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NCT05550402: PARASMA
Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)
NA trial testing Salbutamol in Asthma in 60 participants. Status unknown.
1 June 2024
Quick facts
| Lead sponsor | Hat Yai Medical Education Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 17 February 2024 |
| Primary completion | 1 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Salbutamol (salbutamol) — full drug profile →
- Ipratropium Bromide — full drug profile →
- Salbutamol plus Ipratropium Bromide — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
- Airway Obstruction — all drugs for Airway Obstruction →
- Airway Remodeling — all drugs for Airway Remodeling →
- Parasympathetic Nervous System Diseases — all drugs for Parasympathetic Nervous System Diseases →
Sponsor
Hat Yai Medical Education Center — full company profile →
Who can join
Adults 18 to 60, any sex, with Asthma or Airway Obstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05550402
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hat Yai Medical Education Center trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05550402 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hat Yai Medical Education Center
- Last refreshed: 20 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05550402.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing