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

Primary Purpose

Asthma, Airway Obstruction, Airway Remodeling

Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Salbutamol
Ipratropium Bromide
Salbutamol plus Ipratropium Bromide
Placebo
Sponsored by
Hat Yai Medical Education Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Salbutamol then ipratropium

Ipratropium then salbutamol

Salbutamol plus ipratropium

Placebo

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

FEV1 at 6 h
FEV1 at 6 hours post-dose
Maximum FEV1
Maximum FEV1 over the 6-hour serial assessments

Full Information

First Posted
September 19, 2022
Last Updated
October 4, 2023
Sponsor
Hat Yai Medical Education Center
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1. Study Identification

Unique Protocol Identification Number
NCT05550402
Brief Title
Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)
Acronym
PARASMA
Official Title
Comparison of Parasympathetic Activity in Mild, Moderate, and Severe Asthma With Fixed Airway Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hat Yai Medical Education Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Airway Obstruction, Airway Remodeling, Parasympathetic Nervous System Diseases
Keywords
asthma, fixed airway obstruction, spirometry, parasympathetic activity, well controlled

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Salbutamol then ipratropium
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ipratropium then salbutamol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Salbutamol plus ipratropium
Arm Type
Active Comparator
Arm Description
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 Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Salbutamol
Other Intervention Name(s)
ventolin
Intervention Description
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 Type
Drug
Intervention Name(s)
Ipratropium Bromide
Other Intervention Name(s)
Atrovent
Intervention Description
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 Type
Drug
Intervention Name(s)
Salbutamol plus Ipratropium Bromide
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Average FEV1
Description
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
Time Frame
6 hour
Secondary Outcome Measure Information:
Title
FEV1 at 6 h
Description
FEV1 at 6 hours post-dose
Time Frame
6 hour
Title
Maximum FEV1
Description
Maximum FEV1 over the 6-hour serial assessments
Time Frame
6 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Narongwit Nakwan, M.D.
Phone
0818984566
Email
naronak@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pattarawadee Taptawee, R.N.
Email
taptawee@hotmail.co.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narongwit Nakwan, M.D.
Organizational Affiliation
Hatyai medical Education Center, Hatyai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hatyai Hospital
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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