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Evaluation of the Efficacy and Safety of Distilled Water Provocation Test in Diagnosing Bronchial Asthma: A Randomized, Single-Center, Prospective Cross-Over Validation Study

Evaluation of the Efficacy and Safety of Distilled Water Provocation Test in Diagnosing Bronchial Asthma: A Randomized, Single-Center, Prospective Cross-Over Validation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105197
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

Group B:Chloroacetylmethacholine excitation test
Group A:The distilled water provocation test

Sponsors

The Second Affiliated hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Applicants must be over 18 years old and under 65 years old. 2. Presence of symptoms suspected of asthma, such as recurrent wheezing, cough, chest tightness, etc. (> 8 weeks). 3. No use of inhaled hormones or discontinuation of > = 4 weeks. 4. Able to understand and comply with the requirements of the study, and willing to sign the informed consent form. 5. Able to complete pulmonary function tests independently. 6. Baseline FEV1 > = 70% predicted and baseline PEF > = 80% predicted.

Exclusion criteria

Exclusion criteria: 1. Have been diagnosed with other types of respiratory diseases (such as chronic obstructive pulmonary disease, tuberculosis, etc.). 2. Recent respiratory tract infection (< 4 weeks). 3. Use of drugs that affect airway responsiveness within the last month. 4. Have severe systemic diseases (such as heart disease, diabetes, etc.). 5. Pregnant or lactating women. 6. Those who are allergic to chlorethethiacholine or distilled water. 7. Those who have serious mental illness and cannot cooperate with the completion of the test. 8. Presence of significant dyspnea or full-lung wheezing. 9. Baseline FEV1 < 60% predicted.

Design outcomes

Primary

MeasureTime frame
PD20FEV1;

Secondary

MeasureTime frame
FEV1;PEF;

Countries

China

Contacts

Public ContactYiming Zeng

The Second Affiliated hospital of Fujian Medical University

zeng_yi_ming@126.com+86 595 2276 8177

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026