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

Asthma Clinical Trial

— BEAM  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084718
• Other study ID #: CCD-05993AA3-01
• Status: Completed
• Phase: Phase 2
• Start date: July 28, 2017
• Est. completion date: December 5, 2018

Study information

• Verified date: December 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the dose-response of different doses of CHF 781 Pressurized Metered Dose Inhaler (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: December 5, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 Global Initiative for Asthma (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 Forced Expiratory Volume in the 1st Second (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 ?FEV1=12% and =200 mL 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 long-acting bronchodilator (LABD) for 3 months (stable dose in the last 4 weeks) before screening visit (V).

• 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 visit (V1).

• A Body Mass Index (BMI): 18.5 = BMI <35 kg/m^2.

Exclusion Criteria:

• Pregnant (as evident by a positive urine human chorionic gonadotropin (hCG) or serum ß-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 chronic obstructive pulmonary disease (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) >450 ms for males or QTcF >470 ms 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-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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF 718 pMDI
Dose Response: Test one of three different doses of CHF 718 pMDI
• Placebo pMDI
Placebo Control
• Beclomethasone Dipropionate (BDP)
Active Control

Locations

Country	Name	City	State
United States	Chiesi Investigational Site	Albuquerque	New Mexico
United States	Chiesi Investigational Site	Albuquerque	New Mexico
United States	Chiesi Investigational Site	Allen	Texas
United States	Chiesi Investigational Site	Anaheim	California
United States	Chiesi Investigational Site	Anderson	South Carolina
United States	Chiesi Investigational Site	Aventura	Florida
United States	Chiesi Investigational Site	Baltimore	Maryland
United States	Chiesi Investigational Site	Beaumont	Texas
United States	Chiesi Investigational Site	Bethesda	Maryland
United States	Chiesi Investigational Site	Birmingham	Alabama
United States	Chiesi Investigational Site	Boulder	Colorado
United States	Chiesi Investigational Site	Bronx	New York
United States	Chiesi Investigational Site	Brooklyn	New York
United States	Chiesi Investigational Site	Charlotte	North Carolina
United States	Chiesi Investigational Site	Charlotte	North Carolina
United States	Chiesi Investigational Site	Chattanooga	Tennessee
United States	Chiesi Investigational Site	Chattanooga	Tennessee
United States	Chiesi Investigational Site	Chicago	Illinois
United States	Chiesi Investigational Site	Chicago	Illinois
United States	Chiesi Investigational Site	Cincinnati	Ohio
United States	Chiesi Investigational Site	Cincinnati	Ohio
United States	Chiesi Investigational Site	Clearwater	Florida
United States	Chiesi Investigational Site	Colorado Springs	Colorado
United States	Chiesi Investigational Site	Columbia	Missouri
United States	Chiesi Investigational Site	Crowley	Louisiana
United States	Chiesi Investigational Site	Cypress	Texas
United States	Chiesi Investigational Site	Dacula	Georgia
United States	Chiesi Investigational Site	Dallas	Texas
United States	Chiesi Investigational Site	Dallas	Texas
United States	Chiesi Investigational Site	Dayton	Ohio
United States	Chiesi Investigational Site	Dayton	Ohio
United States	Chiesi Investigational Site	Daytona Beach	Florida
United States	Chiesi Investigational Site	Denver	Colorado
United States	Chiesi Investigational Site	Detroit	Michigan
United States	Chiesi Investigational Site	Doral	Florida
United States	Chiesi Investigational Site	Duluth	Georgia
United States	Chiesi Investigational Site	East Providence	Rhode Island
United States	Chiesi Investigational Site	East Providence	Rhode Island
United States	Chiesi Investigational Site	Edmond	Oklahoma
United States	Chiesi Investigational Site	El Paso	Texas
United States	Chiesi Investigational Site	Encinitas	California
United States	Chiesi Investigational Site	Escondido	California
United States	Chiesi Investigational Site	Everett	Washington
United States	Chiesi Investigational Site	Fall River	Massachusetts
United States	Chiesi Investigational Site	Fall River	Massachusetts
United States	Chiesi Investigational Site	Festus	Missouri
United States	Chiesi Investigational Site	Fullerton	California
United States	Chiesi Investigational Site	Gaffney	South Carolina
United States	Chiesi Investigational Site	Gainesville	Florida
United States	Chiesi Investigational Site	Gainesville	Georgia
United States	Chiesi Investigational Site	Gastonia	North Carolina
United States	Chiesi Investigational Site	Greenfield	Wisconsin
United States	Chiesi Investigational Site	Greenville	South Carolina
United States	Chiesi Investigational Site	Greenwood	Colorado
United States	Chiesi Investigational Site	Grove City	Ohio
United States	Chiesi Investigational Site	Hendersonville	North Carolina
United States	Chiesi Investigational Site	Hialeah	Florida
United States	Chiesi Investigational Site	Hickory	North Carolina
United States	Chiesi Investigational Site	Huntington Beach	California
United States	Chiesi Investigational Site	Kissimmee	Florida
United States	Chiesi Investigational Site	Knoxville	Tennessee
United States	Chiesi Investigational Site	Las Vegas	Nevada
United States	Chiesi Investigational Site	Las Vegas	Nevada
United States	Chiesi Investigational Site	Lauderdale Lakes	Florida
United States	Chiesi Investigational Site	Little Rock	Arkansas
United States	Chiesi Investigational Site	Long Beach	California
United States	Chiesi Investigational Site	Los Angeles	California
United States	Chiesi Investigational Site	Los Angeles	California
United States	Chiesi Investigational Site	Los Angeles	California
United States	Chiesi Investigational Site	Loxahatchee Groves	Florida
United States	Chiesi Investigational Site	Maitland	Florida
United States	Chiesi Investigational Site	Marietta	Georgia
United States	Chiesi Investigational Site	McKinney	Texas
United States	Chiesi Investigational Site	Medford	Oregon
United States	Chiesi Investigational Site	Miami	Florida
United States	Chiesi Investigational Site	Miami	Florida
United States	Chiesi Investigational Site	Miami	Florida
United States	Chiesi Investigational Site	Miami	Florida
United States	Chiesi Investigational Site	Miami	Florida
United States	Chiesi Investigational Site	Minneapolis	Minnesota
United States	Chiesi Investigational Site	Missoula	Montana
United States	Chiesi Investigational Site	Monroe	North Carolina
United States	Chiesi Investigational Site	Montgomery	Alabama
United States	Chiesi Investigational Site	Mooresville	North Carolina
United States	Chiesi Investigational Site	Munroe Falls	Ohio
United States	Chiesi Investigational Site	New Orleans	Louisiana
United States	Chiesi Investigational Site	New York	New York
United States	Chiesi Investigational Site	New York	New York
United States	Chiesi Investigational Site	Newport Beach	California
United States	Chiesi Investigational Site	Norfolk	Virginia
United States	Chiesi Investigational Site	North Dartmouth	Massachusetts
United States	Chiesi Investigational Site	North Hollywood	California
United States	Chiesi Investigational Site	Omaha	Nebraska
United States	Chiesi Investigational Site	Orlando	Florida
United States	Chiesi Investigational Site	Palmetto Bay	Florida
United States	Chiesi Investigational Site	Pearland	Texas
United States	Chiesi Investigational Site	Phoenix	Arizona
United States	Chiesi Investigational Site	Plano	Texas
United States	Chiesi Investigational Site	Plantation	Florida
United States	Chiesi Investigational Site	Pompano Beach	Florida
United States	Chiesi Investigational Site	Portland	Oregon
United States	Chiesi Investigational Site	Rock Hill	South Carolina
United States	Chiesi Investigational Site	Rolla	Missouri
United States	Chiesi Investigational Site	Rolling Hills Estates	California
United States	Chiesi Investigational Site	Sacramento	California
United States	Chiesi Investigational Site	Saint Cloud	Florida
United States	Chiesi Investigational Site	Saint George	Utah
United States	Chiesi Investigational Site	Saint Louis	Missouri
United States	Chiesi Investigational Site	Saint Louis	Missouri
United States	Chiesi Investigational Site	San Antonio	Texas
United States	Chiesi Investigational Site	San Diego	California
United States	Chiesi Investigational Site	San Diego	California
United States	Chiesi Investigational Site	San Jose	California
United States	Chiesi Investigational Site	Sarasota	Florida
United States	Chiesi Investigational Site	Savannah	Georgia
United States	Chiesi Investigational Site	Sherman	Texas
United States	Chiesi Investigational Site	Skillman	New Jersey
United States	Chiesi Investigational Site	Smyrna	Tennessee
United States	Chiesi Investigational Site	South Burlington	Vermont
United States	Chiesi Investigational Site	South Dartmouth	Massachusetts
United States	Chiesi Investigational Site	Spartanburg	South Carolina
United States	Chiesi Investigational Site	Spartanburg	South Carolina
United States	Chiesi Investigational Site	Spring Hill	Tennessee
United States	Chiesi Investigational Site	Surprise	Arizona
United States	Chiesi Investigational Site	Tempe	Arizona
United States	Chiesi Investigational Site	Toledo	Ohio
United States	Chiesi Investigational Site	Tustin	California
United States	Chiesi Investigational Site	Union	South Carolina
United States	Chiesi Investigational Site	Warrensburg	Missouri
United States	Chiesi Investigational Site	Warwick	Rhode Island
United States	Chiesi Investigational Site	Westminster	California
United States	Chiesi Investigational Site	Wheat Ridge	Colorado
United States	Chiesi Investigational Site	Winston-Salem	North Carolina
United States	Chiesi Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United States, 

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* Note: There are 71 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dose Morning FEV1 at Week 8 - Change From Baseline	Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8.; Spirometry, used to measure FEV1, was performed according to internationally accepted standards.; Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;	Baseline, Week 8
Secondary	Pre-dose Morning FEV1 at Week 4 - Change From Baseline	Change from baseline in pre-dose morning FEV1 at Week 4.; Spirometry, used to measure FEV1, was performed according to internationally accepted standards.; Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;	Baseline, Week 4
Secondary	Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline	Change from baseline in pre-dose morning FVC at Week 4 and 8.; Spirometry, used to measure FVC, was performed according to internationally accepted standards.; Definitions: Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity;	Baseline, Week 4, Week 8
Secondary	Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline	The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = "totally controlled" and 6 = "severely uncontrolled". The ACQ score was calculated as the average of all 7 items.; Definitions: ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second;	Baseline, Week 4, Week 8
Secondary	Average Use of Rescue Medication - Change From Baseline	Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.; Definitions: Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
Secondary	Percentage (%) of Rescue Medication-free Days - Change From Baseline	Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline.; Definitions: Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period.; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
Secondary	Overall Daily Asthma Symptoms Scores - Change From Baseline	Overall daily asthma symptoms scores - Change From Baseline (am and pm).; Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe.; Baseline=Averages values during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
Secondary	Percentage (%) of Asthma Symptoms-free Days - Change From Baseline	Change from baseline in Percentage (%) of asthma symptoms-free days.; Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score).; Subjects recorded asthma symptom score as described in the Outcome measure #7.; Definitions: Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
Secondary	Percentage (%) of Asthma Control Days - Change From Baseline	Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.; This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use.; Definitions: Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
Secondary	Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline	Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements.; Definitions: Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening	Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
Secondary	Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline	Vital signs (systolic and diastolic blood pressure) at baseline, week 4, and week 8.; Change from baseline.; Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; DBP=Diastolic blood pressure; SBP=Systolic blood pressure;	Baseline, Week 4, Week 8
Secondary	12-lead ECG Parameters - Heart Rate - Change From Baseline	12-lead electrocardiogram (12-lead ECG) parameter - heart rate (HR) was measured at baseline (Day 1) and Week 8.; Change from baseline.; Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; bpm=Beats per minute;	Baseline, Week 8
Secondary	12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline.	12-lead electrocardiogram (12-lead ECG) parameters - PR, QRS, QTcF intervals - were measured at baseline (Day 1) and Week 8.; Changes from baseline.; Definitions: Baseline=Baseline values were defined at visit 2 (Week 0); QTcF=Fridericia-corrected QT interval; msec=Millisecond;	Baseline, Week 8
Secondary	12-lead ECG Parameters - Prolonged QTcF - Change From Baseline	Number of participants with prolonged QTcF. Change from baseline.; Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; QTcF=Fridericia-corrected QT interval;	Baseline, Week 8
Secondary	24-hr Urine Free Cortisol - Change From Baseline	24-hr Urinary Free Cortisol - Change From Baseline.; For the evaluation of the 24-hr Urine-Free cortisol excretion, 24-hour urine samples were collected. Urine-free cortisol was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).; Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;	Baseline, Week 8
Secondary	24-hr Creatinine - Change From Baseline.	24-hr Creatinine - Change From Baseline.; For the evaluation of the 24-hr creatinine excretion, 24-hour urine sample were collected. Creatinine was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).; Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;	Baseline, Week 8

External Links

•   Centers for Disease Control and Prevention - Most Recent Asthma Data
•   Chiesi Farmaceutici S.p.A - Press Release: Chiesi Farmaceutifici is the first company to submit a marketing authorisation application to the European Medicine Agency for a triple combination for the treatment of COPD
•   Chiesi Farmaceutici S.p.A. - Respiratory
•   COPD Foundation - What is COPD
•   From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
•   Global Initiative For Asthma - GINA Report 2016
•   Quest Diagnostics- Cortisol, Free and Cortisone, 24 Hour Urine with Creatinine
•   WebMD LLC - Serum Cortisol
•   Wikipedia entry - Beclomethasone dipropionate