Clinical trial NCT05550402: Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)
Official title: Comparison of Parasympathetic Activity in Mild, Moderate, and Severe Asthma With Fixed Airway Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Airway Obstruction
Airway Remodeling
Parasympathetic Nervous System Diseases
Keywords: asthma
fixed airway obstruction
spirometry
parasympathetic activity
well controlled
Lead sponsor: Hat Yai Medical Education Center
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: In asthma, the significant role of pathogenesis is chronic airway inflammation, bronchial hyperresponsiveness, and variable airflow obstruction. Asthma with irreversible or fixed airflow obstruction (FAO) is a clinical phenotype resulting from chronic airway inflammation with having longer disease duration, suggesting that airway remodeling contributes to the decline in lung function seen in individuals with asthma. Although this condition frequently occurs in patients with severe asthma, there are pieces of evidence occurring in those with mild to moderate asthma. According to previous research, low lung function, FEV1 less than 60% predicted, is a robust independent predictor of subsequent asthma attacks and other asthma outcomes, including asthma control and SABA use. In a recent study, the patients with mild to moderate asthma who received mild to medium dosed inhaled corticosteroid plus long-acting beta-2 agonist with or without asthma control showed evidence of FAO with or without bronchodilator reversibility. Therefore parasympathetic activity may be affected by FAO in those patients. The autonomic nervous system plays an essential role in asthma, especially from the parasympathetic, promoting bronchoconstriction and regulating airway inflammation and remodeling. This study hypothesizes that a cholinergic mechanism may play a significant role in FAO across patients with mild, moderate, and severe asthma. This might increase the fundamental evidence leading to early-step treatment with anti-cholinergic medication in early asthma severity driven by FAO.


Eligibility 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

Primary outcomes:
measure: Average FEV1
timeFrame: 6 hour
Secondary outcomes:
measure: FEV1 at 6 h
timeFrame: 6 hour
measure: Maximum FEV1
timeFrame: 6 hour
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Hatyai Hospital
state: Songkhla
Study officials:
affiliation: Hatyai medical Education Center, Hatyai Hospital
name: Narongwit Nakwan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: