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Clinical Trials/NCT05550402
NCT05550402
Recruiting
Not Applicable

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

Hat Yai Medical Education Center1 site in 1 country60 target enrollmentFebruary 17, 2024

Overview

Phase
Not Applicable
Intervention
Salbutamol
Conditions
Asthma
Sponsor
Hat Yai Medical Education Center
Enrollment
60
Locations
1
Primary Endpoint
Average FEV1
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2024
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Narongwit Nakwan

Asst. Prof.

Hat Yai Medical Education Center

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

Arms & Interventions

Salbutamol then ipratropium

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.

Intervention: Salbutamol

Salbutamol then ipratropium

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.

Intervention: Ipratropium Bromide

Ipratropium then salbutamol

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.

Intervention: Salbutamol

Ipratropium then salbutamol

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.

Intervention: Ipratropium Bromide

Salbutamol plus ipratropium

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)

Intervention: Salbutamol plus Ipratropium Bromide

Placebo

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).

Intervention: Placebo

Outcomes

Primary Outcomes

Average FEV1

Time Frame: 6 hour

FEV1 determined from serial spirometry and calculated on the basis of area under the curve

Secondary Outcomes

  • FEV1 at 6 h(6 hour)
  • Maximum FEV1(6 hour)

Study Sites (1)

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