AsthmaPhase 1/2BOREASNCT04933383
Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics
A Phase 1/2 study testing AQ001S 0.125 mg/ml and Budesonide 0.125 mg/ml inhalation suspension in people with Asthma, run by Aquilon Pharmaceuticals S.A. at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- AQ001S 0.125 mg/ml and Budesonide 0.125 mg/ml inhalation suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jul 2021to 31 Jan 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index between 18.5 and 29 kg/m2.
- Documented clinical diagnosis of stable, persistent, asthma for at least 3 months
- Subjects who are ICS-naïve for minimum 60 days at Screening Visit.
- Positive methacholine (MCh) challenge test (concentration of MCh provoking an FEV1 fall of 20% [PC20] < 8 mg/ml or dose of MCh provoking an FEV1 fall of 20% [PD20] < 0.2 mg) in the last year.
- Post-bronchodilator FEV1 at least 80% of the predicted, documented in the last year.
- Clinical laboratory test results, 12-lead electrocardiogram (ECG), blood pressure and heart rate (supine) within normal reference range or judged to be not clinically significant by the Investigator.
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- Female subjects of childbearing potential should have a negative pregnancy test at Screening Visit and use a highly effective method of contraception.
- Reliable subjects who are willing to be available for the duration of the clinical trial and willing to comply with clinical trial procedures.
- Subjects who have the ability to understand the requirements of the clinical trial.
- Subjects who have given written informed consent.
Who cannot join
- Current smokers or recent (< 8 weeks) ex-smokers or ex-smokers if > 10 pack-years.
- Pregnant or breastfeeding female subjects.
- Inability to carry out pulmonary function testing.
- FEV1 < 70%.
- History of near-fatal asthma and/or intensive care unit admission for asthma symptoms.
- Exacerbations of asthma requiring oral steroids, hospitalization or change in asthma treatment in the previous three months.
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- Evidence of symptomatic chronic or acute respiratory infection in the previous 8 weeks.
- Diagnosis of chronic obstructive pulmonary disease (COPD) or bronchiectasis.
- Pulmonary malformations, tuberculosis, cystic fibrosis.
- History of hypersensitivity or existing contraindication to budesonide or any other Investigational Medicinal Product (IMP) ingredients.
- Untreated oral candidiasis.
- Immunosuppressive treatment, including systemic corticosteroids (e.g., oral, parenteral, ocular, nasal), within 28 days before Screening Visit.
- Use of ICS within 60 days before Screening Visit.
- Use of anti-leukotrienes, immunoglobulins, beta-blockers, digitalis, amiodarone, antifungals, macrolides, antidepressants, monoamine oxidase inhibitors, antiretroviral drugs, cholinesterase inhibitors, histamine, theophylline, non-steroidal anti-inflammatory drugs, anticholinergic drugs, neuroleptics, curariform drugs, antihistaminic (anti-H1) drugs, calcium channel blockers, long acting beta2-antagonists, mast cell stabilizers (e.g. natrium cromoglycate).
- History of alcohol or drug abuse.
- Unstable or life-threatening cardiac disease
- History or presence of prolonged QT interval (> 470 ms), or any other clinically significant ECG abnormalities as judged by the Investigator based on 12-lead ECG recordings at Screening Visit.
- Diabetes mellitus.
- Neuropsychiatric diseases.
- Clinically relevant laboratory abnormalities at Screening Visit.
- Blood or plasma donation within 30 days prior to Screening Visit.
- History or presence of malignancy of any system organ class (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years prior to Screening Visit, regardless of whether there is evidence of local recurrence or metastases.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the clinical trial.
- History or presence of any other clinically relevant disease of any major system organ class (e.g. cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological, neurological, psychiatric or orthopedic disease) as judged by the Investigator.
- Human immunodeficiency virus (HIV) and severe acute respiratory syndrome (SARS)-CoV-2 infections.
- Subjects who participated in an investigational trial within the 12 weeks prior to the start of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Active-controlled, Randomized, Open Label, Single-center, Multiple Dose, Crossover Clinical Trial to Assess the Efficacy, Safety and PK of AQ001S Compared to a Budesonide Inhalation Suspension in Adults With Mild Asthma
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.
Read the detailed description
Adults patients with mild asthma (18 to 65 years old), who are 'inhaled corticosteroid (ICS)'-naïve for minimum 60 days at Screening Visit will be enrolled in the study. The patients will be treated for 28 days. The primary endpoint will be assessed by a provocative concentration of methacholine that results in a 20% drop (PC20) in the first second forced expiratory volume (FEV1) as determined by methacholine challenge test. The pharmacokinetics (PK) endpoint, i.e. PK profile of budesonide in plasma, and pharmacodynamics (PD) endpoints, i.e. recording of symptom scores, use of reliever drugs as needed, biomarkers of airway inflammation and pulmonary function tests will be assessed during the study.
- Conditions
- Asthma
- Being tested
- AQ001S 0.125 mg/ml, Budesonide 0.125 mg/ml inhalation suspension
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQ001S 0.125 mg/mlDrug
Also called budesonide inhalation solution 0.125 mg/ml
administered by nebulization once daily
Budesonide 0.125 mg/ml inhalation suspensionDrug
Also called Budesonide inhalation suspension 0.125 mg/ml
administered by nebulization once daily
| Study group | Role | What they receive |
|---|---|---|
| AQ001S 0.125 mg/ml | Experimental | AQ001S 0.125 mg/ml is a budesonide inhalation solution administered by nebulization once daily. Receives: Drug: AQ001S 0.125 mg/ml; Drug: Budesonide 0.125 mg/ml inhalation suspension |
| budesonide inhalation suspension 0.125 mg/ml | Active comparator | Budesonide 0.125 mg/ml is a budesonide inhalation suspension administered by nebulization once daily. Receives: Drug: AQ001S 0.125 mg/ml; Drug: Budesonide 0.125 mg/ml inhalation suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test
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.
Measured: visit 1 (baseline) - visit 2 (at the end of Treatment Period 1) and visit 4 (end of Treatment Period 2)
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by collection of (Serious) Adverse Events
Measured: Over the treatment period, from the informed consent signature up to the end of second 29-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start23 Jul 2021
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquilon Pharmaceuticals S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Benoît Martinot, Principal investigator, Pneumocare SPRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933383
- Sponsor's protocol ID
- AQ-PRO-005
- Acronym
- BOREAS
- Status last verified
- Aug 2024
- First submitted
- 31 May 2021
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Active-controlled, Randomized, Open Label, Single-center, Multiple Dose, Crossover Clinical Trial to Assess the Efficacy, Safety and PK of AQ001S Compared to a Budesonide Inhalation Suspension in Adults With Mild Asthma
- ClinicalTrials.gov ID
- NCT04933383
- Acronym / sponsor ID
- BOREAS / AQ-PRO-005
- Conditions
- Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Aquilon Pharmaceuticals S.A.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adults patients with mild asthma (18 to 65 years old), who are 'inhaled corticosteroid (ICS)'-naïve for minimum 60 days at Screening Visit will be enrolled in the study. The patients will be treated for 28 days. The primary endpoint will be assessed by a provocative concentration of methacholine that results in a 20% drop (PC20) in the first second forced expiratory volume (FEV1) as determined by methacholine challenge test. The pharmacokinetics (PK) endpoint, i.e. PK profile of budesonide in plasma, and pharmacodynamics (PD) endpoints, i.e. recording of symptom scores, use of reliever drugs as needed, biomarkers of airway inflammation and pulmonary function tests will be assessed during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQ001S 0.125 mg/ml | Experimental | Drug: AQ001S 0.125 mg/ml, Drug: Budesonide 0.125 mg/ml inhalation suspensionAQ001S 0.125 mg/ml is a budesonide inhalation solution administered by nebulization once daily. |
| budesonide inhalation suspension 0.125 mg/ml | Active comparator | Drug: AQ001S 0.125 mg/ml, Drug: Budesonide 0.125 mg/ml inhalation suspensionBudesonide 0.125 mg/ml is a budesonide inhalation suspension administered by nebulization once daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Body mass index between 18.5 and 29 kg/m2.
- Documented clinical diagnosis of stable, persistent, asthma for at least 3 months
- Subjects who are ICS-naïve for minimum 60 days at Screening Visit.
- Positive methacholine (MCh) challenge test (concentration of MCh provoking an FEV1 fall of 20% [PC20] < 8 mg/ml or dose of MCh provoking an FEV1 fall of 20% [PD20] < 0.2 mg) in the last year.
- Post-bronchodilator FEV1 at least 80% of the predicted, documented in the last year.
Key exclusion criteria (26 listed)
- Current smokers or recent (< 8 weeks) ex-smokers or ex-smokers if > 10 pack-years.
- Pregnant or breastfeeding female subjects.
- Inability to carry out pulmonary function testing.
- FEV1 < 70%.
- History of near-fatal asthma and/or intensive care unit admission for asthma symptoms.
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 |
|---|---|---|
| AQ001S 0.125 mg/mlAlso: budesonide inhalation solution 0.125 mg/mladministered by nebulization once daily | Drug | AQ001S 0.125 mg/ml, budesonide inhalation suspension 0.125 mg/ml |
| Budesonide 0.125 mg/ml inhalation suspensionAlso: Budesonide inhalation suspension 0.125 mg/mladministered by nebulization once daily | Drug | AQ001S 0.125 mg/ml, budesonide inhalation suspension 0.125 mg/ml |
Primary outcome
Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test
Time frame: 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.
Incidence of Treatment-Emergent Adverse Events
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jean-Benoît Martinot principal investigator
Pneumocare SPRL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AQ001S 0.125 mg/ml and Budesonide 0.125 mg/ml inhalation suspension in people with Asthma, run by Aquilon Pharmaceuticals S.A. at 1 site in Belgium.
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 10 inclusion and 26 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: finished, as of the sponsor's last update on 3 Sep 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in PC20 After Each Treatment Period Assessed by Methacholine (MCh) Challenge Test (time frame: visit 1 (baseline) - visit 2 (at the end of Treatment Period 1) and visit 4 (end of Treatment Period 2)). The study lists 2 primary outcomes in all. 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 3 Sep 2024.