AsthmaPARASMANCT05550402
Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)
A study testing Salbutamol, Ipratropium Bromide and Salbutamol plus Ipratropium Bromide in people with Asthma and Airway Obstruction, run by Hat Yai Medical Education Center at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Airway Obstruction, Airway Remodeling
- What is being tested?
- Salbutamol, Ipratropium Bromide and Salbutamol plus Ipratropium Bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 17 Feb 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pattarawadee Taptawee, R.N. contact
Thailand1 site, 1 recruiting
- Recruiting
Hatyai Hospital
Hat Yai, Changwat Songkhla, 90110
Narongwit Nakwan, M.D., 074273100 ext. 1223, naronak@hotmail.com
About this study
Official title: 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.
- Being tested
- Salbutamol, Ipratropium Bromide, Salbutamol plus Ipratropium Bromide, Placebo
- Keywords
- asthma, fixed airway obstruction, spirometry, parasympathetic activity, well controlled
- Medical subject headings
- Asthma, Airway Obstruction, Airway Remodeling, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Also called ventolin
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.
Ipratropium BromideDrug
Also called Atrovent
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.
Salbutamol plus Ipratropium BromideDrug
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)
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol then ipratropium | Active comparator | 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. Receives: Drug: Salbutamol; Drug: Ipratropium Bromide |
| Ipratropium then salbutamol | Active comparator | 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. Receives: Drug: Salbutamol; Drug: Ipratropium Bromide |
| Salbutamol plus ipratropium | Active comparator | 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) Receives: Drug: Salbutamol plus Ipratropium Bromide |
| Placebo | Placebo comparator | 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average FEV1
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
Measured: 6 hour
Secondary outcomes (2)
FEV1 at 6 h
FEV1 at 6 hours post-dose
Measured: 6 hour
Maximum FEV1
Maximum FEV1 over the 6-hour serial assessments
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start17 Feb 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hat Yai Medical Education Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongwit Nakwan, Hat Yai Medical Education Center
- Investigators
- Narongwit Nakwan, M.D., Principal investigator, Hatyai medical Education Center, Hatyai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550402
- Sponsor's protocol ID
- 454554
- Acronym
- PARASMA
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Parasympathetic Activity in Mild, Moderate, and Severe Asthma With Fixed Airway Obstruction
- ClinicalTrials.gov ID
- NCT05550402
- Acronym / sponsor ID
- PARASMA / 454554
- Keywords
- asthma, fixed airway obstruction, spirometry, parasympathetic activity, well controlled
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hat Yai Medical Education CenterUniversity, hospital or other
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salbutamol then ipratropium | Active comparator | Drug: Salbutamol, Drug: Ipratropium BromideVisit 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. |
| Ipratropium then salbutamol | Active comparator | Drug: Salbutamol, Drug: Ipratropium BromideVisit 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. |
| Salbutamol plus ipratropium | Active comparator | Drug: Salbutamol plus Ipratropium BromideVisit 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) |
| Placebo | Placebo comparator | Other: PlaceboVisit 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalbutamolAlso: ventolinVisit 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. | Drug | Ipratropium then salbutamol, Salbutamol then ipratropium |
| Ipratropium BromideAlso: AtroventVisit 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. | Drug | Ipratropium then salbutamol, Salbutamol then ipratropium |
| Salbutamol plus Ipratropium BromideVisit 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) | Drug | Salbutamol plus ipratropium |
| PlaceboVisit 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). | Other | Placebo |
Primary outcome
Average FEV1
Time frame: 6 hour
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
2 secondary outcomes
FEV1 at 6 h
Time frame: 6 hour
Maximum FEV1
Time frame: 6 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pattarawadee Taptawee, R.N. contact
Narongwit Nakwan, M.D. principal investigator
Hatyai medical Education Center, Hatyai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol, Ipratropium Bromide and Salbutamol plus Ipratropium Bromide in people with Asthma and Airway Obstruction, run by Hat Yai Medical Education Center at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Narongwit Nakwan, M.D. (0818984566, naronak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average FEV1 (time frame: 6 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.