A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
NCT ID: NCT05292586
Last Updated: 2025-09-04
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1377 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-08-31
Study Completion Date
2024-06-24
Brief Summary
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Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.
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Detailed Description
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This was a phase III, multicenter, randomized, double-blind active controlled 2-arm parallel group to compare superiority of CHF 1535 pressurised metered dose inhaler (pMDI) compared with CHF 718 pMDI, in subjects with asthma on medium or high dose inhaled corticosteroids, with regard to change from baseline in forced expiratory volume in the first second (FEV1) Area under the Curve Calculated Between Time 0 and 12 Hours (AUC0-12h) at Week 12.
After screening, eligible subjects entered a 2-week run-in period using CHF 718 (BDP) pMDI 100µg, followed by a 12-week double-blind, treatment period. Screened subjects who were on a medium dose inhaled corticosteroid (ICS) or medium dose ICS-long-acting β2-adrenergic receptor agonists (LABA) prior to the study, received CHF 718 pMDI 100µg 2 inhalations twice daily (BID) i.e. total daily dose (TDD) 400µg) during the 2-week run in period. Screened subjects who were on a high dose ICS prior to the study received CHF 718 pMDI 100µg 4 inhalations BID (TDD 800µg) during the 2-week run in period.
Following the run-in period, eligible subjects were randomized to one of two study drug arms (using a 1:1 allocation ratio) for 12 weeks. A total of 6 clinic visits (V), (V0-V5) and a follow-up call (V6) were performed during the study.
During the study, daily symptoms, rescue medication use, and compliance with the study drug were recorded via a subject-specific electronic diary (eDiary). Concomitant medications and adverse events (AEs) were assessed and recorded throughout the study. Vital signs measurements, physical exam, 12-lead electrocardiogram (ECG), peak expiratory flow (PEF), and spirometry measurements, including serial spirometry were performed and recorded. Symptoms were assessed using disease specific questionnaires. Routine hematology, blood chemistry, and urine pregnancy testing were performed before enrolment and at the end of study.
CHF 1535 pMDI = 200/6 μg pressurised metered dose inhaler (fixed combination of extrafine beclomethasone dipropionate \[BDP\] plus formoterol fumarate \[FF\]).
CHF 718 pMDI = 100 μg pressurised metered dose inhaler (extrafine beclomethasone dipropionate \[BDP\]).
After screening, eligible subjects entered a 2-week run-in period using CHF 718 (BDP) pMDI 100µg, followed by a 12-week double-blind, treatment period. Screened subjects who were on a medium dose inhaled corticosteroid (ICS) or medium dose ICS-long-acting β2-adrenergic receptor agonists (LABA) prior to the study, received CHF 718 pMDI 100µg 2 inhalations twice daily (BID) i.e. total daily dose (TDD) 400µg) during the 2-week run in period. Screened subjects who were on a high dose ICS prior to the study received CHF 718 pMDI 100µg 4 inhalations BID (TDD 800µg) during the 2-week run in period.
Following the run-in period, eligible subjects were randomized to one of two study drug arms (using a 1:1 allocation ratio) for 12 weeks. A total of 6 clinic visits (V), (V0-V5) and a follow-up call (V6) were performed during the study.
During the study, daily symptoms, rescue medication use, and compliance with the study drug were recorded via a subject-specific electronic diary (eDiary). Concomitant medications and adverse events (AEs) were assessed and recorded throughout the study. Vital signs measurements, physical exam, 12-lead electrocardiogram (ECG), peak expiratory flow (PEF), and spirometry measurements, including serial spirometry were performed and recorded. Symptoms were assessed using disease specific questionnaires. Routine hematology, blood chemistry, and urine pregnancy testing were performed before enrolment and at the end of study.
CHF 1535 pMDI = 200/6 μg pressurised metered dose inhaler (fixed combination of extrafine beclomethasone dipropionate \[BDP\] plus formoterol fumarate \[FF\]).
CHF 718 pMDI = 100 μg pressurised metered dose inhaler (extrafine beclomethasone dipropionate \[BDP\]).
Conditions
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Asthma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
The blinded roles were participant, investigator, care provider, monitor, data analyst, and assessor.
Study Groups
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CHF 1535 pMDI
CHF 1535 pMDI 800/24µg TDD
Group Type
EXPERIMENTAL
Beclomethasone Dipropionate/Formoterol Fumarate
Intervention Type
DRUG
Available in pressurized inhalation solution BDP/FF 200/6 µg
CHF 718 pMDI
CHF 718 pMDI 800µg TDD
Group Type
ACTIVE_COMPARATOR
Beclomethasone Dipropionate
Intervention Type
DRUG
Available in pressurized inhalation solution BDP 100 µg
Interventions
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Beclomethasone Dipropionate/Formoterol Fumarate
Available in pressurized inhalation solution BDP/FF 200/6 µg
Intervention Type
DRUG
Beclomethasone Dipropionate
Available in pressurized inhalation solution BDP 100 µg
Intervention Type
DRUG
Other Intervention Names
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BDP/FF
BDP
Eligibility Criteria
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Inclusion Criteria
1. Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
2. Sex and age: Male or female aged ≥18 and ≤75 years.
3. Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
4. Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
5. Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.
6. Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 \> 12% and \> 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol hydrofluoroalkane (HFA) pMDI 90µg/actuation.
Note for IC#5 and IC#6: In case the reversibility and/or quality threshold is not met at screening, the test can be performed once before randomization.
7. Female subjects:
a. Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).
8. Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.
2. Sex and age: Male or female aged ≥18 and ≤75 years.
3. Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
4. Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
5. Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.
6. Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 \> 12% and \> 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol hydrofluoroalkane (HFA) pMDI 90µg/actuation.
Note for IC#5 and IC#6: In case the reversibility and/or quality threshold is not met at screening, the test can be performed once before randomization.
7. Female subjects:
a. Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).
8. Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.
Exclusion Criteria
1. Pregnancy or lactation: where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test (serum and urine pregnancy test to be performed at screening visit and urine pregnancy test to be performed prior to randomization).
2. Poor compliance with run-in medication or eDiary completion \<50% before randomization.
3. History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk.
4. Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
5. Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening.
6. Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
7. Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
8. Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), (as defined by the current Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
9. Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit.
10. E-cigarette status: Current e-cigarettes users at the time of the screening visit.
11. Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
12. Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
13. Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate \<100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment.
14. ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF \>450ms for males or QTcF \>470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation).
15. Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
16. Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
17. Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated.
18. Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.
19. Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study.
20. Additional treatment: Subjects treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation.
21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
22. Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-immunoglobulin E (IgE), anti-IL5 or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
23. Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion.
24. Participating in other investigational trial: 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.
25. Spacer: The need to use a spacer for correct self-administration of a pMDI.
2. Poor compliance with run-in medication or eDiary completion \<50% before randomization.
3. History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk.
4. Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
5. Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening.
6. Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
7. Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
8. Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), (as defined by the current Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
9. Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit.
10. E-cigarette status: Current e-cigarettes users at the time of the screening visit.
11. Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
12. Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
13. Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate \<100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment.
14. ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF \>450ms for males or QTcF \>470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation).
15. Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
16. Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
17. Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated.
18. Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.
19. Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study.
20. Additional treatment: Subjects treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation.
21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
22. Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-immunoglobulin E (IgE), anti-IL5 or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
23. Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion.
24. Participating in other investigational trial: 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.
25. Spacer: The need to use a spacer for correct self-administration of a pMDI.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steven F. Weinstein, M.D.
Role: PRINCIPAL_INVESTIGATOR
Allergy and Asthma Specialists Medical Group and Research Center
Locations
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Chiesi Clinical Trial Site 840858
Mobile, Alabama, United States
Site Status
Chiesi Clinical Trial Site 840895
Chandler, Arizona, United States
Site Status
Chiesi Clinical Trial Site 840856
Encinitas, California, United States
Site Status
Chiesi Clinical Trial Site 840843
Huntington Beach, California, United States
Site Status
Chiesi Clinical Trial Site 840860
Huntington Beach, California, United States
Site Status
Chiesi Clinical Trial Site 840896
Long Beach, California, United States
Site Status
Chiesi Clinical Trial Site 840883
Los Angeles, California, United States
Site Status
Chiesi Clinical Trial Site 840810
Los Angeles, California, United States
Site Status
Chiesi Clinical Trial Site 840869
Newport Beach, California, United States
Site Status
Chiesi Clinical Trial Site 840890
North Hollywood, California, United States
Site Status
Chiesi Clinical Trial Site 840808
Northridge, California, United States
Site Status
Chiesi Clinical Trial Site 840879
Pomona, California, United States
Site Status
Chiesi Clinical Trial Site 840868
Sacramento, California, United States
Site Status
Chiesi Clinical Trial Site 840849
San Diego, California, United States
Site Status
Chiesi Clinical Trial Site 840877
San Diego, California, United States
Site Status
Chiesi Clinical Trial Site 840861
San Jose, California, United States
Site Status
Chiesi Clinical Trial Site 840881
Westminster, California, United States
Site Status
Chiesi Clinical Trial Site 840873
Colorado Springs, Colorado, United States
Site Status
Chiesi Clinical Trial Site 840800
Denver, Colorado, United States
Site Status
Chiesi Clinical Trial Site 840820
Coral Gables, Florida, United States
Site Status
Chiesi Clinical Trial Site 840841
Cutler Bay, Florida, United States
Site Status
Chiesi Clinical Trial Site 840817
Greenacres City, Florida, United States
Site Status
Chiesi Clinical Trial Site 840822
Hialeah, Florida, United States
Site Status
Chiesi Clinical Trial Site 840838
Hialeah, Florida, United States
Site Status
Chiesi Clinical Trial Site 840864
Kissimmee, Florida, United States
Site Status
Chiesi Clinical Trial Site 840814
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840819
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840875
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840887
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840821
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840829
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840828
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840847
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840818
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840802
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840835
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840806
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840855
Miami, Florida, United States
Site Status
Chiesi Clinical Trial Site 840809
Miami Gardens, Florida, United States
Site Status
Chiesi Clinical Trial Site 840863
Miami Lakes, Florida, United States
Site Status
Chiesi Clinical Trial Site 840865
Miami Lakes, Florida, United States
Site Status
Chiesi Clinical Trial Site 840831
Miami Springs, Florida, United States
Site Status
Chiesi Clinical Trial Site 840839
Palmetto Bay, Florida, United States
Site Status
Chiesi Clinical Trial Site 840840
Pembroke Pines, Florida, United States
Site Status
Chiesi Clinical Trial Site 840827
Pembroke Pines, Florida, United States
Site Status
Chiesi Clinical Trial Site 840811
Port Saint Lucie, Florida, United States
Site Status
Chiesi Clinical Trial Site 840889
St. Petersburg, Florida, United States
Site Status
Chiesi Clinical Trial Site 840834
St. Petersburg, Florida, United States
Site Status
Chiesi Clinical Trial Site 840880
St. Petersburg, Florida, United States
Site Status
Chiesi Clinical Trial Site 840807
Tallahassee, Florida, United States
Site Status
Chiesi Clinical Trial Site 840871
Adairsville, Georgia, United States
Site Status
Chiesi Clinical Trial Site 840824
White Marsh, Maryland, United States
Site Status
Chiesi Clinical Trial Site 840826
North Dartmouth, Massachusetts, United States
Site Status
Chiesi Clinical Trial Site 840859
Columbia, Missouri, United States
Site Status
Chiesi Clinical Trial Site 840888
Saint Charles, Missouri, United States
Site Status
Chiesi Clinical Trial Site 840846
St Louis, Missouri, United States
Site Status
Chiesi Clinical Trial Site 840867
Bellevue, Nebraska, United States
Site Status
Chiesi Clinical Trial Site 840897
Henderson, Nevada, United States
Site Status
Chiesi Clinical Trial Site 840872
North Las Vegas, Nevada, United States
Site Status
Chiesi Clinical Trial Site 840836
Brick, New Jersey, United States
Site Status
Chiesi Clinical Trial Site 840851
Albuquerque, New Mexico, United States
Site Status
Chiesi Clinical Trial Site 840899
Monroe, North Carolina, United States
Site Status
Chiesi Clinical Trial Site 840852
Raleigh, North Carolina, United States
Site Status
Chiesi Clinical Trial Site 840866
Edmond, Oklahoma, United States
Site Status
Chiesi Clinical Trial Site 840878
Tulsa, Oklahoma, United States
Site Status
Chiesi Clinical Trial Site 840884
Grants Pass, Oregon, United States
Site Status
Chiesi Clinical Trial Site 840830
Medford, Oregon, United States
Site Status
Chiesi Clinical Trial Site 840853
Portland, Oregon, United States
Site Status
Chiesi Clinical Trial Site 840885
Warwick, Rhode Island, United States
Site Status
Chiesi Clinical Trial Site 840892
Anderson, South Carolina, United States
Site Status
Chiesi Clinical Trial Site 840844
Columbia, South Carolina, United States
Site Status
Chiesi Clinical Trial Site 840850
Greenville, South Carolina, United States
Site Status
Chiesi Clinical Trial Site 840894
Rock Hill, South Carolina, United States
Site Status
Chiesi Clinical Trial Site 840891
Spartanburg, South Carolina, United States
Site Status
Chiesi Clinical Trial Site 840812
Knoxville, Tennessee, United States
Site Status
Chiesi Clinical Trial Site 840815
Baytown, Texas, United States
Site Status
Chiesi Clinical Trial Site 840874
Boerne, Texas, United States
Site Status
Chiesi Clinical Trial Site 840845
Carrollton, Texas, United States
Site Status
Chiesi Clinical Trial Site 840876
Dallas, Texas, United States
Site Status
Chiesi Clinical Trial Site 840803
El Paso, Texas, United States
Site Status
Chiesi Clinical Trial Site 840833
Houston, Texas, United States
Site Status
Chiesi Clinical Trial Site 840862
McKinney, Texas, United States
Site Status
Chiesi Clinical Trial Site 840816
McKinney, Texas, United States
Site Status
Chiesi Clinical Trial Site 840842
San Antonio, Texas, United States
Site Status
Chiesi Clinical Trial Site 840857
San Antonio, Texas, United States
Site Status
Chiesi Clinical Trial Site 840823
San Antonio, Texas, United States
Site Status
Chiesi Clinical Trial Site 840801
Sugar Land, Texas, United States
Site Status
Chiesi Clinical Trial Site 840893
Murray, Utah, United States
Site Status
Chiesi Clinical Trial Site 840837
Riverton, Utah, United States
Site Status
Chiesi Clinical Trial Site 840882
Bellingham, Washington, United States
Site Status
Chiesi Clinical Trial Site 840870
Greenfield, Wisconsin, United States
Site Status
Countries
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United States
References
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Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular Targets for Biological Therapies of Severe Asthma. Front Immunol. 2020 Nov 30;11:603312. doi: 10.3389/fimmu.2020.603312. eCollection 2020.
Reference Type
BACKGROUND
Roger JH, Bratton DJ, Mayer B, Abellan JJ, Keene ON. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment. Pharm Stat. 2019 Jan;18(1):85-95. doi: 10.1002/pst.1910. Epub 2018 Nov 8.
Reference Type
BACKGROUND
Kardas G, Kuna P, Panek M. Biological Therapies of Severe Asthma and Their Possible Effects on Airway Remodeling. Front Immunol. 2020 Jun 18;11:1134. doi: 10.3389/fimmu.2020.01134. eCollection 2020.
Reference Type
BACKGROUND
Kippelen P, Anderson SD, Hallstrand TS. Mechanisms and Biomarkers of Exercise-Induced Bronchoconstriction. Immunol Allergy Clin North Am. 2018 May;38(2):165-182. doi: 10.1016/j.iac.2018.01.008.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLI-05993AB8-02
Identifier Type: -
Identifier Source: org_study_id
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