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

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ClinicalTrials.gov Identifier: NCT03084718
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the dose-response of different doses of CHF 781 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target patient population.

Condition or disease Intervention/treatment Phase
Asthma Drug: CHF 781 Drug: Placebos Drug: Beclomethasone Dipropionate Phase 2

Detailed Description:

This is a phase II, multicenter, randomized, double-blind, placebo and active controlled dose ranging 5-arm parallel group study to identify the optimal dose of CHF 781 pMDI with respect to lung function and other clinical efficacy and safety outcomes.

After a 2 week run-in period under rescue albuterol as needed and background inhaled corticosteroid (ICS), patients will be randomized to one of the 5 study treatment groups. After randomization, patients will be assessed after 4 and 8 weeks of study treatment at the center. A follow-up phone call will be performed a week after the last visit.

During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication will be recorded via subject diary. Treatment-Emergent Adverse Events (TEAEs) will be assessed and recorded throughout the study. At screening and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurements, and 12-lead ECG. Routine hematology, blood chemistry, and pregnancy testing will be performed before enrollment and at end of study. 24-hr urine cortisol and creatinine will be assessed before and after the first dose and just before the last dose of study treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 619 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A
CHF 718 pMDI Dose 1
 Drug: CHF 781
Dose Response: Test one of three different doses of CHF 781
Other Name: Dose Finding
Experimental: Treatment B
CHF 718 pMDI Dose 2
 Drug: CHF 781
Dose Response: Test one of three different doses of CHF 781
Other Name: Dose Finding
Experimental: Treatment C
CHF 718 pMDI Dose 3
 Drug: CHF 781
Dose Response: Test one of three different doses of CHF 781
Other Name: Dose Finding
Placebo Comparator: Treatment D
Placebo Control, Placebos
 Drug: Placebos
Placebo Control
Active Comparator: Treatment E
Beclomethasone dipropionate HFA, 80µg (pMDI)
 Drug: Beclomethasone Dipropionate
Active Control
Other Name: QVAR® 80µg


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in pre-dose morning FEV1 at Week 8 [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline in pre-dose morning FEV1 at Week 4 [ Time Frame: 4 Weeks ]
  2. Change from baseline in pre-dose morning FVC at Week 4 and 8 [ Time Frame: 4 Weeks & 8 Weeks ]
  3. Change from baseline in ACQ-7 score at Week 4 and 8 [ Time Frame: 4Weeks & 8 Weeks ]
  4. Change from baseline in % rescue medication-free days [ Time Frame: 8 Weeks ]
  5. Change from baseline in % asthma symptoms-free days [ Time Frame: 8 Weeks ]
  6. Change from baseline in % asthma control days [ Time Frame: 8 Weeks ]
  7. Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [ Time Frame: 8 Weeks ]
  8. Vital signs (systolic and diastolic blood pressure) [ Time Frame: 8 Weeks ]
  9. 12-lead ECG parameters (HR, QTcF, QRS, PR) [ Time Frame: 8 Weeks ]
  10. Standard blood chemistry and hematology [ Time Frame: 8 Weeks ]
  11. 24-hr Urinary Free Cortisol and Creatinine [ Time Frame: 8 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 GINA Report, 2016, documented for at least 1 year prior to screening.
  • Subjects with poorly controlled or uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire 7 © (ACQ-7) ≥1.5 (this criterion must be met at screening and at randomization visits).
  • Subjects with a pre-bronchodilator FEV1 ≥50% 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 (pre - post BD), within 1 year prior to or at screening defined as ΔFEV1≥12% and ≥200mL over baseline within 30 minutes after inhaling 4 puffs of albuterol HFA 90µg/actuation.
  • Use of inhaled corticosteroids (low/medium dose according to GINA Report 2016) with or without a LABD for 3 months (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 inhalers.
  • A basal morning (7-10 am) serum cortisol level between 7-28 µg/dL at screening (V1).
  • A Body Mass Index: 18.5 ≤ BMI <35 kg/m2.

Exclusion Criteria:

  • Pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control method
  • Subjects who suffer from COPD as defined by the GOLD Report 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as defined in GINA Report, 2016.
  • Inability to carry out pulmonary lung 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 corticosteroids within 3 months or hospitalization within 6 months prior to screening.
  • 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 or at randomization.
  • Subjects with any clinically significant, uncontrolled condition
  • 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 subject according to Investigator's judgement.
  • Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450ms for males or QTcF >470ms for females at screening and randomization visits.
  • Subjects with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
  • Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-IgE, anti-IL5 or other monoclonal or polycolonal 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084718


Locations
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Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: David Bernstein, MD Bernstein Clinical Research Center, LLC
More Information
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Additional Information:

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 León 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. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].
GlaxoSmithKline. Cross Discipline Team Leader Review: Application number 204275Orig1s000; 2013 Apr 1.
GlaxoSmithKline. BREO® ELLIPTA® US Prescribing Information. Research Triangle Park, North Carolina; 2015 Apr.
Teva Respiratory LLC. QVAR® US Prescribing Information. Horsham, Pennsylvania; 2014 Jul.
GlaxoSmithKline. ARNUITY® ELLIPTA® US Prescribing Information. Research Triangle Park, North Carolina; 2014 Aug.
Chiesi Farmaceutici S.p.A. A double blind double dummy, multiple dose comparison of two parallel groups comparing a daily dose of extrafine BDP HFA 400µg vs. BDP CFC 1000µg in asthmatic patients over an 8-week treatment period. 2005 Jul;DM/PR/3303/006/03.
Mallinckrodt C, Roger J, Chuang-stein C, Molenberghs G, Lane PW, O'Kelly M, et al. Missing data: turning guidance into action. Stat Biopharm Res. 2013;5(4):369-82.
Mallinckrodt CH, Kenward MG. Conceptual Considerations regarding Endpoints, Hypotheses, and Analyses for Incomplete Longitudinal Clinical Trial Data. Drug Inf J. 2009; 43(4): 449-58.

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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT03084718    
Other Study ID Numbers: CCD-05993AA3-01
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents