There are many people living with asthma or chronic obstructive pulmonary disease (COPD) who have not received a formal diagnosis, resulting in largely untreated respiratory symptoms. The identification of pulmonary diseases can help patients mitigate disease progression, alleviate symptoms, and reduce the need for exacerbation-related care. Authors of a study published in The New England Journal of Medicine aimed to identify symptomatic adults who have undiagnosed asthma or COPD and to couple early diagnosis of disease with a treatment strategy directed and selected by pulmonologists to determine whether early diagnosis and treatment of undiagnosed disease reduces health care use for respiratory illness and improves health outcomes.
For this study, a case-finding method was used to identify 508 adults aged 18 years and older within the community with respiratory symptoms and without a diagnosed lung disease. The identified patients were enrolled in a multicenter, randomized, controlled trial to determine whether early diagnosis and treatment can reduce the utilization of health care for respiratory illnesses and improve health outcomes. Additionally, participants were assigned to receive either intervention—which consists of an evaluation by a pulmonologist and an asthma-COPD educator who were instructed to initiate care based on current guidelines—or usual care by their primary care practitioner.
The study’s primary end point is annualized rate of participant-initiated health care utilization for respiratory illness (eg, asthma, COPD). Secondary end points include changes from baseline to 1 year in disease-specific quality of life, symptom burden, and forced expiratory volume in 1 second (FEV1).
Of the enrolled participants, 253 patients were assigned to the intervention group and the remaining 255 were assigned to the usual-care group. The investigators noted that a total of 16 study participants in the intervention group and 24 in the usual-care group had to withdraw from the story or died prior to the completion of the 12-month trial period. Additionally, 2 of these participants did not contribute data to the primary outcome because they either died or withdrew from the study within 30 days of the randomization.
During the 12-month trial period, 232 participants (92%) in the intervention group and 153 (60%) in the usual-care group began a new treatment for either asthma or COPD. Treatments included long-acting muscarinic antagonists, short-acting beta-agonists, long-acting beta-agonists, inhaled corticosteroids, among others, as well as combination regimens. Further, action plans were provided to 88 participants (35%), exercise advice was provided to 155 (61%), weight loss advice was provided to 56 (22%), and 20 (8%) were referred to a pulmonary rehabilitation program. Of the enrolled participants, there were 64 who were current smokers in the intervention group, of which 34 (53%) received pharmacologic treatment for smoking cessation.
Key Takeaways
- Early Diagnosis and Treatment Improve Outcomes: The study found that intervention treatment of undiagnosed asthma or chronic obstructive pulmonary disease (COPD) significantly reduced the annualized rate of participant-initiated health care for respiratory illnesses. The intervention group had a lower rate of health care events (0.53 events per person-year) compared with the usual-care group (1.12 events per person-year), demonstrating benefits of early and targeted intervention.
- Comprehensive Care Enhances Management: Participants in the intervention group not only started new treatments for asthma or COPD at a higher rate (92%) compared with the usual-care group (60%), but they also received additional support including action plans, exercise advice, weight loss advice, and referrals to pulmonary rehabilitation programs. The comprehensive approach in this group led to better management of their conditions and potentially better health outcomes.
- Significant Reduction in Primary Care Visits: The study showed a notable reduction in the rate of primary care visits for respiratory illness in the intervention group (0.36 visits per person-year) compared to the usual-care group (0.91 visits per person-year). This suggests that specialized intervention can lessen the burden on primary care providers and improve patient outcomes by providing more effective and focused care for respiratory conditions.
The findings demonstrated that annualized rate of participant-initiated health care use for respiratory illness was lower in the intervention group (0.53 events per person-year) than in the usual-care group (1.12 events per person-year; incidence rate ratio, 0.48; 95% CI, 0.36-0.63; P < .001). Additionally, the rate of hospitalization was 0.021 per person-year in the intervention group and 0.030 in the usual-care group (incidence rate ratio, 0.71; 95% CI, 0.17-2.99), with hospitalizations as result of either pneumonia or COPD exacerbation in both groups (intervention group: 2 total, 2 for pneumonia and 0 for COPD; usual-care: 3 total, 1 for pneumonia and 2 for COPD).
Further, the rate of emergency department visits was 0.069 per person-year in the intervention group and 0.075 in the usual-care group (incidence rate ratio, 0.92; 95% CI, 0.46-1.87). In addition, the rate of primary care visits for respiratory illness was 0.36 per person-year in the intervention group and 0.91 in the usual-care group (incidence rate ratio, 0.39; 95% CI, 0.29 to 0.53). The rate of specialist visits was also lower in the intervention group than in the usual-care group (0.085 vs 0.096 per person-year; incidence rate ratio, 0.89; 95% CI, 0.45-1.76).
There were 2 deaths that occurred in each of the trial groups during the 12-month trial period, of which 1 in each group died because of cardiac arrest, 1 in the intervention group because of lung cancer, and 1 in the usual-care group because of liver failure. Additionally, there were 12 serious adverse events (AEs) reported by patients that resulted in hospitalizations between the 2 groups (intervention: n = 5 and usual-care: n = 7). Additionally, a total of 24 AEs were reported by 21 participants in the intervention group, and 16 by 14 participants in the usual-care group. AEs included dizziness or syncope as well as muscle cramping, and according to the authors, these were most likely because of spirometry or prescribed respiratory medications.
Limitations of the trial include the insufficiency to detect differences in secondary outcomes or within subgroups, older patients (median age: 63 years) were more likely to participate, meaning younger patients were not closely evaluated, and results may not be generalizable to the US because Canadian health care systems were evaluated. Additionally, the authors note that pulmonologists, due to administered intervention care, were instructed to follow international guidelines; however, they were not provided with treatment algorithms and the authors did not monitor how frequently provision of care aligned with the guidelines.
The investigators note that although study results favored the intervention group, there were some indications in the usual-care group that suggest management of previously undiagnosed asthma or COPD by primary care providers may also be associated with positive changes within a year of diagnosis. Further, the authors are hopeful that these approaches can encourage patients to take a more active role in managing their health.
Reference
Aaron, SD, Vandemheen, KL, Whitmore, GA, et al. Early Diagnosis and Treatment of COPD and Asthma — A Randomized, Controlled Trial. N Engl J Med. 2024. doi:10.1056/NEJMoa2401389
