Trial Outcomes & Findings for Functional Respiratory Imaging Study (DARWiIN) (NCT NCT04876677)
NCT ID: NCT04876677
Last Updated: 2026-04-09
Results Overview
siVaw was measured using Functional Respiratory Imaging (FRI) at Total Lung Capacity (TLC). siVaw represents the 3D reconstruction and quantification of the volume of air within the segmented airway tree. Higher siVaw values indicate a reduction in airway obstruction and improved ventilation efficiency in the lungs. For patients with COPD, siVaw is typically reduced due to airway obstruction and structural changes in the lungs. The siVaw comparisons were made on 'untrimmed' airways SO that all visible generations in a given scan (from Visit 2 or 3 respectively) were used in order to capture all available volume information. The data were summarized by the descriptive statistics for actual values at each timepoint.
COMPLETED
PHASE3
25 participants
V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days)
2026-04-09
Participant Flow
In total, 45 patients were screened of whom 20 were screening failures. The other 25 patients were enrolled and received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg. All enrolled and treated patients completed the study, and 23 patients were included in the PP analysis set due to eligibility criteria violations.
Screening visit was performed 6 weeks ± 2 days before Visit 2. The eligibility (inclusion/exclusion criteria) such as BMI, medical and smoking hystory, hystory of alcohol and drug abuse, vital signs, ECG test, pregnancy test, serology test, documented COVID-19 diagnosis, blood analysis, urine test, intake of concomitants medications were assessed.
Participant milestones
| Measure |
CHF5993 DPI 100/6/12.5 μg
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
SAF Population
|
25
|
|
Overall Study
PP Population
|
23
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Functional Respiratory Imaging Study (DARWiIN)
Baseline characteristics by cohort
| Measure |
CHF5993 DPI 100/6/12.5 μg
n=25 Participants
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg.
|
|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 7.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=36 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=36 Participants
|
|
BMI
|
27.71 kg/m²
STANDARD_DEVIATION 5.05 • n=36 Participants
|
PRIMARY outcome
Timeframe: V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days)Population: Per protocol (PP) analysis set: all patients from the safety set, except patients without any valid evaluation of FRI after the baseline or with important protocol deviations impacting the analysis populations.
siVaw was measured using Functional Respiratory Imaging (FRI) at Total Lung Capacity (TLC). siVaw represents the 3D reconstruction and quantification of the volume of air within the segmented airway tree. Higher siVaw values indicate a reduction in airway obstruction and improved ventilation efficiency in the lungs. For patients with COPD, siVaw is typically reduced due to airway obstruction and structural changes in the lungs. The siVaw comparisons were made on 'untrimmed' airways SO that all visible generations in a given scan (from Visit 2 or 3 respectively) were used in order to capture all available volume information. The data were summarized by the descriptive statistics for actual values at each timepoint.
Outcome measures
| Measure |
CHF5993 DPI 100/6/12.5 μg - PP Population
n=23 Participants
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg. However, only 23 patients were included in the Per Protocol (PP) Population due to eligibility criteria violations.
|
|---|---|
|
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose
V3 pre-dose, TLC
|
1.3550 liters
Standard Deviation 0.6014
|
|
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose
Baseline / V2 pre-dose, TLC
|
1.4088 liters
Standard Deviation 0.6647
|
PRIMARY outcome
Timeframe: V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days)Population: Per protocol (PP) analysis set: all patients from the safety set, except patients without any valid evaluation of FRI after the baseline or with important protocol deviations impacting the analysis populations.
siRaw was measured using Functional Respiratory Imaging (FRI) at TLC. siRaw represents the 3D reconstruction and quantification of resistance to airflow within the segmented airway tree. Lower siRaw values indicate improved airway patency, reduced airflow resistance, and enhanced ventilation efficiency in the lungs. For patients with COPD, siRaw is elevated due to airway narrowing, obstruction, and other structural changes in the lungs. The siRaw was evaluated using 'trimmed' data, meaning that only airway generations visible in both scans (i.e., the same airways) were used. The use of trimmed data in Multidetector computed tomography (MDCT) ensures that differences between scans are solely due to changes in airway calibre, not variations in the number of airway generations included in Computational Fluid Dynamics (CFD) calculations. The data were summarized by the descriptive statistics for actual values at each timepoint.
Outcome measures
| Measure |
CHF5993 DPI 100/6/12.5 μg - PP Population
n=22 Participants
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg. However, only 23 patients were included in the Per Protocol (PP) Population due to eligibility criteria violations.
|
|---|---|
|
Trimmed Airway Volume (siRaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose
Baseline / V2 pre-dose, TLC
|
0.7160 cmH₂O·s
Standard Deviation 0.4034
|
|
Trimmed Airway Volume (siRaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose
V3 pre-dose, TLC
|
0.8492 cmH₂O·s
Standard Deviation 0.5947
|
SECONDARY outcome
Timeframe: V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V2 within 60-120 min post-dose (assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days) and V3 within 60-120 min post-dose (assessed at week 12 ± 2 days)Population: Per protocol (PP) analysis set: all patients from the safety set, except patients without any valid evaluation of FRI after the baseline or with important protocol deviations impacting the analysis populations.
Airway volume (siVaw) was measured using Functional Respiratory Imaging (FRI) at TLC. siVaw quantifies the volume of air in the segmented airway tree. Higher siVaw values indicate reduced airway obstruction and improved ventilation. For this outcome, siVaw was assessed in distal lung regions, using 'untrimmed' data to include all visible airway generations. The data were summarized by the descriptive statistics for actual values at each timepoint.
Outcome measures
| Measure |
CHF5993 DPI 100/6/12.5 μg - PP Population
n=23 Participants
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg. However, only 23 patients were included in the Per Protocol (PP) Population due to eligibility criteria violations.
|
|---|---|
|
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
Baseline / V2 pre-dose, TLC
|
1.4088 liters
Standard Deviation 0.6647
|
|
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V2 post-dose, TLC
|
1.8706 liters
Standard Deviation 0.4954
|
|
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 pre-dose, TLC
|
1.3550 liters
Standard Deviation 0.6014
|
|
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 post-dose, TLC
|
1.9805 liters
Standard Deviation 0.6390
|
SECONDARY outcome
Timeframe: V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V2 within 60-120 min post-dose (assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days), V3 within 60-120 min post-dose (assessed at week 12 ± 2 days)Population: Per protocol (PP) analysis set: all patients from the safety set, except patients without any valid evaluation of FRI after the baseline or with important protocol deviations impacting the analysis populations.
Airway volume (siVaw) was measured using Functional Respiratory Imaging (FRI) at FRC. siVaw quantifies the air volume in the segmented airway tree at the end of a normal exhalation, expressed in milliliters (mL). Higher siVaw values at FRC indicate reduced airway obstruction and improved residual ventilation. In this outcome, siVaw was assessed in central and distal lung regions using 'untrimmed' data, ensuring all visible airway generations were included. Percent change in siVaw was calculated to evaluate treatment effects at these time points: Baseline (V2 pre-dose) to post-dose at V3, reflecting long-term improvements. Pre-dose to post-dose at V2, assessing the acute effect of SERETIDE™ DISKUS™ DPI. Pre-dose to post-dose at V3, assessing the acute effect of CHF5993 DPI. Percentage change from time point t at time point t1 was defined as follows: 100\*((value at time point t - value at time point t1) / value at time point t1)
Outcome measures
| Measure |
CHF5993 DPI 100/6/12.5 μg - PP Population
n=23 Participants
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg. However, only 23 patients were included in the Per Protocol (PP) Population due to eligibility criteria violations.
|
|---|---|
|
Untrimmed siVaw for Distal Region at Functional Residual Capacity (FRC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
Baseline / V2 pre-dose, FRC
|
0.6321 percent change of lung volume
Standard Deviation 0.3164
|
|
Untrimmed siVaw for Distal Region at Functional Residual Capacity (FRC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V2 post-dose, FRC
|
1.0204 percent change of lung volume
Standard Deviation 0.3404
|
|
Untrimmed siVaw for Distal Region at Functional Residual Capacity (FRC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 pre-dose, FRC
|
0.6982 percent change of lung volume
Standard Deviation 0.3198
|
|
Untrimmed siVaw for Distal Region at Functional Residual Capacity (FRC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 post-dose, FRC
|
1.0442 percent change of lung volume
Standard Deviation 0.3825
|
SECONDARY outcome
Timeframe: V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V2 within 60-120 min post-dose (assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days), V3 within 60-120 min post-dose (assessed at week 12 ± 2 days)Population: Per protocol (PP) analysis set: all patients from the safety set, except patients without any valid evaluation of FRI after the baseline or with important protocol deviations impacting the analysis populations.
Airway resistance (siRaw) was measured using FRI at TLC. siRaw quantifies airflow resistance within the segmented airway tree during inspiration. Lower siRaw values indicate reduced airway resistance, improved airway patency, and enhanced ventilation. For this outcome, siRaw was assessed in central and distal lung regions using 'untrimmed' data, ensuring all visible airway generations were included. The data were summarized by the descriptive statistics for actual values at each timepoint.
Outcome measures
| Measure |
CHF5993 DPI 100/6/12.5 μg - PP Population
n=23 Participants
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg. However, only 23 patients were included in the Per Protocol (PP) Population due to eligibility criteria violations.
|
|---|---|
|
Trimmed siRaw Via Functional Respiratory Imaging (FRI) for Distal Region at Total Lung Capacity (TLC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
Baseline / V2 pre-dose, TLC
|
0.7160 cmH₂O·s
Standard Deviation 0.4034
|
|
Trimmed siRaw Via Functional Respiratory Imaging (FRI) for Distal Region at Total Lung Capacity (TLC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V2 post-dose, TLC
|
0.3685 cmH₂O·s
Standard Deviation 0.1594
|
|
Trimmed siRaw Via Functional Respiratory Imaging (FRI) for Distal Region at Total Lung Capacity (TLC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 pre-dose, TLC
|
0.8492 cmH₂O·s
Standard Deviation 0.5947
|
|
Trimmed siRaw Via Functional Respiratory Imaging (FRI) for Distal Region at Total Lung Capacity (TLC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 post-dose, TLC
|
0.3121 cmH₂O·s
Standard Deviation 0.1416
|
SECONDARY outcome
Timeframe: V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V2 within 60-120 min post-dose (assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days), V3 within 60-120 min post-dose (assessed at week 12 ± 2 days)Population: Per protocol (PP) analysis set: all patients from the safety set, except patients without any valid evaluation of FRI after the baseline or with important protocol deviations impacting the analysis populations.
Airway resistance (siRaw) was measured using Functional Respiratory Imaging (FRI) at Functional Residual Capacity (FRC). siRaw quantifies airflow resistance within the segmented airway tree at the end of a normal exhalation, expressed in cmH₂O·s. Lower siRaw values at FRC indicate reduced airway obstruction and improved airflow efficiency. For this outcome, siRaw was assessed in central and distal lung regions using 'untrimmed' data to include all visible airway generations. The data were summarized by the descriptive statistics for actual values at each timepoint.
Outcome measures
| Measure |
CHF5993 DPI 100/6/12.5 μg - PP Population
n=22 Participants
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg. However, only 23 patients were included in the Per Protocol (PP) Population due to eligibility criteria violations.
|
|---|---|
|
Trimmed siRaw for Distal Region Using Functional Respiratory Imaging (FRI) at Functional Residual Capacity (FRC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
Baseline / V2 pre-dose, FRC
|
0.4981 cmH₂O·s
Standard Deviation 0.3383
|
|
Trimmed siRaw for Distal Region Using Functional Respiratory Imaging (FRI) at Functional Residual Capacity (FRC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V2 post-dose, FRC
|
0.2200 cmH₂O·s
Standard Deviation 0.1664
|
|
Trimmed siRaw for Distal Region Using Functional Respiratory Imaging (FRI) at Functional Residual Capacity (FRC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 pre-dose, FRC
|
0.3625 cmH₂O·s
Standard Deviation 0.4733
|
|
Trimmed siRaw for Distal Region Using Functional Respiratory Imaging (FRI) at Functional Residual Capacity (FRC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose
V3 post-dose, FRC
|
0.1889 cmH₂O·s
Standard Deviation 0.1453
|
Adverse Events
CHF5993 DPI 100/6/12.5 μg - SAF Population
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CHF5993 DPI 100/6/12.5 μg - SAF Population
n=25 participants at risk
All patients (25 subjects) received CHF5993 as follows:
\- Treatment period (6 weeks): two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) 400/24/50 µg.
After the screening visit (V1) that was to be performed 6 weeks ± 2 days before Visit 2 (V2), eligible patients were to undergo a 6-week run-in period with fluticasone dipropionate (FP)/salmeterol (SLM) DPI 500/50 µg (SERETIDE™ DISKUS™).
At the end of the run-in period (V2), patients were to be switched to the treatment period with BDP/FF/GB DPI (CHF5993) for 6 weeks until Visit 3 (V3).
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB): During the treatment period all patients, (25 subjects) received two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, giving a total daily dose of BDP/FF/GB 400/24/50 µg.
|
|---|---|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 3 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
|
Nervous system disorders
Sciatica
|
4.0%
1/25 • Number of events 1 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
|
Gastrointestinal disorders
Hiatus hernia
|
4.0%
1/25 • Number of events 1 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural calcification
|
8.0%
2/25 • Number of events 2 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
4.0%
1/25 • Number of events 1 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
4.0%
1/25 • Number of events 1 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
4.0%
1/25 • Number of events 1 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • Number of events 1 • Throughout the study, from screening visit (Week 0, Visit 1), till follow up visit (Week 14 ± 2 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results of this study may be published or presented at scientific meetings. If a publication is presented by the Investigator, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Data from individual study sites must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER