At baseline, every 6 months, through study completion,assessed up to 7 years.

    Frequency of relevant respiratory medical events such as pneumonia, pleural effusion, chronic bronchitis, allergic rhinitis.

12. Respiratory comorbidities

    Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.

    Prevalence of respiratory comorbidities such as chronic obstructive pulmonary disease (COPD), bronchiectasis, alpha-1 anti-trypsin deficiency, Churg- Strauss syndrome (eosinophilic granulomatosis with polyangiitis [EGPA]), airway stenosis, cystic fibrosis, allergic bronchopulmonary aspergillosis,chronic eosinophilic pneumonia, bronchiolitis obliterans, immunodeficiency, primary ciliary dyskinesia, atelectasis, arterial hypertension, pulmonary hypertension, neuromuscular disease, allergic rhinitis, chronic rhinosinusitis, and pulmonary embolism.

13. Non-respiratory comorbidities

    Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.

    Prevalence of non-respiratory comorbidities such as diabetes, thyroid disease, cardiac disease, etc.

14. Events of special interest

    Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.

    Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis, or mortality.

15. Complete blood count with differential including blood eosinophil count.

    Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.

    To assess complete blood count with differential including blood eosinophil count as a variable for asthma evaluation.

16. Total immunoglobulin E (IgE)

    Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.

    To assess total IgE as a variable for asthma evaluation.

17. Radiographic changes in asthma evaluation.

    Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.

    Radiographic changes in asthma evaluation included chest X-rays (dates, views, description of major chest findings), Chest computed tomography scan (dates, high resolution (yes/no), intravenous contrast (yes/no), description of major findings). Radiographic asthma evaluation conducted as part of routine care.

18. Forced Vital Capacity (FVC)

    Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.

    FEV1 (liters and % predicted) will be assessed as a variable for asthma evaluation.

19. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.

    FEV1 (liters and % predicted) will be assessed as a variable for asthma evaluation.

20. Fractional exhaled nitric oxide (FENO)

    Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.

    To assess FENO as a variable for asthma evaluation.

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 24 Sep 2025.
• Derived from this study: PubMed 42716466Canonica GW, Christoff GC, Tsai MJ, Tran TN, Townend J, Scelo G, Beastall A, Bulathsinhala L, Busby J, Lindsley AW, Moore WC, Panettieri RA Jr, Heffler E, Cardini C, Guida G, Wang E, Wechsler ME, Chapman N, Hoyte F, Katial RK, Otsu K, Porsbjerg CM, Bjerrum AS, von Bulow A, Hansen S, Hilberg O, Julius Hakansson KE, Sondergaard MB, Ulrik CS, Heaney LG, Jackson DJ, Patel PH, Pfeffer PE, Ryan D, Kuna P, Bergeron C, Aaron SD, Abercromby S, Bhutani M, Chapman KR, Cote A, Davis BE, Dorscheid DR, Hoshyari L, Philipenko B, Sadatsafavi M, Serajeddini H, Larenas-Linnemann D, Cosio BG, Perez-de-Llano L, Torres-Duque CA, Fernandez-Sanchez MJ, Garcia E, Bolivar-Grimaldos F, Jimenez-Maldonado L, Cano-Rosales DJ, Solarte I, Schleich F, Louis R, Al-Lehebi R, Bulkhi AA, Habis Y, Al-Ahmad M, Mahboub B, Salameh L, Pitrez PM, Iwanaga T, Hozawa S, Matsumoto H, Nagano T, Tajiri T, Fonseca JA, Alves da Silva A, Loureiro CC, Cristhina de Azevedo Soares Dos Santos H, Papadopoulos NG, Kostikas K, Gaga M, Gogali A, Kallieri M, Loukides S, Makris M, Ntakoula M, Papaioannou AI, Paraskevopoulos G, Psarros F, Perng DW, Hsiao YH, Fu PK, Sheu CC, Aarli BB, Popov TA, Koh MS, Liew MF, Pang PH, Lee Tan T, Tay TR, Rhee CK, Maspero J, Ardusso LRF, Franchi ME, Sivori M, Stok AM, Yanez A, Lugogo N, Mohan A, Mitchell PD, Altraja A, Salvi S, Costello RW, Denton EJ, Hew M, Jenkins C, Langton D, Middleton PG, Peters MJ, Lehtimaki L, Bourdin A, Taille C, Taube C, Csoma Z, Ludviksdottir D, van Boven JFM, Fingleton J, Emery H, Lough G, Perugini V, Bjermer L, Maselli DJ, Pleasants RA, Ambrose CS, Emmanuel B, Emmas C, Menzies-Gow AN, Parulekar AD, Carter V, Eleangovan N, Murray RB, Price CA, Blakey JD, Price DB; ISAR GLEAM Working Group. Assessing the impact of earlier initiation of biologics on clinical remission and other outcomes in a global real-life severe asthma cohort from CHRONICLE, ISAR and OPCRD. Chest. 2026 Sep 9:S0012-3692(26)06552-9. doi: 10.1016/j.chest.2026.06.076. Online ahead of print.
• Derived from this study: PubMed 42433269Mohan A, Panettieri RA Jr, Moore WC, Lugogo NL, Zhou W, Lindsley AW, Carstens DD, Ambrose CS. Biologic effectiveness increases with earlier biologic initiation after severe asthma onset. J Allergy Clin Immunol Glob. 2026 Jun 11;5(5):100746. doi: 10.1016/j.jacig.2026.100746. eCollection 2026 Sep.
• Derived from this study: PubMed 42242757Boakye-Dankwa E, Kiddle SJ, Koo HN, Harper AR, Ambrose CS, Douglas IJ, Quint JK. A self-controlled case series to evaluate the effects of clinical trial eligibility criteria on biologic-associated reductions in severe asthma exacerbations: an analysis of the CHRONICLE study. Eur Respir J. 2026 Oct 22;68(4):2502196. doi: 10.1183/13993003.02196-2025. Print 2026 Oct.
• Derived from this study: PubMed 41501790Panettieri RA Jr, Mohan A, Lugogo NL, Ledford DK, Carstens DD, Ambrose CS. Outcomes after biologic initiation among patients with severe asthma and normal lung function in the CHRONICLE study. Respir Res. 2026 Jan 7;27(1):5. doi: 10.1186/s12931-025-03439-8.
• Derived from this study: PubMed 39398317Ledford DK, Carr WW, Moore WC, Lugogo NL, Mohan A, Chipps B, Mackie AR, Lindsley AW, Spahn J, Ambrose CS. Reduced Effectiveness of Anti-IgE Treatment Among Adults with Severe Asthma with Older Age of Asthma Onset: Results from the CHRONICLE Study. J Asthma Allergy. 2024 Oct 9;17:977-982. doi: 10.2147/JAA.S476774. eCollection 2024.
• Derived from this study: PubMed 37506846Ledford DK, Soong W, Carr W, Trevor J, Tan L, Carstens D, Ambrose CS. Real-world severe asthma biologic administration and adherence differs by biologic: CHRONICLE study results. Ann Allergy Asthma Immunol. 2023 Nov;131(5):598-605.e3. doi: 10.1016/j.anai.2023.07.017. Epub 2023 Jul 26.
• Derived from this study: PubMed 36906262Chipps BE, Soong W, Panettieri RA Jr, Carr W, Gandhi H, Zhou W, Cook B, Llanos JP, Ambrose CS. Number of patient-reported asthma triggers predicts uncontrolled disease among specialist-treated patients with severe asthma. Ann Allergy Asthma Immunol. 2023 Jun;130(6):784-790.e5. doi: 10.1016/j.anai.2023.03.001. Epub 2023 Mar 10.
• Derived from this study: PubMed 35728746Panettieri RA Jr, Ledford DK, Chipps BE, Soong W, Lugogo N, Carr W, Mohan A, Carstens D, Genofre E, Trudo F, Ambrose CS. Biologic use and outcomes among adults with severe asthma treated by US subspecialists. Ann Allergy Asthma Immunol. 2022 Oct;129(4):467-474.e3. doi: 10.1016/j.anai.2022.06.012. Epub 2022 Jun 19.
• Derived from this study: PubMed 34374622Panettieri RA Jr, Chipps BE, Moore WC, Soong W, Carr WW, Kreindler JL, O'Quinn S, Trudo F, Ambrose CS. Differing perceptions of asthma control and treatment effectiveness by patients with severe asthma and treating subspecialists in the United States. J Asthma. 2022 Sep;59(9):1859-1868. doi: 10.1080/02770903.2021.1963766. Epub 2021 Nov 5.
• Derived from this study: PubMed 34273485Trevor J, Lugogo N, Carr W, Moore WC, Soong W, Panettieri RA Jr,, Desai P, Trudo F, Ambrose CS. Severe asthma exacerbations in the United States:: Incidence, characteristics, predictors, and effects of biologic treatments. Ann Allergy Asthma Immunol. 2021 Nov;127(5):579-587.e1. doi: 10.1016/j.anai.2021.07.010. Epub 2021 Jul 15.
• Derived from this study: PubMed 34211280Soong W, Chipps BE, O'Quinn S, Trevor J, Carr WW, Belton L, Trudo F, Ambrose CS. Health-Related Quality of Life and Productivity Among US Patients with Severe Asthma. J Asthma Allergy. 2021 Jun 25;14:713-725. doi: 10.2147/JAA.S305513. eCollection 2021.
• Derived from this study: PubMed 32765156Ambrose CS, Chipps BE, Moore WC, Soong W, Trevor J, Ledford DK, Carr WW, Lugogo N, Trudo F, Tran TN, Panettieri RA Jr. The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results. Pragmat Obs Res. 2020 Jul 16;11:77-90. doi: 10.2147/POR.S251120. eCollection 2020.
• CSR SynopsisLink provided by the sponsor.
• Individual participant dataSharing planned: No

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Referral and contact

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