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NCT Number: 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

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

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location status: Recruiting

Location contact

Yuanyuan Li, Doctor

CONTACT

[email protected]

+8619976695523

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention measures

Other

No intervention measures

Primary outcomes

  1. Acute asthma attack

    Time frame: 1 year

    Number of acute asthma attacks in patients during follow-up period

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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