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Recruiting NCT07679321

The Impact of Anxiety/Depression on the Efficacy of Asthma Control Drugs and the Construction of a Predictive Model for the Risk of Acute Asthma Attacks

Observational Anxiety/Depression and Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention measures.
Who it may be relevant to
Registry conditions: Anxiety/Depression and Asthma. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this clinical trial is to explore the impact of anxiety/depression on the efficacy of asthma controller medications and to develop a risk prediction model for asthma acute exacerbations in patients with asthma. It will also analyze the association between anxiety/depression severity and asthma severity. The main questions it aims to answer are: Does anxiety/depression affect the therapeutic effect of asthma controller medications (e.g., asthma control level)? Can a reliable risk prediction model for asthma acute exacerbations be established based on anxiety/depression and other relevant factors? Researchers will conduct a prospective observational study to collect and analyze data from participants, without additional interventions beyond standard clinical care, to explore the above research questions. Participants will: Complete baseline assessments, including demographic information collection, medical history review, lung function tests, anxiety/depression evaluations (via GAD-7 and PHQ-9 scales), and provide biological samples (induced sputum, feces, blood) Undergo follow-up visits at 3, 6, 12, 18, and 24 months after baseline Report asthma symptoms, acute exacerbation events, and cooperate with required clinical checkups during follow-up

Interventions

  • Other No intervention measures
    No intervention measures

Primary outcome measures

  • Acute asthma attack [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Diagnosis of asthma according to the Global Initiative for Asthma (GINA) 2024 criteria.
  • Male or female patients aged 14 years or older.
  • Complete clinical data available.
  • Newly diagnosed asthma or stable asthma.
  • Receiving asthma controller medication.

Exclusion criteria

  • History of major lung diseases other than asthma, congestive heart failure, cor pulmonale, or recent cardiac or thoracic surgery.
  • Incomplete medical records.
  • Cognitive impairment or inability to complete psychological scale assessments.
  • Clinically diagnosed acute or chronic mental disorders, such as bipolar disorder or schizophrenia.
  • Current use of antidepressant or anti-anxiety medications.
  • Pregnancy or lactation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xiangya Hospital Central South University — Changsha

Identifiers

NCT: NCT07679321 · XiangyaHr

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗