- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05550402
Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study) (PARASMA)
February 17, 2024 updated by: Narongwit Nakwan, Hat Yai Medical Education Center
Comparison of Parasympathetic Activity in Mild, Moderate, and Severe Asthma With Fixed Airway Obstruction
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Narongwit Nakwan, M.D.
- Phone Number: 0818984566
- Email: naronak@hotmail.com
Study Contact Backup
- Name: Pattarawadee Taptawee, R.N.
- Email: taptawee@hotmail.co.th
Study Locations
-
-
Songkhla
-
Hat Yai, Songkhla, Thailand, 90110
- Recruiting
- Hatyai Hospital
-
Contact:
- Narongwit Nakwan, M.D.
- Phone Number: 1223 074273100
- Email: naronak@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
Other Names:
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.
Other Names:
|
Active Comparator: 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.
|
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.
Other Names:
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.
Other Names:
|
Active Comparator: 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)
|
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)
|
Placebo Comparator: 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average FEV1
Time Frame: 6 hour
|
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
|
6 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FEV1 at 6 h
Time Frame: 6 hour
|
FEV1 at 6 hours post-dose
|
6 hour
|
Maximum FEV1
Time Frame: 6 hour
|
Maximum FEV1 over the 6-hour serial assessments
|
6 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Narongwit Nakwan, M.D., Hatyai medical Education Center, Hatyai Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2024
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
September 19, 2022
First Submitted That Met QC Criteria
September 19, 2022
First Posted (Actual)
September 22, 2022
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 17, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Respiration Disorders
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Pathological Conditions, Anatomical
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Respiratory Insufficiency
- Asthma
- Nervous System Diseases
- Airway Obstruction
- Autonomic Nervous System Diseases
- Airway Remodeling
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Adrenergic Agonists
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
- Bromides
- Ipratropium
Other Study ID Numbers
- 454554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Salbutamol
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Canisius-Wilhelmina HospitalRecruitingAsthma in Children | Agents, Anti AsthmaticNetherlands
-
Vastra Gotaland RegionEnrolling by invitationMusculoskeletal Diseases | Neuromuscular Diseases | Centronuclear Myopathy | Nemaline Myopathy | Congenital Myopathy | Myosin Storage MyopathySweden
-
Chiesi Farmaceutici S.p.A.CompletedBronchial AsthmaSpain, Italy, Russian Federation, Ukraine
-
University of Wisconsin, MadisonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedObesity | Pregnancy | PreeclampsiaUnited States
-
Shanghai Ninth People's Hospital Affiliated to...UnknownAdenoid Cystic CarcinomaChina
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic Obstructive
-
Research in Real-Life LtdTeva Branded Pharmaceutical Products R&D, Inc.CompletedAsthmaUnited Kingdom
-
The Hospital for Sick ChildrenUniversity Health Network, TorontoRecruiting