A clinical study to assess the safety, systemic exposure and efficacy of a liquid for inhalation of budesonide (AQ001S) to treat asthma.

Phase 1

• Conditions: asthma; MedDRA version: 20.0Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002849-38-BE
• Lead Sponsor: Aquilon Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-04
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Subjects aged between 18 and 65 years, inclusive.
2.Body mass index = 30 kg/m2.
3.Documented clinical diagnosis of stable, persistent, asthma for at least 3 months, i.e.:
•for whom forced expiratory volume in one second (FEV1) = 70% of predicted, and
•treated with as-needed reliever medication (short-acting beta2-agonist-containing medication) only.
4.Subjects who are ICS-naïve for minimum 60 days at Screening Visit.
5.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.
6.Post-bronchodilator FEV1 at least 80% of the predicted, documented in the last year.
7.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.
8.Female subjects of childbearing potential should have a negative pregnancy test at Screening Visit.
9.Female subjects of childbearing potential using a highly effective method of contraception for at least 28 days and pursuing this contraception during the trial and for 28 days after the last administration of the investigational medicinal product (IMP).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Current smokers or recent (< 8 weeks) ex-smokers or ex-smokers if > 10 pack-years.
2.FEV1 < 70%.
3.History of near-fatal asthma and/or intensive care unit admission for asthma symptoms.
4.Exacerbations of asthma requiring oral steroids, hospitalization or change in asthma treatment in the previous three months.
5.Evidence of symptomatic chronic or acute respiratory infection in the previous 8 weeks.
6.Diagnosis of chronic obstructive pulmonary disease (COPD) or bronchiectasis.
7.Pulmonary malformations, tuberculosis, cystic fibrosis.
8.Untreated oral candidiasis.
9.Immunosuppressive treatment, including systemic corticosteroids (e.g., oral, parenteral, ocular, nasal), within 28 days before Screening Visit.
10.Unstable or life-threatening cardiac disease
11.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.
12.Diabetes mellitus.
13.Neuropsychiatric diseases.
14.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.
15.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified