Trial Outcomes & Findings for Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics (NCT NCT04933383)

Last Updated: 2024-09-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

visit 1 (baseline) - visit 2 (at the end of Treatment Period 1) and visit 4 (end of Treatment Period 2)

Results posted on

2024-09-03

Participant Flow

Cross-over part of the study (treatment period 1) - Washout period of 2 weeks - Cross-over part of the study (treatment period 2)

Participant milestones

Participant milestones
Measure	Sequence A: AQ001S - Comparator AQ001S budesonide solution was administered for 29 (+2) days once daily (treatment period 1). Following a wash-out period of 14 (+2) days, the comparator Budesonide suspension was administered for 29 (+2) days once daily (treatment period 2).	Sequence B: Comparator - AQ001S The comparator Budesonide suspension was administered for 29 (+2) days once daily (treatment period 1). Following a wash-out period of 14 (+2) days, AQ001S budesonide solution was administered for 29 (+2) days once daily (treatment period 2).
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence A: AQ001S - Comparator n=11 Participants AQ001S budesonide solution was administered for 29 (+2) days once daily (treatment period 1). Following a wash-out period of 14 (+2) days, the comparator (budesonide suspension) was administered for 29 (+2) days once daily (treatment period 2).	Sequence B: Comparator - AQ001S n=12 Participants The comparator (budesonide suspension) was administered for 29 (+2) days once daily (treatment period 1). Following a washout period of 14 (+2) days, AQ001S budesonide solution was administered for 29 (+2) days once daily (treatment period 2).	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants	12 Participants n=107 Participants	23 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	36.3 years STANDARD_DEVIATION 11.2 • n=99 Participants	29.1 years STANDARD_DEVIATION 9.9 • n=107 Participants	32.5 years STANDARD_DEVIATION 10.9 • n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	8 Participants n=107 Participants	12 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	11 Participants n=99 Participants	12 Participants n=107 Participants	23 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Belgium	11 participants n=99 Participants	12 participants n=107 Participants	23 participants n=206 Participants
Body Mass Index (BMI)	24.38 kg/m² STANDARD_DEVIATION 2.91 • n=99 Participants	24.24 kg/m² STANDARD_DEVIATION 3.86 • n=107 Participants	24.31 kg/m² STANDARD_DEVIATION 3.36 • n=206 Participants

PRIMARY outcome

Timeframe: visit 1 (baseline) - visit 2 (at the end of Treatment Period 1) and visit 4 (end of Treatment Period 2)

Population: The efficacy population encompasses all subjects that completed both treatment periods and for which the primary efficacy parameter PC20 was available at baseline (visit 1) and after both treatment periods (visit 2 and visit 4).

Outcome measures

Outcome measures
Measure	AQ001S 0.125 mg/ml n=22 Participants AQ001S is a budesonide inhalation solution administered by nebulization once daily. AQ001S 0.125 mg/ml: administered by nebulization once daily	Budesonide Inhalation Suspension 0.125 mg/ml n=22 Participants The comparator is a budesonide inhalation suspension administered by nebulization once daily. Budesonide 0.125 mg/ml inhalation suspension: administered by nebulization once daily
Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test	3.7 mg/mL Interval 0.9 to 6.5	1.2 mg/mL Interval -0.7 to 3.0

PRIMARY outcome

Timeframe: Over the treatment period, from the informed consent signature up to the end of second 29-day treatment period

Population: The safety population includes all randomized subjects who received at least one dose of the study medication (AQ001S or comparator).

Incidence of Treatment-Emergent Adverse Events as assessed by collection of (Serious) Adverse Events

Outcome measures

Outcome measures
Measure	AQ001S 0.125 mg/ml n=23 Participants AQ001S is a budesonide inhalation solution administered by nebulization once daily. AQ001S 0.125 mg/ml: administered by nebulization once daily	Budesonide Inhalation Suspension 0.125 mg/ml n=23 Participants The comparator is a budesonide inhalation suspension administered by nebulization once daily. Budesonide 0.125 mg/ml inhalation suspension: administered by nebulization once daily
Incidence of Treatment-Emergent Adverse Events All-Cause Mortality	0 events	0 events
Incidence of Treatment-Emergent Adverse Events Serious Adverse Events	0 events	0 events
Incidence of Treatment-Emergent Adverse Events Other (not including serious) Adverse Events	3 events	10 events

Adverse Events

AQ001S 0.125 mg/ml

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Budesonide Inhalation Suspension 0.125 mg/ml

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AQ001S 0.125 mg/ml n=23 participants at risk AQ001S is a budesonide inhalation solution administered by nebulization once daily. AQ001S 0.125 mg/ml: administered by nebulization once daily	Budesonide Inhalation Suspension 0.125 mg/ml n=23 participants at risk The comparator Budesonide suspension is a budesonide inhalation suspension administered by nebulization once daily. Budesonide 0.125 mg/ml inhalation suspension: administered by nebulization once daily
Injury, poisoning and procedural complications Limb injury	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.	0.00% 0/23 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.
Nervous system disorders Headache	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.
Gastrointestinal disorders Toothache	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.	0.00% 0/23 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/23 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.	4.3% 1/23 • Number of events 2 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.
Infections and infestations COVID-19 pneumonia	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.	4.3% 1/23 • Number of events 1 • Adverse events/serious adverse events were recorded from the time the subjects signed the informed consent until the last study visit.

Additional Information

Clinical Operations

Aquilon Pharmaceuticals SA

Phone: 003242292800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication and disclosure of results of this trial must be consistent with Aquilon Pharmaceuticals publication policy. The rights of the investigator and the sponsor with regard to publication or disclosure of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER