Trial · NCT03084718

An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects

NCT03084718, Phase 2, Completed, Chiesi Farmaceutici S.p.A.; results first posted 2021-12-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects. Trials, record NCT03084718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03084718

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects
NCT number: NCT03084718
Status: Completed
Phases: Phase 2
Enrollment: 610 participants, actual
Lead sponsor: Chiesi Farmaceutici S.p.A.
Conditions: Asthma
Interventions: CHF 718 pMDI, Placebo pMDI, Beclomethasone Dipropionate (BDP)
First posted: 2017-03-21
Last updated: 2021-12-14
Results first posted: 2021-12-14

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Baseline, Week 8	Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;
Secondary	Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Baseline, Week 4	Change from baseline in pre-dose morning FEV1 at Week 4. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;
Secondary	Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline	Baseline, Week 4, Week 8	Change from baseline in pre-dose morning FVC at Week 4 and 8. Spirometry, used to measure FVC, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity;
Secondary	Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline	Baseline, Week 4, Week 8	The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = "totally controlled" and 6 = "severely uncontrolled". The ACQ score was calculated as the average of all 7 items. Definitions: ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second;
Secondary	Average Use of Rescue Medication - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. Definitions: Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Secondary	Percentage (%) of Rescue Medication-free Days - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline. Definitions: Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period. Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Secondary	Overall Daily Asthma Symptoms Scores - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Overall daily asthma symptoms scores - Change From Baseline (am and pm). Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe. Baseline=Averages values during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Secondary	Percentage (%) of Asthma Symptoms-free Days - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Change from baseline in Percentage (%) of asthma symptoms-free days. Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score). Subjects recorded asthma symptom score as described in the Outcome measure #7. Definitions: Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Secondary	Percentage (%) of Asthma Control Days - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use. Definitions: Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Secondary	Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements. Definitions: Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Baseline, Week 8	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	Litres	LEAST_SQUARES_MEAN
SECONDARY	Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Baseline, Week 4	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	Litres	LEAST_SQUARES_MEAN
SECONDARY	Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline	Baseline, Week 4, Week 8	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	Litres	LEAST_SQUARES_MEAN
SECONDARY	Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline	Baseline, Week 4, Week 8	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Average Use of Rescue Medication - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	puffs/day	LEAST_SQUARES_MEAN
SECONDARY	Percentage (%) of Rescue Medication-free Days - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	% of rescue medication-free days	LEAST_SQUARES_MEAN
SECONDARY	Overall Daily Asthma Symptoms Scores - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage (%) of Asthma Symptoms-free Days - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	% of of asthma symptom-free days	LEAST_SQUARES_MEAN
SECONDARY	Percentage (%) of Asthma Control Days - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	% of asthma control days	LEAST_SQUARES_MEAN
SECONDARY	Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)	Intention to treat:~All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.	Liters/min	LEAST_SQUARES_MEAN

1 to 10 of 16Source ClinicalTrials.gov

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Results by group180

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Treatment A (CHF 718 pMDI 100 µg TDD)	0.021	95% Confidence Interval -0.036 to 0.077	Litres
Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Treatment B (CHF 718 pMDI 400 µg TDD)	0.090	95% Confidence Interval 0.033 to 0.147	Litres
Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Treatment C (CHF 718 pMDI 800 µg TDD)	0.070	95% Confidence Interval 0.013 to 0.126	Litres
Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Treatment D (Placebo)	-0.023	95% Confidence Interval -0.079 to 0.033	Litres
Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Treatment E (QVAR^®, 320 µg TDD)	0.078	95% Confidence Interval 0.024 to 0.133	Litres
Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Treatment A (CHF 718 pMDI 100 µg TDD)	0.021	95% Confidence Interval -0.035 to 0.077	Litres
Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Treatment B (CHF 718 pMDI 400 µg TDD)	0.120	95% Confidence Interval 0.064 to 0.177	Litres
Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Treatment C (CHF 718 pMDI 800 µg TDD)	0.073	95% Confidence Interval 0.018 to 0.129	Litres
Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Treatment D (Placebo)	0.003	95% Confidence Interval -0.052 to 0.058	Litres
Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Treatment E (QVAR^®, 320 µg TDD)	0.077	95% Confidence Interval 0.023 to 0.131	Litres

1 to 10 of 180Source ClinicalTrials.gov

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Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment A (CHF 718 pMDI 100 µg TDD)	120
Overall Study	STARTED	Treatment B (CHF 718 pMDI 400 µg TDD)	120
Overall Study	STARTED	Treatment C (CHF 718 pMDI 800 µg TDD)	122
Overall Study	STARTED	Treatment D (Placebo)	124
Overall Study	STARTED	Treatment E (QVAR^® 320 µg TDD)	124
Overall Study	COMPLETED	Treatment A (CHF 718 pMDI 100 µg TDD)	109
Overall Study	COMPLETED	Treatment B (CHF 718 pMDI 400 µg TDD)	110
Overall Study	COMPLETED	Treatment C (CHF 718 pMDI 800 µg TDD)	110
Overall Study	COMPLETED	Treatment D (Placebo)	110
Overall Study	COMPLETED	Treatment E (QVAR^® 320 µg TDD)	120

1 to 10 of 15Source ClinicalTrials.gov

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Adverse events75

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Oral candidiasis	Infections and infestations	Treatment A (CHF 718 pMDI 100 µg TDD)	1	119	1
other	Oral candidiasis	Infections and infestations	Treatment B (CHF 718 pMDI 400 µg TDD)	0	120	0
other	Oral candidiasis	Infections and infestations	Treatment C (CHF 718 pMDI 800 µg TDD)	6	121	6
other	Oral candidiasis	Infections and infestations	Treatment D (Placebo)	0	124	0
other	Oral candidiasis	Infections and infestations	Treatment E (QVAR^®, 320 µg TDD)	4	124	4
other	Upper respiratory tract infection	Infections and infestations	Treatment A (CHF 718 pMDI 100 µg TDD)	6	119	6
other	Upper respiratory tract infection	Infections and infestations	Treatment B (CHF 718 pMDI 400 µg TDD)	2	120	2
other	Upper respiratory tract infection	Infections and infestations	Treatment C (CHF 718 pMDI 800 µg TDD)	3	121	3
other	Upper respiratory tract infection	Infections and infestations	Treatment D (Placebo)	3	124	3
other	Upper respiratory tract infection	Infections and infestations	Treatment E (QVAR^®, 320 µg TDD)	7	124	7

1 to 10 of 75Source ClinicalTrials.gov

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Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment A (CHF 718 pMDI 100 µg TDD)	0	119
Total, all-cause mortality	Treatment B (CHF 718 pMDI 400 µg TDD)	1	120
Total, all-cause mortality	Treatment C (CHF 718 pMDI 800 µg TDD)	0	121
Total, all-cause mortality	Treatment D (Placebo)	0	124
Total, all-cause mortality	Treatment E (QVAR^®, 320 µg TDD)	0	124
Total, other adverse events	Treatment A (CHF 718 pMDI 100 µg TDD)	18	119
Total, other adverse events	Treatment B (CHF 718 pMDI 400 µg TDD)	8	120
Total, other adverse events	Treatment C (CHF 718 pMDI 800 µg TDD)	25	121
Total, other adverse events	Treatment D (Placebo)	28	124
Total, other adverse events	Treatment E (QVAR^®, 320 µg TDD)	21	124

1 to 10 of 15Source ClinicalTrials.gov

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Papers64

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
2001060	BACKGROUND	PubMed
3427176	BACKGROUND	PubMed
8499054	BACKGROUND	PubMed
9840434	BACKGROUND	PubMed
9850359	BACKGROUND	PubMed
10027430	BACKGROUND	PubMed
10573240	BACKGROUND	PubMed
10589004	BACKGROUND	PubMed
11112914	BACKGROUND	PubMed
11266239	BACKGROUND	PubMed

1 to 10 of 64

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Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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