Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge TestPrimary· visit 1 (baseline) - visit 2 (at the end of Treatment Period 1) and visit 4 (end of Treatment Period 2)
At Visit 1 (baseline), Visit 2 (29-day treatment period 1) and Visit 4 (29-day treatment period 2), a MCh challenge test will be performed, i.e. up to the administration of a concentration of MCh provoking an FEV1 fall of 20% (PC20). FEV1 is measured by spirometry. The change in PC20 from baseline to the end of each period (two periods) was assessed.
Group
Value
95% CI
AQ001S 0.125 mg/ml
3.7
0.9 – 6.5
Budesonide Inhalation Suspension 0.125 mg/ml
1.2
-0.7 – 3.0
Incidence of Treatment-Emergent Adverse EventsPrimary· Over the treatment period, from the informed consent signature up to the end of second 29-day treatment period
Incidence of Treatment-Emergent Adverse Events as assessed by collection of (Serious) Adverse Events
All-Cause Mortality
Group
Value
95% CI
AQ001S 0.125 mg/ml
0
Budesonide Inhalation Suspension 0.125 mg/ml
0
Serious Adverse Events
Group
Value
95% CI
AQ001S 0.125 mg/ml
0
Budesonide Inhalation Suspension 0.125 mg/ml
0
Other (not including serious) Adverse Events
Group
Value
95% CI
AQ001S 0.125 mg/ml
3
Budesonide Inhalation Suspension 0.125 mg/ml
10
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a prospective, active-controlled, randomized, open label, single-center, multiple dose, two-period crossover clinical trial to assess the efficacy, safety and pharmacokinetics of AQ001S compared to a budesonide inhalation suspension (comparator) in adults with mild asthma.
Both treatments will be administered by nebulization.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Other Aquilon Pharmaceuticals S.A. trials
Trials by the same sponsor.
NCT05148312 — Single-dose AQ001S PK Study in Healthy Volunteers
· Phase 1
· completed
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· Phase 2
· terminated
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aquilon Pharmaceuticals S.A.
Last refreshed: 3 September 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/NCT04933383.