Investigating the Role of Parasympathetic Activity in Asthma with Fixed Airway Obstruction
Comparison of Parasympathetic Activity in Mild, Moderate, and Severe Asthma With Fixed Airway Obstruction
This study is testing how certain treatments can help people with asthma and fixed airway obstruction breathe better by looking at the role of the nervous system in their lung function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hat Yai Medical Education Center Academic / other |
| Locations | 1 site (Hat Yai, Songkhla) |
| Trial ID | NCT05550402 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of parasympathetic activity on patients with mild to severe asthma who experience fixed airway obstruction. It aims to understand how chronic airway inflammation and airway remodeling contribute to lung function decline in these individuals. Participants will receive various treatments, including Salbutamol and Ipratropium Bromide, to assess their effects on lung function and asthma control. The study will include patients with specific criteria related to asthma severity and lung function measurements.
Who should consider this trial
Good fit: Ideal candidates are asthmatic patients classified as mild to severe with fixed airway obstruction and controlled asthma symptoms.
Not a fit: Patients with contraindications for spirometry or those with chronic lung diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for asthma patients with fixed airway obstruction, enhancing their quality of life.
How similar studies have performed: Previous studies have indicated the importance of airway remodeling in asthma, suggesting that this approach may yield valuable insights, although the specific focus on parasympathetic activity in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Asthmatic patients classified by severity Mild (achieved control with using low-dose ICS or as-needed ICS-formoterol) or Moderate (achieved controlled with using low-dose ICS/LABA or Severe ((achieved controlled with using medium to high dose ICS/LABA) * Post-bronchodilator (Salbutamol) FEV1/FVC ratio less than 0.75 or below the Lower Limit of Normal (LLN) and Post-bronchodilator (Salbutamol) FEV1 predicted \< 80% with or without bronchodilator response * History of smoking less than 10 pack-years or current smoking * Patients who able to do spirometry without contraindication * asthma control was defined by ACQ6 \< 1.5 Exclusion Criteria: * Contraindication for spirometry * Chest x-ray suggested any chronic lung diseased * Contraindication for anticholinergic drug * History of asthma exacerbation within 12 weeks before visit 1 * History of taking LAMA within 6 months before visit 1
Where this trial is running
Hat Yai, Songkhla
- Hatyai Hospital — Hat Yai, Songkhla, Thailand (Recruiting)
Study contacts
- Principal investigator: Narongwit Nakwan, M.D. — Hatyai medical Education Center, Hatyai Hospital
- Study coordinator: Narongwit Nakwan, M.D.
- Email: naronak@hotmail.com
- Phone: 0818984566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.