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

NCT07679321 | Recruiting

• 1 other identifier: XiangyaHr
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety/Depression and Asthma

Outcome Measures

Primary Outcomes (1)

• Acute asthma attack

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

  1 year

Interventions

No intervention measures OTHER

No intervention measures

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of asthma patients who meet all inclusion criteria of our research protocol. If a patient meets any of the exclusion criteria, they will not be included in the study scope.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

induced sputum, feces, blood

MeSH Terms

Conditions

Anxiety Disorders; Depression; Asthma

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: July 1, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (1)