AsthmaPhase 1NCT05830071

A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)

A Phase 1 study testing CHF5993, CHF5259 and Moxifloxacin 400mg in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the potential for cardiac repolarization, according to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of CHF5993 pMDI (beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB)) and of one dose of CHF5259 (GB) in… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: CHF5993, CHF5259 and Moxifloxacin 400mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 1 siteUnited States
Study dates: 29 Mar 2023to 13 Oct 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject's written informed consent;
18-55 years of age;
Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly;
Body Mass Index (BMI) between 18 and 32 kg/m2 extremes inclusive;
Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year prior to screening;
Good physical and mental status, determined on the basis of the medical history and a general clinical examination;

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Vital signs within normal limits at screening and prior to randomization: Diastolic BP 40-89 mmHg, Systolic BP 90-139 mmHg extremes included (mean value of three measures). Body temperature < 37.5°C;
12 -lead digitized Electrocardiogram (12-lead ECG) in triplicate considered as normal (40 ≤ Heart rate ≤ 110bpm, 120 ms ≤ PR ≤ 220 ms, QRS ≤ 110 ms, QTcF ≤ 450 ms);
Lung function measurements within normal limits (normal values: forced expiratory volume in the 1st second [FEV1]/forced vital capacity [FVC] > 0.70 and FEV1 > 80% predicted);
Female subjects of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods.

Who cannot join

Participation in another clinical trial where investigational drug was received and last investigations within the last 8 weeks;
Clinically significant abnormal standard ECG at screening;
Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with successful completion of this protocol;
Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic;
Subjects with history of breathing problems (i.e., history of asthma including childhood asthma);
Positive urine test for cotinine;

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Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to randomization, or the subject is expected to take non-permitted concomitant medications during the study;
Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or to randomization;
Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;
Women who are pregnant or lactating;
Use of any kind of smoking electronic devices within 6 months before Screening.
Other inclusion/exclusion criteria as defined by the protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

PAREXEL Baltimore Early Phase Clinical Unit
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Positive and Placebo-controlled, Single-dose, Crossover Study of the Effects of CHF5993 pMDI (BDP/FF/GB) at the Proposed Therapeutic and Supratherapeutic Doses, on the Cardiovascular Safety in Healthy Subjects

Read the detailed description

The main purpose of this study is to evaluate the effect of a single supratherapeutic dose of inhaled BDP/FF/GB on cardiovascular safety. The secondary purposes of the study are to: 1) evaluate the effect of a single supratherapeutic dose of inhaled BDP/FF/GB and GB on cardiovascular safety; 2) establish assay sensitivity by demonstrating the effect of a single oral dose of 400 mg moxifloxacin on cardiovascular safety; 3) determine the pharmacokinetics (PK) of single, inhaled therapeutic and supratherapeutic BDP/FF/GB doses and supratherapeutic GB dose; 4) determine if there is a relationship between the duration of the QTc intervals and the plasma concentrations of the B17MP (beclomethasone 17monopropionate active metabolite of BDP), FF and GB following the administration of BDP/FF/GB and GB pMDIs; 5) generate additional safety and tolerability information.

Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Being tested: CHF5993, CHF5259, Moxifloxacin 400mg, CHF5993 Placebo
Medical subject headings: Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHF5993Drug
Also called beclometasone dipropionate /formoterol fumarate/glycopyrronium bromide, BDP/FF/GB
BDP/FF/GB 100/6/12.5 μg pMDI
CHF5259Drug
Also called glycopyrronium bromide, GB
GB 12.5 μg pMDI
Moxifloxacin 400mgDrug
Also called Moxifloxacin hydrochloride
400 mg Oral Tablets
CHF5993 PlaceboDrug
Also called BDP/FF/GB Placebo
placebo pMDI

Study groups in NCT05830071
Study group	Role	What they receive
Single therapeutic dose of CHF5993 (BDP/FF/GB)	Experimental	Dose: BDP/FF/GB 100/6/12.5 μg, single dose inhalation via pressurized metered dose inhaler (2 puffs from 1 BDP/FF/GB 100/6/12.5 μg pMDI + 2 puffs from 3 placebo pMDI) Receives: Drug: CHF5993; Drug: CHF5993 Placebo
Single supra-therapeutic dose of CHF5993 (BDP/FF/GB)	Experimental	Dose: BDP/FF/GB 800/48/100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 BDP/FF/GB 100/6/12.5 μg pMDI) Receives: Drug: CHF5993
Single supra-therapeutic dose CHF5259 (GB)	Experimental	Dose: GB 100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 GB 12.5 μg pMDI) Receives: Drug: CHF5259
Single dose Placebo	Placebo comparator	Dose: placebo single dose inhalation, via pressurized metered dose inhaler 8 puffs from 4 CHF5993 placebo pMDI Receives: Drug: CHF5993 Placebo
Moxifloxacin	Active comparator	Dose: moxifloxacin 400 mg single dose, for oral use - open label treatment (1 tablet of moxifloxacin 400 mg PO) Receives: Drug: Moxifloxacin 400mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of BDP/FF/GB pMDI at therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Placebo-adjusted change in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (200/12/25 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours

Secondary outcomes (21)

Effect of BDP/FF/GB pMDI and GB pMDI at supra-therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Placebo-adjusted change from baseline in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours
Assay sensitivity by demonstrating the effect of a single oral therapeutic dose of moxifloxacin on QTcF.
Placebo-adjusted change from baseline in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG
Measured: time 0 (pre-dose) to 6 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on Hearth Rate (HR).
Placebo-adjusted change from baseline of HR (ΔΔHR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on PR interval (PR).
Placebo-adjusted change from baseline of PR (ΔΔPR) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on QRS interval (QRS).
Placebo-adjusted change from baseline of QRS (ΔΔQRS) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg) will be summarized by means of descriptive statistics at each analysis time point and by treatment. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on individual-corrected QT interval (QTcI)
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours
Effect of moxifloxacin at therapeutic dose on individual-corrected QT interval.
Placebo-adjusted change from baseline in individual-corrected QT interval (ΔΔQTcI) after dosing 400 mg of moxifloxacin. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 6 hours
Changes in T-wave morphology and U-wave presence.
Frequency of treatment-emergent changes in T-wave morphology and U-wave presence after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours
Analysis of categorical outliers of Hearth Rate (HR), PR interval (PR), QRS interval (QRS) and QTcF interval (QTcF), after BDP/FF/GB pMDI dosing at therapeutic and supra-therapeutic dose, and after GB dosing at supra-therapeutic dose.
Results of categorical outliers will be summarized by treatment in frequency tables reporting: counts and percentages for number of subjects and number of time points with 1) abnormal actual QTcF values, and 2) abnormal change from baseline of HR, PR, QRS and QTcF. Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.
Measured: time 0 (pre-dose) to 24 hours
Analysis of Maximum plasma concentration (Cmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of Cmax after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Measured: time 0 (pre-dose) to 24 hours
Analysis of Area under the curve from 0 to 12 hours post-dose (AUC0-12), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of AUC0-12, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Measured: time 0 (pre-dose) to 24 hours
Analysis of Area under the plasma concentration-time curve from time 0 to time t (AUC0 t), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of AUC0-t after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Measured: time 0 (pre-dose) to 24 hours
Analysis of Area under the curve from time 0 to infinity (AUC0-∞), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of AUC0-∞ after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Measured: time 0 (pre-dose) to 24 hours
Analysis of Time to maximum plasma concentration (tmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of tmax, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Measured: time 0 (pre-dose) to 24 hours
Analysis of Terminal half-life (t1/2), pharmacokinetic parameter of FF, GB, BDP and B17MP
Analysis of t1/2, after dosing BDP/FF/GB pMDI (200/12/25 μg and 800/48/100 μg) and GB pMDI (100 μg).
Measured: time 0 (pre-dose) to 24 hours
Incidence of Adverse events
Number and percentage of subjects with at least one event and number of treatment emergent events
Measured: from study start through study completion, an average of 4 months
Incidence of Adverse Drug Reactions
Number and percentage of subjects with at least one event and number of treatment emergent events
Measured: from study start through study completion, an average of 4 months
Change of systolic and diastolic blood pressure
Number and percentage of subjects with with abnormal changes from baseline
Measured: from study start through study completion, an average of 4 months
Body temperature abnormal values
Number and percentage of subjects with at least one event and number of treatment emergent events
Measured: from study start through study completion, an average of 4 months
Abnormal results of physical examinations
Number and percentage of subjects with at least one event and number of treatment emergent events
Measured: from study start through study completion, an average of 4 months
Abnormal clinical chemistry and haematology laboratory tests
Number and percentage of subjects with at least one event and number of treatment emergent events
Measured: from study start through study completion, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 202313 Oct 2023

First posted26 Apr 2023
Study start29 Mar 2023
Primary completion13 Oct 2023
Study completion13 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05830071
Sponsor's protocol ID: CLI-05993AB7-03
Status last verified: Sep 2024
First submitted: 28 Mar 2023
Last updated: 4 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Positive and Placebo-controlled, Single-dose, Crossover Study of the Effects of CHF5993 pMDI (BDP/FF/GB) at the Proposed Therapeutic and Supratherapeutic Doses, on the Cardiovascular Safety in Healthy Subjects
ClinicalTrials.gov ID: NCT05830071
Acronym / sponsor ID: CLI-05993AB7-03
Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
Study start: 29 Mar 2023 (actual)
Primary completion: 13 Oct 2023 (actual)
Study completion: 13 Oct 2023 (actual)
First posted: 26 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Single therapeutic dose of CHF5993 (BDP/FF/GB)	Experimental	Drug: CHF5993, Drug: CHF5993 PlaceboDose: BDP/FF/GB 100/6/12.5 μg, single dose inhalation via pressurized metered dose inhaler (2 puffs from 1 BDP/FF/GB 100/6/12.5 μg pMDI + 2 puffs from 3 placebo pMDI)
Single supra-therapeutic dose of CHF5993 (BDP/FF/GB)	Experimental	Drug: CHF5993Dose: BDP/FF/GB 800/48/100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 BDP/FF/GB 100/6/12.5 μg pMDI)
Single supra-therapeutic dose CHF5259 (GB)	Experimental	Drug: CHF5259Dose: GB 100 μg single dose inhalation, via pressurized metered dose inhaler (8 puffs from 4 GB 12.5 μg pMDI)
Single dose Placebo	Placebo comparator	Drug: CHF5993 PlaceboDose: placebo single dose inhalation, via pressurized metered dose inhaler 8 puffs from 4 CHF5993 placebo pMDI
Moxifloxacin	Active comparator	Drug: Moxifloxacin 400mgDose: moxifloxacin 400 mg single dose, for oral use - open label treatment (1 tablet of moxifloxacin 400 mg PO)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Subject's written informed consent;
18-55 years of age;
Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly;
Body Mass Index (BMI) between 18 and 32 kg/m2 extremes inclusive;
Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year prior to screening;

Key exclusion criteria (12 listed)

Participation in another clinical trial where investigational drug was received and last investigations within the last 8 weeks;
Clinically significant abnormal standard ECG at screening;
Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with successful completion of this protocol;
Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic;
Subjects with history of breathing problems (i.e., history of asthma including childhood asthma);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHF5993Also: beclometasone dipropionate /formoterol fumarate/glycopyrronium bromide, BDP/FF/GBBDP/FF/GB 100/6/12.5 μg pMDI	Drug	Single supra-therapeutic dose of CHF5993 (BDP/FF/GB), Single therapeutic dose of CHF5993 (BDP/FF/GB)
CHF5259Also: glycopyrronium bromide, GBGB 12.5 μg pMDI	Drug	Single supra-therapeutic dose CHF5259 (GB)
Moxifloxacin 400mgAlso: Moxifloxacin hydrochloride400 mg Oral Tablets	Drug	Moxifloxacin
CHF5993 PlaceboAlso: BDP/FF/GB Placeboplacebo pMDI	Drug	Single dose Placebo, Single therapeutic dose of CHF5993 (BDP/FF/GB)

Primary outcome

Effect of BDP/FF/GB pMDI at therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Time frame: time 0 (pre-dose) to 24 hours
Placebo-adjusted change in QTc interval based on the Fridericia's correction (ΔΔQTcF) after dosing CHF5993 pMDI (200/12/25 μg). Through digitised 12-lead ECG, extracted from 12-Lead Holter ECG.

21 secondary outcomes

Effect of BDP/FF/GB pMDI and GB pMDI at supra-therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF).
Time frame: time 0 (pre-dose) to 24 hours
Assay sensitivity by demonstrating the effect of a single oral therapeutic dose of moxifloxacin on QTcF.
Time frame: time 0 (pre-dose) to 6 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on Hearth Rate (HR).
Time frame: time 0 (pre-dose) to 24 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on PR interval (PR).
Time frame: time 0 (pre-dose) to 24 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on QRS interval (QRS).
Time frame: time 0 (pre-dose) to 24 hours
Effect of BDP/FF/GB pMDI at therapeutic and supra-therapeutic dose and of GB pMDI at supra-therapeutic dose on individual-corrected QT interval (QTcI)
Time frame: time 0 (pre-dose) to 24 hours
Effect of moxifloxacin at therapeutic dose on individual-corrected QT interval.
Time frame: time 0 (pre-dose) to 6 hours
Changes in T-wave morphology and U-wave presence.
Time frame: time 0 (pre-dose) to 24 hours
Analysis of categorical outliers of Hearth Rate (HR), PR interval (PR), QRS interval (QRS) and QTcF interval (QTcF), after BDP/FF/GB pMDI dosing at therapeutic and supra-therapeutic dose, and after GB dosing at supra-therapeutic dose.
Time frame: time 0 (pre-dose) to 24 hours
Analysis of Maximum plasma concentration (Cmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Time frame: time 0 (pre-dose) to 24 hours
Analysis of Area under the curve from 0 to 12 hours post-dose (AUC0-12), pharmacokinetic parameter of FF, GB, BDP and B17MP
Time frame: time 0 (pre-dose) to 24 hours
Analysis of Area under the plasma concentration-time curve from time 0 to time t (AUC0 t), pharmacokinetic parameter of FF, GB, BDP and B17MP
Time frame: time 0 (pre-dose) to 24 hours
Analysis of Area under the curve from time 0 to infinity (AUC0-∞), pharmacokinetic parameter of FF, GB, BDP and B17MP
Time frame: time 0 (pre-dose) to 24 hours
Analysis of Time to maximum plasma concentration (tmax), pharmacokinetic parameter of FF, GB, BDP and B17MP
Time frame: time 0 (pre-dose) to 24 hours
Analysis of Terminal half-life (t1/2), pharmacokinetic parameter of FF, GB, BDP and B17MP
Time frame: time 0 (pre-dose) to 24 hours
Incidence of Adverse events
Time frame: from study start through study completion, an average of 4 months
Incidence of Adverse Drug Reactions
Time frame: from study start through study completion, an average of 4 months
Change of systolic and diastolic blood pressure
Time frame: from study start through study completion, an average of 4 months
Body temperature abnormal values
Time frame: from study start through study completion, an average of 4 months
Abnormal results of physical examinations
Time frame: from study start through study completion, an average of 4 months
Abnormal clinical chemistry and haematology laboratory tests
Time frame: from study start through study completion, an average of 4 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ronald Goldwater, MDCM/M.SC(A) principal investigator

PAREXEL Baltimore Early Phase Clinical Unit

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CHF5993, CHF5259 and Moxifloxacin 400mg in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of BDP/FF/GB pMDI at therapeutic dose on the heart rate-corrected QT interval based on the Fridericia's correction (QTcF). (time frame: time 0 (pre-dose) to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05830071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.