RecruitingNot Applicable

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

China256 participantsStarted 2024-12-01

Plain-language 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

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute asthma attack

Timeframe: 1 year

Trial details

NCT IDNCT07679321

SponsorXiangya Hospital of Central South University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-30

View on ClinicalTrials.gov More Anxiety/Depression and Asthma trials