Not yet recruitingNCT07876284Updated Oct 21, 2026

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis

A Phase 1 interventional study of CHF10073 low dose and CHF10073 high dose in Idiopathic Pulmonary Fibrosis, sponsored by Chiesi Farmaceutici S.p.A.. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 1, Interventional, and Other

Updated Oct 21, 2026Primary outcomes revisedNewly registeredGo to Updates ↓

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 40 Years and older
Sex: All

Study summary

The objective of the study is to assess the safety and tolerability of repeated doses of CHF10073 and to characterise cough-related safety outcomes associated with CHF10073 administration. In addition, the study will also characterise the PK (pharmacokinetics) profile in plasma after repeated administrations of study drug.

Conditions studied

Idiopathic Pulmonary Fibrosis

Browse trials for

Idiopathic Pulmonary Fibrosis 565

In context

Idiopathic Pulmonary Fibrosis

565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's planned enrollment of 18 is below the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Chiesi Farmaceutici S.p.A. is the lead sponsor of 185 studies on the registry; 23 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.

Browse Chiesi Farmaceutici S.p.A. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Written informed consent obtained before any study-related procedure.
Male or female participant of any race, aged 40 years or older.
Diagnosis of idiopathic pulmonary fibrosis according to the 2018 and 2022 ATS/ERS/JRS/ALAT Guidelines for no more than 8 years before Screening, confirmed by centrally reviewed high-resolution computed tomography obtained within 12 months before Screening or performed during Screening.
Receiving locally approved idiopathic pulmonary fibrosis monotherapy at a stable dose for at least 8 weeks before Screening, or not receiving such monotherapy, including discontinuation at least 4 weeks before Screening.
Forced vital capacity at least 45% predicted and pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity ratio at least 0.7.
Diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin, at least 25% predicted.
Peripheral oxygen saturation greater than 90% after 5 minutes at rest on room air or with protocol-specified supplemental oxygen.
Ability to correctly use the device after training with placebo.
Nonsmoker or ex-smoker meeting protocol-defined cessation periods and willing to abstain from all inhaled smoking products throughout the study.
Female participant meeting protocol definitions for non-childbearing potential or, if of childbearing potential, meeting pregnancy-testing and contraception requirements.
Male participant meeting protocol-defined fertility and contraception requirements

Exclusion criteria

Exclusion Criteria:

Lower respiratory tract infection requiring antibiotics within 4 weeks before Screening or documented acute exacerbation of idiopathic pulmonary fibrosis within 3 months before Screening.
Planned major surgery during the study or history of lung resection.
Active or prior lung cancer.
Active cancer or cancer history with less than 5 years disease-free survival, except adequately treated localized carcinoma.
Emphysema involving at least 50% of the lung on high-resolution computed tomography or emphysema greater in extent than fibrosis.
End-stage fibrotic disease expected to require organ transplantation within 6 months.
Clinically relevant uncontrolled medical or psychiatric disorders that may interfere with study completion or increase risk.
Other non-idiopathic pulmonary fibrosis pulmonary condition that may affect forced vital capacity.
Body mass index reater than or equal to 35.0 kg/m² or recent excessive unexplained weight loss.
Clinically significant abnormal 12-lead electrocardiogram; corrected QT interval using Fridericia's formula greater than 450 milliseconds for males or greater than 470 milliseconds for females.
Clinically significant cardiovascular condition that would preclude participation.
Significant neurologic disease, including protocol-specified recent transient ischemic attack, stroke, seizure, uncontrolled seizure disorder, or clinically significant behavioral or psychiatric disturbance.
Recent or current systemic corticosteroid, immunosuppressant, cytotoxic therapy, pulmonary hypertension vasodilator therapy, inhaled bronchodilator, or inhaled corticosteroid use within protocol-specified periods.
Concomitant treatment with more than one locally approved idiopathic pulmonary fibrosis therapy.
Participation in another investigational drug trial within 3 months or 5 half-lives of that drug, whichever is longer.
New or unresolved infection within 7 days before Screening or randomization, except respiratory infections addressed separately.
Known intolerance or hypersensitivity to formulation excipients or another substance used in the trial.
Use of non permitted concomitant medication as per protocol.
Clinically relevant abnormal laboratory values requiring investigation or potentially affecting safety or study evaluation.
Positive human immunodeficiency virus type 1 or type 2 test at Screening.
Positive hepatitis test indicating acute or chronic hepatitis B or C at Screening.
Documented alcohol or drug abuse within 12 months before Screening.
Pregnant or lactating female participant.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 18 participants (estimated)

Study arms

Experimental
CHF10073 low dose
Drug: CHF10073 low dose
Experimental
CHF10073 high dose
Drug: CHF10073 high dose
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugCHF10073 low dose
Multiple doses of CHF10073
DrugCHF10073 high dose
Multiple doses of CHF10073
DrugPlacebo
Multiple doses of placebo

What researchers measure

Primary outcomes

Number and % of participants with treatment-emergent adverse events, adverse drug reactions, serious and non-serious events, related and non-related events, severe events, events leading to discontinuation and events leading to death
Time frame: Day 1 through Follow-up visit, 35 to 42 days after the last dose
Change from baseline in systolic and diastolic blood pressure
Time frame: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in pulse rate
Time frame: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in respiratory rate
Time frame: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in body temperature
Time frame: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in oxygen saturation
Time frame: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Number and percentage of participants with a change from baseline greater than 20 mmHg in systolic blood pressure and greater than 10 mmHg in diastolic blood pressure.
Time frame: Day 1 through Follow-up visit, 35 to 42 days after the last dose
Change from baseline in ECG heart rate
Time frame: Day 1, Day 14 and Day 28 at pre-dose and at 3 hours post-dose (up to Follow-up visit, 35 to 42 days after the last dose for UK)
Change from baseline in ECG intervals: PR interval and QT interval corrected using Fridericia's formula.
Time frame: Day 1, Day 14 and Day 28 at pre-dose and at 3 hours post-dose (up to Follow-up visit, 35 to 42 days after the last dose for UK)
Change from baseline in ECG: QRS duration
Time frame: Day 1, Day 14 and Day 28 at pre-dose and at 3 hours post-dose (up to Follow-up visit, 35 to 42 days after the last dose for UK)
Number and percentage of participants with an increase from baseline in QT interval corrected using Fridericia's formula greater than 30 milliseconds and greater than 60 milliseconds.
Time frame: Day 1 through Day 28 (up to Follow-up visit, 35 to 42 days after the last dose for UK)
Number and percentage of male participants with post-dose QT interval corrected using Fridericia's formula greater than 450, 480, and 500 milliseconds and female participants with values greater than 470 and 500 milliseconds
Time frame: Day 1 through Day 28 (up to Follow-up visit, 35 to 42 days after the last dose for UK)
Change and shift from baseline in clinical chemistry, including fasting glucose, and hematology evaluations
Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics.
Time frame: Day 1, Day 14 and Day 28 at pre-dose
Change from baseline in forced vital capacity and forced expiratory volume in 1 second.
Time frame: Day 1 , Day 14 and Day 28 at pre-dose and 30 minutes post-dose

Secondary outcomes

Number and percentage of participants experiencing cough treatment-emergent adverse events
Time frame: Day 1 through Follow-up visit, 35 to 42 days after the last dose
Plasma pharmacokinetic parameter AUC0-t for CHF10073.
Time frame: Day 1 and Day 28
Maximum observed plasma concentration (Cmax) of CHF10073.
Time frame: Day 1 and Day 28
Time to reach maximum observed plasma concentration (tmax) of CHF10073
Time frame: Day 1 and Day 28
Dose proportionality assessment using dose-normalized, log-transformed AUC0-t and Cmax as applicable.
Time frame: Day 1 and Day 28
Plasma concentration-time profiles summarized by dose level and study day
Time frame: Day 1, Day 14, Day 28, and Follow-up, 35 to 42 days after the last dose

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No — Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.

No publications or documents are linked to this record.

Timeline

2 registry updates since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.

Of 58 industry-sponsored phase 1 interventional studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 9 months is close to that.

Counting every sponsor, half of 73 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 9, 2026
First posted: Oct 15, 2026
StartEst.: Nov 2026
Primary completionEst.: Aug 2027
CompletionEst.: Aug 2027
Last update: Oct 21, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Also revised

primary outcomes

Registered

First appeared on the registry

Oct 15, 2026

Show all 2 updates

Oct 21, 2026
Primary outcomes Revised (7 changes)
+ 1 other change: secondary outcomes
Oct 15, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07876284
Lead sponsor: Chiesi Farmaceutici S.p.A.
Responsible party: Sponsor
First posted: Oct 15, 2026
Start date: Nov 2026 (estimated)
Primary completion: Aug 2027 (estimated)
Completion: Aug 2027 (estimated)
Last update: Oct 21, 2026

Study contacts

Chiesi Clinical Trial info

Contact

clinicaltrials_info@chiesi.com

+39 0521 2791

Pilar Rivera Ortega, MD

principal investigator · Royal Devon and Exeter Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Idiopathic Pulmonary Fibrosis →

Other studies from this sponsor

Chiesi Farmaceutici S.p.A. →

Start the discussion