A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma

NCT05472662 | Completed Phase 2 Results

• 1 other identifier: CLI-05993AB6-07
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IIa, multicentre, single dose, randomised, double blind, controlled, 2 way cross-over study to evaluate the potential for bronchoconstriction of the new HFA-152a propellant (single dose) versus the marketed HFA-134a propellant (single dose) in adults with mild asthma. HFA=Hydrofluoroalkane

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Safety: Relative Change From Baseline* in Forced Expiratory Volume in 1 s (FEV1) -- 15 Min Post-dose

  Safety: Relative change from baseline\* in forced expiratory volume in 1 s (FEV1) at the 15 min post-dose time point. Results are presented as adjusted mean and 95% confidence interval (CI.) The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. \*The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).

  At 15 min post-dose after T1.

Secondary Outcomes (13)

• Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points

  At 5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.

• Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose

  At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.

• Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points

  At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.

• Safety: Change From Baseline* in FEV1 Area Under the Concentration-time Curve From Time Zero to 3 Hours (AUC0-3h)

  At 3 h post-dose.

• Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points

  At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.

Study Arms (2)

Test

EXPERIMENTAL

Placebo HFA-152a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration.

Drug: Placebo 152a

Reference

PLACEBO COMPARATOR

Placebo HFA-134a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration.

Drug: Placebo 134a

Interventions

Placebo 152a DRUG

Placebo pressurised metered-dose inhaler (pMDI) formulated with the 152a propellant

Test

Placebo 134a DRUG

Placebo pressurised metered-dose inhaler (pMDI) formulated with the 134a propellant

Reference

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject's written informed consent obtained prior to any study related procedure.
• Gender and age: Male or female adults aged from 18 to 75 years old (inclusive).
• Diagnosis of asthma: documented established diagnosis of mild asthma for at least 6 months according to Step 1 of the Global Initiative for Asthma (GINA) 2021 guidelines.
• Lung function: subjects with a pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% of the predicted normal value and ≥1.5 L at screening and prior to randomisation, after appropriate wash-out from bronchodilators.
• Documented excessive variability in lung function.
• Current asthma therapy: as needed low-dose inhaled corticosteroids (ICS)-formoterol, as needed short-acting β2-agonists (SABA), or low-dose ICS whenever SABA was taken taken not more than twice a week (2 events) in the 4 weeks prior to screening or in the 6 weeks prior to randomisation.
• Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire© (ACQ-5) score \<1.5 at screening and prior to randomisation.
• Ability to use the inhalers.
• Ability to comply with the protocol. 10: Female subjects of non-childbearing potential (defined as physiologically incapable of becoming pregnant (i.e. postmenopausal or permanently sterile) and Female subjects of childbearing potential, who accepts the use of highly effective contraceptive methods during the study or with non-fertile male partners.
• \. Male subjects fulfilling one of the following criteria:
• Fertile male subjects with pregnant or non-pregnant women of childbearing potential (WOCBP) partners: they must be willing to use male condom from the signature of the Informed Consent Form (ICF) and until the follow-up visit/call, or;
• Non-fertile male subjects (contraception is not required in this case), or;
• Fertile male subjects with women of non-childbearing potential (WONCBP) partner (contraception is not required in this case).

You may not qualify if:

• History of "at risk" asthma.
• Recent exacerbation.
• Asthma requiring use of biologics.
• Respiratory disorders other than asthma.
• Lung cancer or history of lung cancer.
• Lung resection.
• Lower respiratory tract infection.
• Documented coronavirus disease 2019 (COVID-19) diagnosis.
• Smoking status: current smoker, or ex-smoker with a smoking history of ≥10 pack-years.
• Cancer or history of cancer (other than lung cancer);subject with active cancer or a history of cancer with less than 5 years disease-free survival time.
• Cardiovascular diseases: subjects who have known and clinically significant (CS) cardiovascular conditions.
• Electrocardiogram (ECG) criteria: any CS abnormal 12-lead ECG that, in the Investigator's opinion, would affect safety evaluations or place the subject at risk.
• Central nervous system disorders: subjects with a history of symptoms or significant neurological disease.
• Other concurrent diseases: subjects with historical or current evidence of uncontrolled concurrent disease such as, but not limited to, hyperthyroidism, diabetes mellitus or other endocrine disease, haematological disease, autoimmune disorders (e.g. rheumatoid arthritis), gastrointestinal disorders (e.g. poorly controlled peptic ulcer, gastroesophageal reflux disease), significant renal impairment or other disease or condition that might, in the judgement of the Investigator, place the subject at undue risk or potentially compromise the results or interpretations of the study.
• Laboratory abnormalities: subjects with CS laboratory abnormalities indicating a significant or unstable concomitant disease.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Medicine Evaluation Unit Limited

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Study Officials

• Dave Singh, MD

  Medicines Evaluation Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 25, 2022
• Study Start: August 3, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)