AsthmaPhase 2FLASHNCT03086460

A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)

A Phase 2 study testing CHF 1531 pMDI and Formoterol Inhalation Solution in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 10 sites 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

To evaluate the dose-response of different doses of CHF 1531 pressurized metered dose inhaler (pMDI) containing formoterol fumarate, on lung function and other clinical outcomes and to identify the optimal dose(s) with regard to benefit/ risk ratio for further development in the target subject population. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Asthma
What is being tested?: CHF 1531 pMDI and Formoterol Inhalation Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 10 sitesUnited States
Study dates: 8 Sep 2017to 28 Jul 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent Form prior to initiation of any study-related procedure.
A diagnosis of asthma as defined in the Global Initiative for Asthma (GINA) Report, 2016, documented for at least 1 year prior to screening.
Poorly controlled or uncontrolled asthma evidenced by a score ≥1.5 on the Asthma Control Questionnaire 7 © (ACQ-7)
A pre-bronchodilator Forced Expiratory Volume in the 1st Second ( FEV1) ≥60% and <85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits
Subjects with a positive response to a reversibility test at screening, defined as change in FEV1 (ΔFEV1) ≥12% and ≥200 mL over baseline within 30 minutes after inhaling 4 puffs of albuterol hydrofluoroalkane(HFA) 90 µg/actuation.
Use of ICS (low/medium dose according to GINA Report, 2016) with or without a long-acting bronchodilator for 3 months (at a stable dose in the last 4 weeks) before screening visit.
A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhaler.

Who cannot join

Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS they are willing to use a highly effective birth control methods
Subjects who suffer from Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Strategy for Prevention, Diagnosis and Management of COPD (GOLD) Report, 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as described in the GINA Report, 2016.
Inability to carry out pulmonary function testing, to comply with study procedures or with study drug intake.
Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of >10 pack-years or having stopped smoking one year or less prior to screening visit.
History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
An asthma exacerbation requiring oral/intravenous corticosteroids ≤ 30 days, intramuscular depot corticosteroid ≤3 months or hospitalization within 6 months prior to screening.

Show all 21Show fewer

Subjects with unresolved bacterial or viral respiratory tract, sinus, or middle ear infection affecting asthma status within 2 weeks prior to screening.
Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
Subjects with oral candidiasis at screening and at randomization.
Subjects with any clinically significant, uncontrolled condition.
Subjects with serum potassium levels <3.5 milliequivalents per litre (mEq/L) or (3.5 mmol/L) at screening.
Subjects who have clinically significant cardiovascular condition.
Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the patient according to Investigator's judgment.
Subjects whose 12-lead ECG shows Fridericia's corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females at screening or randomization visits.
Subjects with known intolerance/hypersensitivity or contra-indication to treatment with inhaled β2-adrenergic receptor agonists, corticosteroids or propellant gases/excipients.
Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti- Immunoglobulin E (IgE), anti-Interleukin 5 (IL5) or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
Use of potent cytochrome P450 3A4 inhibitors and inducers within 4 weeks prior to screening.
History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
Subjects who are mentally or legally incapacitated or subjects accommodated in an establishment as a result of an official or judicial order.
Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Chiesi Investigational Site
Greenville, South Carolina, 29615
Chiesi Investigational Site
Knoxville, Tennessee, 37909
Chiesi Investigational Site
Los Angeles, California, 90048
Chiesi Investigational Site
Lutherville, Maryland, 21093
Chiesi Investigational Site
Orangeburg, South Carolina, 29118
Chiesi Investigational Site
Raleigh, North Carolina, 27607
Chiesi Investigational Site
Richland, Washington, 99352
Chiesi Investigational Site
Spartanburg, South Carolina, 29303
Chiesi Investigational Site
St Louis, Missouri, 63141
Chiesi Investigational Site
Tucson, Arizona, 85710

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo and Active-controlled, Incomplete Block Cross-over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects

Read the detailed description

This is a phase II, randomized, double-blind, placebo and active controlled dose-ranging, 6 arm incomplete block cross-over study to identify the optimal dose of CHF 1531 pMDI (containing formoterol fumarate), with regard to lung function and other clinical efficacy and safety outcome measures.

After a 2 week run-in period under rescue albuterol 'as needed' and background inhaled corticosteroid (ICS), subjects qualifying for the study were required to complete 4 treatment intervals of 2 weeks each, separated by 2 week wash-out intervals.

During each treatment interval, the subject were randomly assigned to take one of 5 double-blind study treatments twice daily (BID) i.e. one of 4 doses of CHF 1531 pMDI or a matching placebo or the open-label active control treatment (Perforomist® Inhalation Solution [IS]) also BID. During the entire study, all subjects concomitantly received ICS treatment with QVAR® inhaler (beclomethasone dipropionate 40 or 80 µg /actuation) twice daily at a dose that matches their pre-enrollment ICS and an albuterol inhaler to use as asthma rescue medication on 'as needed' basis. The subjects visited the study center every 2 weeks to undergo study procedures, and received a safety follow-up phone call one week after their last visit. In total, the study lasted 18 weeks and required 10 visits to the study center.

During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication were recorded in a subject diary. Treatment-Emergent Adverse Events (TEAEs) were assessed and recorded throughout the study. A full physical exam, routine hematology, blood chemistry, spirometry, vital signs measurement, 12-lead ECG, and pregnancy testing were performed before enrollment and at the end of the study. Furthermore, on Day 1 and 14 of each treatment interval, serial spirometry, 12-lead ECGs, blood pressure measurements (BP), serum potassium, and serum glucose were measured at the study center for up to 12 hours post-dose.

Conditions: Asthma
Being tested: CHF 1531 pMDI, Formoterol Inhalation Solution, Placebo pMDI
Medical subject headings: Asthma

What participants receive

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

CHF 1531 pMDIDrug
Dose Response: Test one of five different doses of CHF 1531
Formoterol Inhalation SolutionDrug
Also called PERFOROMIST® 20 μg/ 2 mL vial, 1 vial BID
Active Control
Placebo pMDIDrug
Matched Placebo

Study groups in NCT03086460
Study group	Role	What they receive
Treatment A	Experimental	Treatment A, CHF 1531 pMDI: CHF 1531 pMDI 6 μg total daily dose (TDD): 1 inhalation of CHF 1531 pMDI 3 μg/actuation plus 1 inhalation of CHF 1531 matched Placebo BID. Receives: Drug: CHF 1531 pMDI
Treatment B	Experimental	Treatment B, CHF 1531 pMDI: CHF 1531 pMDI 12 μg TDD: 1 inhalation of CHF 1531 pMDI 6 μg/actuation plus 1 inhalation of CHF 1531 matched Placebo BID. Receives: Drug: CHF 1531 pMDI
Treatment C	Experimental	Treatment C, CHF 1531 pMDI: CHF 1531 pMDI 24 μg TDD: 2 inhalations of CHF 1531 pMDI 6 μg/actuation BID. Receives: Drug: CHF 1531 pMDI
Treatment D	Experimental	Treatment D, CHF 1531 pMDI CHF 1531 pMDI 48 μg TDD: 2 inhalations of CHF 1531 pMDI 12 μg/actuation BID. Receives: Drug: CHF 1531 pMDI
Treatment E	Experimental	Treatment E, Matched placebo Placebo: 2 inhalations of CHF 1531 pMDI matched Placebo BID. Receives: Drug: Placebo pMDI
Treatment F	Active comparator	Treatment F, Formoterol fumarate inhalation solution (IS) Perforomist® IS (active comparator, open-label) 40 μg TDD: 1 inhalation, 20 μg/ 2 mL vial, 1 vial BID. Receives: Drug: Formoterol Inhalation Solution

What is being measured

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

FEV1 Area Under the Curve Between 0 and 12 h [AUC(0-12h)], Normalized by Time -- Change From Baseline to Post Dose Day 14
Spirometry used to measure FEV1, was performed according to internationally accepted standards. Results show the change from baseline in FEV1 AUC(0-12h), normalized by time on Day 14; it was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Definitions:
AUC=Area under the curve; AUC(0-12h)=AUC between 0 and 12 h; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period; FEV1=Forced expiratory volume in the 1st second;
Measured: Baseline, Day 14 post-dose
Sensitivity Analysis 1: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14
The primary analysis was repeated, considering patients "as randomized" and including only the first instance of each treatment.
Patients receiving the same treatment in more than one period were included in the analysis with only data from the first instance of each treatment.
Measured: Baseline, Day 14 post-dose
Sensitivity Analysis 2: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14
The primary analysis was repeated, considering only patients and treatment periods for which treatment was assigned on or after the randomization error occurred.
The number of patients shown represents those with at least one post-baseline assessment available.
Measured: Baseline, Day 14 post-dose
Sensitivity Analysis 3: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14
Patients receiving the same treatment during two treatment periods are considered twice in the ANCOVA model (once for each period attended).
Patients considered in this analysis are those with at least one available post-baseline assessment.
Measured: Baseline, Day 14 post-dose

Secondary outcomes (20)

FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 1
Spirometry used to measure FEV1, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 1 post-dose
FEV1 AUC(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Spirometry used to measure FEV1, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 1, Day 14 post-dose
FEV1 Peak(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Spirometry, used to measure FEV1, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 1, Day 14 post-dose
FVC AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Spirometry, used to measure FVC, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 1, Day 14 post-dose
FVC AUC(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Spirometry, used to measure FVC, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 1, Day 14 post-dose
FVC Peak(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Spirometry, used to measure FVC, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 1, Day 14 post-dose
Pre-dose Morning FEV1 (L) -- Change From Baseline to Post Dose Day 14
Spirometry, used to measure FEV1, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 14 post-dose
Pre-dose Morning FVC -- Change From Baseline to Post Dose Day 14
Spirometry, used to measure FVC, was performed according to internationally accepted standards.
Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).
Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 14 post-dose
Time to Onset of Action -- Change From Baseline in Post-dose FEV1 ≥12% and ≥200 mL to Post Dose Day 1
Spirometry, used to measure FEV1, was performed according to internationally accepted standards.
For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment.
Definitions:
Time to onset of action=The time (in minutes) from receiving the study drug on Day 1, until the FEV1 change from baseline is ≥200 mL; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;
Measured: Baseline, Day 1 post-dose
Patients Achieving Onset of Action -- Change From Baseline in Post-dose FEV1 ≥12% and ≥200 mL to Post Dose Day 1
Patients achieving onset of action, defined as a change from baseline in post-dose FEV1 ≥12% and ≥200 mL, on Day 1. These are the subjects who contributed to the results, reported as median and 95% CI for 'Time to onset of action' presented in the Outcome Measure 13, above.
For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment.
Definitions:
Onset of action=Change from baseline in post-dose FEV1 ≥12% and ≥200 mL; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose);
Measured: Baseline, Day 1 post-dose
Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) -- Change From Baseline for Post-dose on Day 1 and on Day 14
Vital signs -- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) were measured at pre-specified times (at baseline - pre dose and on Day 14 of each treatment period or on the day of early study termination).
Results are shown by treatment group, as change from baseline (in mmHg).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
Definitions:
For safety variables, the baseline for each treatment period was defined as pre-dose measurements on Day 1 of each treatment period; Day 14=The day of the last dosing of a treatment period. Day 14 of the second, third, and fourth treatment periods (day of last dosing); treatments were separated by a 2-week wash-out interval;
Measured: Baseline, Day 1 and Day 14 post-dose
12-lead ECG Parameter -- Heart Rate (HR) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Results are shown by treatment group, as change from baseline (in bpm).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Measured: Baseline, Day 1, Day 14 post-dose
Heart Rate (HR) AUC(0-4h), Normalized by Time -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Heart rate HR AUC(0-4h) normalized by time. Results are shown by treatment group, as change from baseline (in bpm).
The HR AUC(0-4h) normalized by time is calculated based on the actual times, using the linear trapezoidal rule.
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Measured: Baseline, Day 1, Day 14 post-dose
Heart Rate (HR) Peak(0-4h), Normalized by Time -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Heart rate (HR) peak(0-4h) normalized by time.
Results are shown by treatment group, as change from baseline (in bpm).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Definitions:
HR=Heart rate; HR peak(0-4h)=The maximum observed value over 4 hours following dosing;
Measured: Baseline, Day 1, Day 14 post-dose
Heart Rate (HR) AUC(0-4h) and Peak(0-4h), Normalized by Time -- Change From Pre-dose to Post Dose Day 14
Heart rate (HR) AUC(0-4h) and HR peak(0-4h), normalized by time (in bpm).
Results are shown as change from pre-dose on Day 14 (in bpm).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
Definitions:
HR=Heart rate; HR AUC(0-4h)=Area under the curve between 0 and 4 h for heart rate; HR peak(0-4h)=The maximum observed value over 4 h after dosing;
Measured: Baseline, Day 14 post-dose
12-lead Electrocardiogram (ECG) Parameter (QTcF Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Measured: Baseline, Day 1, Day 14 post-dose
12-lead Electrocardiogram (ECG) Parameter (PR Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Measured: Baseline, Day 1, Day 14 post-dose
12-lead Electrocardiogram (ECG) Parameter (QRS Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Measured: Baseline, Day 1, Day 14 post-dose
Serum Potassium -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Serum potassium level was monitored during the study. Results are shown by treatment group, as change from baseline (in mmol/L).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Measured: Baseline, Day 1, Day 14 post-dose
Serum Glucose -- Change From Baseline to Post-dose Day 1 and Day 14
Serum glucose level was monitored during the study. Results are shown by treatment group, as change from baseline (in mmol/L).
For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.
For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.
Measured: Baseline, Day 1, Day 14 post-dose

Timeline

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

8 Sep 201728 Jul 2018

First posted22 Mar 2017
Study start8 Sep 2017
Primary completion23 Jul 2018
Study completion28 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (67)Papers the sponsor has linked to this study.
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 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03086460
Sponsor's protocol ID: CCD-05993AA3-03
Acronym: FLASH
Status last verified: Jul 2021
First submitted: 16 Mar 2017
Last updated: 16 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.
PubMed 23245604
Tilert T, Dillon C, Paulose-Ram R, Hnizdo E, Doney B. Estimating the U.S. prevalence of chronic obstructive pulmonary disease using pre- and post-bronchodilator spirometry: the National Health and Nutrition Examination Survey (NHANES) 2007-2010. Respir Res. 2013 Oct 9;14(1):103. doi: 10.1186/1465-9921-14-103.
PubMed 24107140
Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest. 2002 May;121(5 Suppl):121S-126S. doi: 10.1378/chest.121.5_suppl.121s.
PubMed 12010839
Tonnesen P. Smoking cessation and COPD. Eur Respir Rev. 2013 Mar 1;22(127):37-43. doi: 10.1183/09059180.00007212.
PubMed 23457163
van Eerd EA, van der Meer RM, van Schayck OC, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Aug 20;2016(8):CD010744. doi: 10.1002/14651858.CD010744.pub2.
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Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;2013(10):CD010177. doi: 10.1002/14651858.CD010177.pub2.
PubMed 24127118
McGarvey L, Niewoehner D, Magder S, Sachs P, Tetzlaff K, Hamilton A, Korducki L, Bothner U, Vogelmeier C, Koch A, Ferguson GT. One-Year Safety of Olodaterol Once Daily via Respimat(R) in Patients with GOLD 2-4 Chronic Obstructive Pulmonary Disease: Results of a Pre-Specified Pooled Analysis. COPD. 2015;12(5):484-93. doi: 10.3109/15412555.2014.991864. Epub 2015 Feb 18.
PubMed 25692310
Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.
PubMed 20522841
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PubMed 22217233
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PubMed 15764761
Kesten S, Casaburi R, Kukafka D, Cooper CB. Improvement in self-reported exercise participation with the combination of tiotropium and rehabilitative exercise training in COPD patients. Int J Chron Obstruct Pulmon Dis. 2008;3(1):127-36. doi: 10.2147/copd.s2389.
PubMed 18488436
Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009285. doi: 10.1002/14651858.CD009285.pub2.
PubMed 22786525
Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.
PubMed 27181606
Yang IA, Clarke MS, Sim EH, Fong KM. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD002991. doi: 10.1002/14651858.CD002991.pub3.
PubMed 22786484
Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014 Mar 10;2014(3):CD010115. doi: 10.1002/14651858.CD010115.pub2.
PubMed 24615270

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?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
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Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo and Active-controlled, Incomplete Block Cross-over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects
ClinicalTrials.gov ID: NCT03086460
Acronym / sponsor ID: FLASH / CCD-05993AA3-03
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
Study start: 8 Sep 2017 (actual)
Primary completion: 23 Jul 2018 (actual)
Study completion: 28 Jul 2018 (actual)
First posted: 22 Mar 2017 (actual)
Results: Posted 16 Aug 2021

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Treatment A	Experimental	Drug: CHF 1531 pMDITreatment A, CHF 1531 pMDI: CHF 1531 pMDI 6 μg total daily dose (TDD): 1 inhalation of CHF 1531 pMDI 3 μg/actuation plus 1 inhalation of CHF 1531 matched Placebo BID.
Treatment B	Experimental	Drug: CHF 1531 pMDITreatment B, CHF 1531 pMDI: CHF 1531 pMDI 12 μg TDD: 1 inhalation of CHF 1531 pMDI 6 μg/actuation plus 1 inhalation of CHF 1531 matched Placebo BID.
Treatment C	Experimental	Drug: CHF 1531 pMDITreatment C, CHF 1531 pMDI: CHF 1531 pMDI 24 μg TDD: 2 inhalations of CHF 1531 pMDI 6 μg/actuation BID.
Treatment D	Experimental	Drug: CHF 1531 pMDITreatment D, CHF 1531 pMDI CHF 1531 pMDI 48 μg TDD: 2 inhalations of CHF 1531 pMDI 12 μg/actuation BID.
Treatment E	Experimental	Drug: Placebo pMDITreatment E, Matched placebo Placebo: 2 inhalations of CHF 1531 pMDI matched Placebo BID.
Treatment F	Active comparator	Drug: Formoterol Inhalation SolutionTreatment F, Formoterol fumarate inhalation solution (IS) Perforomist® IS (active comparator, open-label) 40 μg TDD: 1 inhalation, 20 μg/ 2 mL vial, 1 vial BID.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent Form prior to initiation of any study-related procedure.
A diagnosis of asthma as defined in the Global Initiative for Asthma (GINA) Report, 2016, documented for at least 1 year prior to screening.
Poorly controlled or uncontrolled asthma evidenced by a score ≥1.5 on the Asthma Control Questionnaire 7 © (ACQ-7)
A pre-bronchodilator Forced Expiratory Volume in the 1st Second ( FEV1) ≥60% and <85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits
Subjects with a positive response to a reversibility test at screening, defined as change in FEV1 (ΔFEV1) ≥12% and ≥200 mL over baseline within 30 minutes after inhaling 4 puffs of albuterol hydrofluoroalkane(HFA) 90 µg/actuation.

Key exclusion criteria (21 listed)

Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS they are willing to use a highly effective birth control methods
Subjects who suffer from Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Strategy for Prevention, Diagnosis and Management of COPD (GOLD) Report, 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as described in the GINA Report, 2016.
Inability to carry out pulmonary function testing, to comply with study procedures or with study drug intake.
Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of >10 pack-years or having stopped smoking one year or less prior to screening visit.
History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.

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
CHF 1531 pMDIDose Response: Test one of five different doses of CHF 1531	Drug	Treatment A, Treatment B, Treatment C, Treatment D
Formoterol Inhalation SolutionAlso: PERFOROMIST® 20 μg/ 2 mL vial, 1 vial BIDActive Control	Drug	Treatment F
Placebo pMDIMatched Placebo	Drug	Treatment E

Primary outcome

FEV1 Area Under the Curve Between 0 and 12 h [AUC(0-12h)], Normalized by Time -- Change From Baseline to Post Dose Day 14
Time frame: Baseline, Day 14 post-dose
Spirometry used to measure FEV1, was performed according to internationally accepted standards. Results show the change from baseline in FEV1 AUC(0-12h), normalized by time on Day 14; it was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended). Definitions: AUC=Area under the curve; AUC(0-12h)=AUC between 0 and 12 h; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period; FEV1=Forced expiratory volume in the 1st second;
Sensitivity Analysis 1: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14
Time frame: Baseline, Day 14 post-dose
The primary analysis was repeated, considering patients "as randomized" and including only the first instance of each treatment. Patients receiving the same treatment in more than one period were included in the analysis with only data from the first instance of each treatment.
Sensitivity Analysis 2: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14
Time frame: Baseline, Day 14 post-dose
The primary analysis was repeated, considering only patients and treatment periods for which treatment was assigned on or after the randomization error occurred. The number of patients shown represents those with at least one post-baseline assessment available.
Sensitivity Analysis 3: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14
Time frame: Baseline, Day 14 post-dose
Patients receiving the same treatment during two treatment periods are considered twice in the ANCOVA model (once for each period attended). Patients considered in this analysis are those with at least one available post-baseline assessment.

20 secondary outcomes

FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 1
Time frame: Baseline, Day 1 post-dose
FEV1 AUC(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
FEV1 Peak(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
FVC AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
FVC AUC(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
FVC Peak(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
Pre-dose Morning FEV1 (L) -- Change From Baseline to Post Dose Day 14
Time frame: Baseline, Day 14 post-dose
Pre-dose Morning FVC -- Change From Baseline to Post Dose Day 14
Time frame: Baseline, Day 14 post-dose
Time to Onset of Action -- Change From Baseline in Post-dose FEV1 ≥12% and ≥200 mL to Post Dose Day 1
Time frame: Baseline, Day 1 post-dose
Patients Achieving Onset of Action -- Change From Baseline in Post-dose FEV1 ≥12% and ≥200 mL to Post Dose Day 1
Time frame: Baseline, Day 1 post-dose
Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) -- Change From Baseline for Post-dose on Day 1 and on Day 14
Time frame: Baseline, Day 1 and Day 14 post-dose
12-lead ECG Parameter -- Heart Rate (HR) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
Heart Rate (HR) AUC(0-4h), Normalized by Time -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
Heart Rate (HR) Peak(0-4h), Normalized by Time -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
Heart Rate (HR) AUC(0-4h) and Peak(0-4h), Normalized by Time -- Change From Pre-dose to Post Dose Day 14
Time frame: Baseline, Day 14 post-dose
12-lead Electrocardiogram (ECG) Parameter (QTcF Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
12-lead Electrocardiogram (ECG) Parameter (PR Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
12-lead Electrocardiogram (ECG) Parameter (QRS Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
Serum Potassium -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose
Serum Glucose -- Change From Baseline to Post-dose Day 1 and Day 14
Time frame: Baseline, Day 1, Day 14 post-dose

Results and safety

Results posted to the registry on 16 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study Group	67	58

Primary outcome: FEV1 Area Under the Curve Between 0 and 12 h [AUC(0-12h)], Normalized by Time -- Change From Baseline to Post Dose Day 14

Time frame: Baseline, Day 14 post-dose. Least squares mean (95% Confidence Interval). Unit: Litres

Measure	Treatment A n = 38	Treatment B n = 35	Treatment C n = 34	Treatment D n = 40	Treatment E n = 35	Treatment F n = 41
Value	0.174 (0.141 to 0.208)	0.221 (0.186 to 0.257)	0.197 (0.161 to 0.232)	0.231 (0.199 to 0.263)	0.064 (0.030 to 0.098)	0.208 (0.175 to 0.240)

Treatment A vs Treatment E: Mean Difference (Final Values): 0.111 (95% CI 0.050 to 0.171), p <0.001, ANCOVA
Treatment B vs Treatment E: Mean Difference (Final Values): 0.158 (95% CI 0.095 to 0.220), p <0.001, ANCOVA
Treatment C vs Treatment E: Mean Difference (Final Values): 0.133 (95% CI 0.072 to 0.194), p <0.001, ANCOVA

Population analysed: Intention-to-treat (ITT): All randomized patients who received at least one dose of the study treatment within the given treatment period and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after the baseline and within the given treatment period.

Primary outcome: Sensitivity Analysis 1: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14

Time frame: Baseline, Day 14 post-dose. Least squares mean (95% Confidence Interval). Unit: Litres

Measure	Treatment A n = 38	Treatment B n = 35	Treatment C n = 34	Treatment D n = 40	Treatment E n = 35	Treatment F n = 41
Value	0.169 (0.134 to 0.205)	0.224 (0.187 to 0.260)	0.196 (0.158 to 0.233)	0.232 (0.198 to 0.265)	0.058 (0.021 to 0.094)	0.206 (0.173 to 0.239)

Treatment A vs Treatment E: Mean Difference (Final Values): 0.112 (95% CI 0.049 to 0.175), p <0.001, ANCOVA
Treatment B vs Treatment E: Mean Difference (Final Values): 0.166 (95% CI 0.101 to 0.230), p <0.001, ANCOVA
Treatment C vs Treatment E: Mean Difference (Final Values): 0.138 (95% CI 0.074 to 0.203), p <0.001, ANCOVA

Primary outcome: Sensitivity Analysis 2: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14

Time frame: Baseline, Day 14 post-dose. Least squares mean (95% Confidence Interval). Unit: Litres

Measure	Treatment A n = 31	Treatment B n = 27	Treatment C n = 28	Treatment D n = 34	Treatment E n = 32	Treatment F n = 30
Value	0.129 (0.089 to 0.170)	0.180 (0.136 to 0.223)	0.159 (0.116 to 0.201)	0.179 (0.141 to 0.217)	-0.006 (-0.047 to 0.034)	0.170 (0.129 to 0.211)

Treatment A vs Treatment E: Mean Difference (Final Values): 0.136 (95% CI 0.065 to 0.207), p <0.001, ANCOVA
Treatment B vs Treatment E: Mean Difference (Final Values): 0.186 (95% CI 0.113 to 0.258), p <0.001, ANCOVA
Treatment C vs Treatment E: Mean Difference (Final Values): 0.165 (95% CI 0.092 to 0.238), p <0.001, ANCOVA

Primary outcome: Sensitivity Analysis 3: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14

Time frame: Baseline, Day 14 post-dose. Least squares mean (95% Confidence Interval). Unit: Litres

Measure	Treatment A n = 38	Treatment B n = 35	Treatment C n = 34	Treatment D n = 40	Treatment E n = 35	Treatment F n = 41
Value	0.144 (0.103 to 0.186)	0.194 (0.151 to 0.237)	0.170 (0.128 to 0.213)	0.198 (0.157 to 0.238)	0.037 (-0.004 to 0.079)	0.184 (0.143 to 0.225)

Treatment A vs Treatment E: Mean Difference (Final Values): 0.107 (95% CI 0.048 to 0.166), p <0.001, ANCOVA
Treatment B vs Treatment E: Mean Difference (Final Values): 0.157 (95% CI 0.096 to 0.217), p <0.001, ANCOVA
Treatment C vs Treatment E: Mean Difference (Final Values): 0.133 (95% CI 0.073 to 0.193), p <0.001, ANCOVA

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first intake of study medication (Visit 2, Week 0) until study completion (Visit 10, Week 15) or study discontinuation.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 43 (0%)	2 of 43 (4.7%)	0 of 43
Treatment B	0 of 36 (0%)	1 of 36 (2.8%)	0 of 36
Treatment C	0 of 40 (0%)	2 of 40 (5%)	0 of 40
Treatment D	0 of 44 (0%)	2 of 44 (4.5%)	0 of 44
Treatment E	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Treatment F	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23245604Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.
Background: PubMed 24107140Tilert T, Dillon C, Paulose-Ram R, Hnizdo E, Doney B. Estimating the U.S. prevalence of chronic obstructive pulmonary disease using pre- and post-bronchodilator spirometry: the National Health and Nutrition Examination Survey (NHANES) 2007-2010. Respir Res. 2013 Oct 9;14(1):103. doi: 10.1186/1465-9921-14-103.
Background: PubMed 12010839Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest. 2002 May;121(5 Suppl):121S-126S. doi: 10.1378/chest.121.5_suppl.121s.
Background: PubMed 23457163Tonnesen P. Smoking cessation and COPD. Eur Respir Rev. 2013 Mar 1;22(127):37-43. doi: 10.1183/09059180.00007212.
Background: PubMed 27545342van Eerd EA, van der Meer RM, van Schayck OC, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Aug 20;2016(8):CD010744. doi: 10.1002/14651858.CD010744.pub2.
Background: PubMed 24127118Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;2013(10):CD010177. doi: 10.1002/14651858.CD010177.pub2.
Background: PubMed 25692310McGarvey L, Niewoehner D, Magder S, Sachs P, Tetzlaff K, Hamilton A, Korducki L, Bothner U, Vogelmeier C, Koch A, Ferguson GT. One-Year Safety of Olodaterol Once Daily via Respimat(R) in Patients with GOLD 2-4 Chronic Obstructive Pulmonary Disease: Results of a Pre-Specified Pooled Analysis. COPD. 2015;12(5):484-93. doi: 10.3109/15412555.2014.991864. Epub 2015 Feb 18.
Background: PubMed 20522841Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.
Background: PubMed 22217233Keating GM. Tiotropium bromide inhalation powder: a review of its use in the management of chronic obstructive pulmonary disease. Drugs. 2012 Jan 22;72(2):273-300. doi: 10.2165/11208620-000000000-00000.
Background: PubMed 15764761Casaburi R, Kukafka D, Cooper CB, Witek TJ Jr, Kesten S. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest. 2005 Mar;127(3):809-17. doi: 10.1378/chest.127.3.809.
Background: PubMed 18488436Kesten S, Casaburi R, Kukafka D, Cooper CB. Improvement in self-reported exercise participation with the combination of tiotropium and rehabilitative exercise training in COPD patients. Int J Chron Obstruct Pulmon Dis. 2008;3(1):127-36. doi: 10.2147/copd.s2389.
Background: PubMed 22786525Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009285. doi: 10.1002/14651858.CD009285.pub2.
Global Initiative for Chronic Obstructive Lung Disease, Inc. Global strategy for the diagnosis, management, and prevention of Chronic Obstructive Pulmonary Disease: 2017Link provided by the sponsor.
Global Initiative for Asthma. Global strategy for asthma management and prevention (2016 update). 2016.Link provided by the sponsor.
RT Magazine: Asthma-COPD Therapy Foradil Aerolizer to be DiscontinuedLink provided by the sponsor.
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.

Richard Sterling principal investigator

Sterling ENT, PA

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHF 1531 pMDI and Formoterol Inhalation Solution in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 10 sites 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 7 inclusion and 21 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

FEV1 Area Under the Curve Between 0 and 12 h [AUC(0-12h)], Normalized by Time -- Change From Baseline to Post Dose Day 14 (time frame: Baseline, Day 14 post-dose). The study lists 4 primary outcomes in all. 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 NCT03086460, which also lists 67 linked publications.

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 16 Aug 2021.