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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Placebo HFA-152a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. |
|
| Reference | Placebo Comparator | Placebo HFA-134a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo 152a | Drug | Placebo pressurised metered-dose inhaler (pMDI) formulated with the 152a propellant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points | Safety: Relative change from baseline* in FEV1 at all the other post-dose time points (5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1). Results are presented as adjusted mean and 95% 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). |
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Inclusion Criteria:
11. 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).
Exclusion criteria:
16. Hypersensitivity: history of hypersensitivity to any of the study medications components.
17.Subjects mentally or legally incapacitated. 18. Recent eye surgery or any condition where raised intracranial pressure (caused by forceful exhalation) would be harmful.
19. For female subjects only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation.
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh, MD | Medicines Evaluation Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Evaluation Unit Limited | Manchester | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | HFA-152a Followed by HFA-134a | HFA-152a and HFA-134a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. Placebo HFA-152a and Placebo HFA-134a: Placebo pMDI formulated with the propellant HFA-152a/ HFA-134a. In this study arm, HFA-152a was used during period 1 and HFA-134a was used during period 2. |
| FG001 | HFA-134a Followed by HFA-152a | HFA-134a and HFA-152a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. Placebo HFA-134a and Placebo HFA-152a: Placebo pMDI formulated with the propellant HFA-134a/HFA-152a. In this study arm, HFA-134a was used during period 1 and HFA-152a was used during period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HFA-152a Followed by HFA-134a | HFA-152a and HFA-134a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. Placebo HFA-152a and Placebo HFA-134a: Placebo pMDI formulated with the propellant HFA-152a/ HFA-134a. In this study arm, HFA-152a was used during period 1 and HFA-134a was used during period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | 95% Confidence Interval | percent change | At 15 min post-dose after T1. |
|
Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs.
Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | Placebo HFA-152a propellant via pMDI: Administration: Single-dose administration. Placebo 152a: Placebo pMDI formulated with the 152a propellant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Transparency | Chiesi Farmaceutici S.p.A. | + 39 0521 2791 | clinicaltrials_info@chiesi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2022 | Nov 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2022 | Nov 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo 134a | Drug | Placebo pressurised metered-dose inhaler (pMDI) formulated with the 134a propellant |
|
| 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 | Safety: Absolute change from baseline* in FEV1 at all post-dose time points. Results are presented as adjusted mean and 95% 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 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 | Safety: Number and percentage of subjects with a relative change from baseline* in FEV1 at each post-dose time point <-15%. 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 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) | Change from baseline* in FEV1 area under the concentration-time curve from time zero to 3 hours (AUC0-3h). Results show the change from baseline in FEV1 AUC(0-3h) corrected for Time, in litres 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 3 h post-dose. |
| Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points | Safety: Relative change from baseline* in peak expiratory flow (PEF) at all post-dose time points. 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 PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0). | At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1. |
| Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points | Safety: Absolute change from baseline* in PEF at all post-dose time points. 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 PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0). | At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1. |
| Safety: Subjects With Use of Rescue Medication -- 3 h Post Dose | Number and percentage of subjects with use of rescue medication in the 3 h post dose. | 3 h post-dose. |
| Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure | Safety and tolerability: Mean change from baseline in the Vital Signs -- Diastolic Blood Pressure | At 45 min, 1.75 h, 2.75 h post dose. |
| Safety and Tolerability: Vital Signs -- Systolic Blood Pressure | Safety and tolerability: Mean change from baseline in the Vital Signs -- Systolic Blood Pressure | At 45 min, 1.75 h, 2.75 h post dose. |
| Safety and Tolerability: ECG Parameter -- Heart Rate | Safety and tolerability: Mean change from baseline in the ECG parameter -- Heart rate | At 45 min, 1.75 h, 2.75 h post dose. |
| Safety and Tolerability: ECG Parameter -- PR Interval | Safety and tolerability: Mean change from baseline in the ECG parameter -- PR interval. | At 45 min, 1.75 h, 2.75 h post dose. |
| Safety and Tolerability: ECG Parameter -- QRS | Safety and tolerability: Mean change from baseline in the ECG parameter -- QRS interval. | At 45 min, 1.75 h, 2.75 h post dose. |
| Safety and Tolerability: ECG Parameter -- QTcF Interval | Safety and tolerability: Mean change from baseline in the ECG parameter -- QTcF interval. | At 45 min, 1.75 h, 2.75 h post dose. |
| BG001 |
| HFA-134a Followed by HFA-152a |
HFA-134a and HFA-152a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. Placebo HFA-134a and Placebo HFA-152a: Placebo pMDI formulated with the propellant HFA-134a/HFA-152a. In this study arm, HFA-134a was used during period 1 and HFA-152a was used during period 2. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Smoking status at screening | Count of Participants | Participants |
|
| Duration of smoking | Mean | Full Range | years |
|
| Number of pack-years | Pack years smoked: multiply the number of packs smoked per day by the number of years smoked | Mean | Full Range | pack-years |
|
| Time since first asthma diagnosis | Mean | Full Range | years |
|
| Asthma medication at study entry | Count of Participants | Participants |
|
| Number of exacerbations in the previous 12 months | Mean | Full Range | Number of exacerbations |
|
| Number of participants with exacerbations (0 or 1) in the previous 12 months, | Count of Participants | Participants |
|
| Time since the last exacerbation | This item presents data on the time since the last exacerbation (in months) and takes into account duration of longer than 12 months since the last exacerbation. Only participants with available date of the last exacerbation were considered. | Mean | Full Range | months |
|
| Asthma Control Questionnaire 5 (ACQ-5) total score at screening | The Asthma Control Questionnaire 5 (ACQ-5) is a self-administered questionnaire which includes five questions on asthma symptoms experienced during the past week. Subjects had to score each of the questions on a scale of zero to six, where zero = excellent control of the symptom and six = extremely poor control. The overall score of the ACQ-5 was the mean of the five responses. Subjects had to have an overall score of <1.5 to be eligible for inclusion in this study (inclusion criterion). | Mean | Full Range | score |
|
| Asthma Control Questionnaire 5 (ACQ-5) total score on Day 1, pre-dose | The Asthma Control Questionnaire 5 (ACQ-5) is a self-administered questionnaire which includes five questions on asthma symptoms experienced during the past week. Subjects had to score each of the questions on a scale of zero to six, where zero = excellent control of the symptom and six = extremely poor control. The overall score of the ACQ-5 was the mean of the five responses. Subjects had to have an overall score of <1.5 to be eligible for inclusion in this study (inclusion criterion). | Mean | Full Range | score |
|
| OG000 | Test | Placebo HFA-152a propellant via pMDI: Administration: Single-dose administration. Placebo 152a: Placebo pMDI formulated with the 152a propellant |
| OG001 | Reference | Placebo HFA-134a propellant via pMDI: Administration: Single-dose administration. Placebo 134a: Placebo pMDI formulated with the 134a propellant |
|
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| Secondary | Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points | Safety: Relative change from baseline* in FEV1 at all the other post-dose time points (5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1). Results are presented as adjusted mean and 95% 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). | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | 95% Confidence Interval | percent change | At 5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1. |
|
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| Secondary | Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose | Safety: Absolute change from baseline* in FEV1 at all post-dose time points. Results are presented as adjusted mean and 95% 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). | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | 95% Confidence Interval | Liter | At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1. |
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| Secondary | Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points | Safety: Number and percentage of subjects with a relative change from baseline* in FEV1 at each post-dose time point <-15%. The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0). | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Count of Participants | Participants | At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1. |
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| Secondary | Safety: Change From Baseline* in FEV1 Area Under the Concentration-time Curve From Time Zero to 3 Hours (AUC0-3h) | Change from baseline* in FEV1 area under the concentration-time curve from time zero to 3 hours (AUC0-3h). Results show the change from baseline in FEV1 AUC(0-3h) corrected for Time, in litres 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). | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Standard Deviation | Litres | At 3 h post-dose. |
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| Secondary | Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points | Safety: Relative change from baseline* in peak expiratory flow (PEF) at all post-dose time points. 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 PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0). | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Standard Deviation | percent change | At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1. |
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| Secondary | Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points | Safety: Absolute change from baseline* in PEF at all post-dose time points. 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 PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0). | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Standard Deviation | Litres/min | At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1. |
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| Secondary | Safety: Subjects With Use of Rescue Medication -- 3 h Post Dose | Number and percentage of subjects with use of rescue medication in the 3 h post dose. | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Count of Participants | Participants | 3 h post-dose. |
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| Secondary | Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure | Safety and tolerability: Mean change from baseline in the Vital Signs -- Diastolic Blood Pressure | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Full Range | mmHg | At 45 min, 1.75 h, 2.75 h post dose. |
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| Secondary | Safety and Tolerability: Vital Signs -- Systolic Blood Pressure | Safety and tolerability: Mean change from baseline in the Vital Signs -- Systolic Blood Pressure | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Full Range | mmHg | At 45 min, 1.75 h, 2.75 h post dose. |
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| Secondary | Safety and Tolerability: ECG Parameter -- Heart Rate | Safety and tolerability: Mean change from baseline in the ECG parameter -- Heart rate | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Full Range | beats/min | At 45 min, 1.75 h, 2.75 h post dose. |
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| Secondary | Safety and Tolerability: ECG Parameter -- PR Interval | Safety and tolerability: Mean change from baseline in the ECG parameter -- PR interval. | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Full Range | msec | At 45 min, 1.75 h, 2.75 h post dose. |
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| Secondary | Safety and Tolerability: ECG Parameter -- QRS | Safety and tolerability: Mean change from baseline in the ECG parameter -- QRS interval. | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Full Range | msec | At 45 min, 1.75 h, 2.75 h post dose. |
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| Secondary | Safety and Tolerability: ECG Parameter -- QTcF Interval | Safety and tolerability: Mean change from baseline in the ECG parameter -- QTcF interval. | Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a). | Posted | Mean | Full Range | msec | At 45 min, 1.75 h, 2.75 h post dose. |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | Reference | Placebo HFA-134a propellant via pMDI: Administration: Single-dose administration. Placebo 134a: Placebo pMDI formulated with the 134a propellant | 0 | 25 | 0 | 25 | 3 | 25 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
Investigators should inform Chiesi Farmaceutici S.p.A. before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 30 min post-dose |
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| 1 h post-dose |
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| 1.5 h post-dose |
|
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| 3 h post-dose |
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|
| Statistical analysis performed on the data at 30 min post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.782 | Adjusted mean difference | 0.23 | 2-Sided | 95 | -1.45 | 1.90 | Equivalence | Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits [-10% ; +10%]. |
| Statistical analysis performed on the data at 1 h post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.599 | Adjusted mean difference | -0.40 | 2-Sided | 95 | -1.97 | 1.16 | Equivalence | Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits [-10% ; +10%]. |
| Statistical analysis performed on the data at 1.5 h post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.815 | Adjusted mean difference | -0.13 | 2-Sided | 95 | -1.24 | 0.99 | Equivalence | Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits [-10% ; +10%]. |
| Statistical analysis performed on the data at 3 h post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.294 | Adjusted mean difference | -0.69 | 2-Sided | 95 | -2.01 | 0.64 | Equivalence | Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits [-10% ; +10%]. |
| 15 min post-dose |
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| 30 min post-dose |
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| 1 h post-dose |
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| 1.5 h post-dose |
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| 3 h post-dose |
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Statistical analysis performed on the data at 15 min post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate. |
| ANCOVA |
| 0.085 |
| Adjusted mean difference |
| 0.061 |
| 2-Sided |
| 95 |
| -0.009 |
| 0.130 |
| Other |
Assess differences between treatment groups. |
| Statistical analysis performed on the data at 30 min post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.858 | Adjusted mean difference | 0.004 | 2-Sided | 95 | -0.045 | 0.054 | Other | Assess differences between treatment groups. |
| Statistical analysis performed on the data at 1 h post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.632 | Adjusted mean difference | -0.011 | 2-Sided | 95 | -0.058 | 0.036 | Other | Assess differences between treatment groups. |
| Statistical analysis performed on the data at 1.5 h post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.846 | Adjusted mean difference | -0.003 | 2-Sided | 95 | -0.038 | 0.031 | Other | Assess differences between treatment groups. |
| Statistical analysis performed on the data at 3 h post-dose timepoint. Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate. | ANCOVA | 0.282 | Adjusted mean difference | -0.024 | 2-Sided | 95 | -0.068 | 0.021 | Other | Assess differences between treatment groups. |
| 30 min post-dose |
|
| 1 h post-dose |
|
| 1 h 30 min post-dose |
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| 3 h post-dose |
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| 15 min post-dose |
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| 30 min post-dose |
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| 1 h post-dose |
|
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| 1 h 30 min post-dose |
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| 3 h post-dose |
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| 15 min post-dose |
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| 30 min post-dose |
|
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| 1 h post-dose |
|
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| 1 h 30 min post-dose |
|
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| 3 h post-dose |
|
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| 45 min post dose (change from baseline) |
|
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| 1.75 h post dose (change from baseline) |
|
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| 2.75 h post dose (change from baseline) |
|
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| 45 min post dose (change from baseline) |
|
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| 1.75 h post dose (change from baseline) |
|
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| 2.75 h post dose (change from baseline) |
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| 1.75 h post dose (change from baseline) |
|
| 2.75 h post dose (change from baseline) |
|
| 1.75 h post dose (change from baseline) |
|
| 2.75 h post dose (change from baseline) |
|
| 1.75 h post dose (change from baseline) |
|
| 2.75 h post dose (change from baseline) |
|
| 1.75 h post dose (change from baseline) |
|
| 2.75 h post dose (change from baseline) |
|