Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study) (PARASMA)
Asthma, Airway Obstruction, Airway Remodeling
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring asthma, fixed airway obstruction, spirometry, parasympathetic activity, well controlled
Eligibility Criteria
Inclusion Criteria:
- Asthmatic patients using low-dosed ICS/LABA or medium-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
- Patients who able to do spirometry without contraindication
Exclusion Criteria:
- Contraindication for spirometry
- Chest x-ray suggested any chronic lung diseased
- Contraindication for anticholinergic drug
- History of asthma exacerbation within 12 weeks prior to visit 1
- History of taking LAMA within 6 months prior to visit 1
Sites / Locations
- Hatyai Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Salbutamol then ipratropium
Ipratropium then salbutamol
Salbutamol plus ipratropium
Placebo
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.
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.
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)
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).