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Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)

Comparison of Parasympathetic Activity in Mild, Moderate, and Severe Asthma With Fixed Airway Obstruction

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05550402
Acronym
PARASMA
Enrollment
60
Registered
2022-09-22
Start date
2024-02-17
Completion date
2024-06-30
Last updated
2024-02-20

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

Conditions

Airway Obstruction, Airway Remodeling, Asthma, Parasympathetic Nervous System Diseases

Keywords

asthma, fixed airway obstruction, spirometry, parasympathetic activity, well controlled

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.

Interventions

DRUGSalbutamol

Visit 1, After predosed spirometry is done, the patients will be received 4 puffs of salbutamol. 30 minutes later, if they meet the criteria of fixed airway obstruction based on ATS criteria, then they will continue to undergo serial spirometry at 1, 2, 3, and 4 hours. Then, the patients requested to be administered 4 puffs of ipratropium and do spirometry at 4.5 and 5 hours.

DRUGIpratropium Bromide

Visit 2, After predosed spirometry is done, the patients will be received 4 puffs of ipratropium they will continue to undergo serial spirometry at 30 minutes,1, 2, 3, and 4 hours. Then, the patients requested to be administered 4 puffs of salbutamol and do spirometry at 4.5 and 5 hours.

DRUGSalbutamol plus Ipratropium Bromide

Visit 3, After predosed spirometry is done, the patients will be received 4 puffs of a placebo, and they will do spirometry at 30 minutes, 1 and 2 hours (Placebo arm). Then, the patients requested to be administered 4 puffs of ipratropium and 4 puffs of salbutamol and do spirometry at 4.5 and 5 hours (Salbutamol plus ipratropium arm)

OTHERPlacebo

Visit 3, After predosed spirometry is done, the patients will be received 4 puffs of a placebo, and they will do spirometry at 30 minutes, 1 and 2 hours (Placebo arm).

Sponsors

Hat Yai Medical Education Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average FEV16 hourFEV1 determined from serial spirometry and calculated on the basis of area under the curve

Secondary

MeasureTime frameDescription
FEV1 at 6 h6 hourFEV1 at 6 hours post-dose
Maximum FEV16 hourMaximum FEV1 over the 6-hour serial assessments

Countries

Thailand

Contacts

Primary ContactNarongwit Nakwan, M.D.
naronak@hotmail.com0818984566
Backup ContactPattarawadee Taptawee, R.N.
taptawee@hotmail.co.th

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026