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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Treatment C | Experimental | Treatment C, CHF 1531 pMDI: CHF 1531 pMDI 24 μg TDD: 2 inhalations of CHF 1531 pMDI 6 μg/actuation BID. |
|
| Treatment D | Experimental | Treatment D, CHF 1531 pMDI CHF 1531 pMDI 48 μg TDD: 2 inhalations of CHF 1531 pMDI 12 μg/actuation BID. |
|
| Treatment E | Experimental | Treatment E, Matched placebo Placebo: 2 inhalations of CHF 1531 pMDI matched Placebo BID. |
|
| Treatment F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 1531 pMDI | Drug | Dose Response: Test one of five different doses of CHF 1531 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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; | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Sterling | Sterling ENT, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiesi Investigational Site | Tucson | Arizona | 85710 | United States | ||
| Chiesi Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23245604 | Background | 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. |
| Label | URL |
|---|---|
| Global Initiative for Chronic Obstructive Lung Disease, Inc. Global strategy for the diagnosis, management, and prevention of Chronic Obstructive Pulmonary Disease: 2017 | View source |
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Adult patients with confirmed diagnosis of asthma were recruited into the study according to the trial inclusion and exclusion criteria and were randomized into one of the 6 treatment groups. The total daily dose (TDD) of the trial investigational drug CHF 1531 pressurized metered dose Inhaler (pMDI), inhalation solution (IS) of the direct comparator, or matched placebo is indicated for each treatment group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Group | Each eligible patient was randomly assigned to one of the 12 treatments sequences. The study had an incomplete cross-over design. Patients were planned to take 4 out of 6 treatments, according to one of 12 possible sequences using a balanced incomplete block randomization scheme. Treatment intervals were separated by 2-week wash-out periods. For clarity, a summary of study participants who received treatment A, B, C, D, E, and F is presented below as milestones and also as periods. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Study Participants |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2017 | Jun 17, 2021 |
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| 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. |
|
| Formoterol Inhalation Solution | Drug | Active Control |
|
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| Placebo pMDI | Drug | Matched Placebo |
|
| Baseline, Day 14 post-dose |
| 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; | 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; | 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; | 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; | 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; | 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; | 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; | 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; | 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); | 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; | 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. | 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. | 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; | 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; | 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. | 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. | 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. | 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. | 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. | Baseline, Day 1, Day 14 post-dose |
| Los Angeles |
| California |
| 90048 |
| United States |
| Chiesi Investigational Site | Lutherville | Maryland | 21093 | United States |
| Chiesi Investigational Site | St Louis | Missouri | 63141 | United States |
| Chiesi Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Chiesi Investigational Site | Greenville | South Carolina | 29615 | United States |
| Chiesi Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| Chiesi Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| Chiesi Investigational Site | Knoxville | Tennessee | 37909 | United States |
| Chiesi Investigational Site | Richland | Washington | 99352 | United States |
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| 25841237 | Background | Frith PA, Thompson PJ, Ratnavadivel R, Chang CL, Bremner P, Day P, Frenzel C, Kurstjens N; Glisten Study Group. Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. Thorax. 2015 Jun;70(6):519-27. doi: 10.1136/thoraxjnl-2014-206670. Epub 2015 Apr 3. |
| 26451734 | Background | Siler TM, Kerwin E, Singletary K, Brooks J, Church A. Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies. COPD. 2016;13(1):1-10. doi: 10.3109/15412555.2015.1034256. Epub 2015 Oct 9. |
| 27598678 | Background | Singh D, Papi A, Corradi M, Pavlisova I, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016 Sep 3;388(10048):963-73. doi: 10.1016/S0140-6736(16)31354-X. Epub 2016 Sep 1. |
| 16424409 | Background | Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006 Jan;129(1):15-26. doi: 10.1378/chest.129.1.15. |
| 19797669 | Background | Wijesinghe M, Weatherall M, Perrin K, Harwood M, Beasley R. Risk of mortality associated with formoterol: a systematic review and meta-analysis. Eur Respir J. 2009 Oct;34(4):803-11. doi: 10.1183/09031936.00159708. |
| 20181964 | Background | Chowdhury BA, Dal Pan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med. 2010 Apr 1;362(13):1169-71. doi: 10.1056/NEJMp1002074. Epub 2010 Feb 24. No abstract available. |
| 19369675 | Background | Drazen JM, O'Byrne PM. Risks of long-acting beta-agonists in achieving asthma control. N Engl J Med. 2009 Apr 16;360(16):1671-2. doi: 10.1056/NEJMe0902057. No abstract available. |
| 21714647 | Background | Chowdhury BA, Seymour SM, Levenson MS. Assessing the safety of adding LABAs to inhaled corticosteroids for treating asthma. N Engl J Med. 2011 Jun 30;364(26):2473-5. doi: 10.1056/NEJMp1104375. No abstract available. |
| 26949137 | Background | Stempel DA, Raphiou IH, Kral KM, Yeakey AM, Emmett AH, Prazma CM, Buaron KS, Pascoe SJ; AUSTRI Investigators. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med. 2016 May 12;374(19):1822-30. doi: 10.1056/NEJMoa1511049. Epub 2016 Mar 6. |
| 27579634 | Background | Stempel DA, Szefler SJ, Pedersen S, Zeiger RS, Yeakey AM, Lee LA, Liu AH, Mitchell H, Kral KM, Raphiou IH, Prillaman BA, Buaron KS, Yun Kirby S, Pascoe SJ; VESTRI Investigators. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. N Engl J Med. 2016 Sep 1;375(9):840-9. doi: 10.1056/NEJMoa1606356. |
| Background | Novartis Pharma. FORADIL®AEROLIZER® US Prescribing Information. Whitehouse Station, New Jersey; 2012 Sep. |
| Background | Chiesi Farmaceutici S.p.A. A randomized, double blind, double dummy, cumulative dose, safety cross-over trial comparing 4 increasing doses of Formoterol-HFA (pMDI) versus 4 increasing doses of formoterol-DPI (Aerolizer®) and placebo (pMDI or Aerolizer ®) in asthmatic patients. RA/PR/3301/002/01. |
| Background | Chiesi Farmaceutici S.p.A. A randomized, double blind, double dummy, single dose, crossover trial comparing the efficacy and safety of a single dose administered via 1 puff of 6 μg or 2 puffs of 6 μg of formoterol-HFA (pMDI) versus a single dose of 12 μg of formoterol- DPI (Foradil®Aerolizer®) and of placebo (pMDI or Aerolizer®) in moderate to severe asthmatic patients. RA/PR/3301/009/03. |
| 11206232 | Background | Bensch G, Lapidus RJ, Levine BE, Lumry W, Yegen U, Kiselev P, Della Cioppa G. A randomized, 12-week, double-blind, placebo-controlled study comparing formoterol dry powder inhaler with albuterol metered-dose inhaler. Ann Allergy Asthma Immunol. 2001 Jan;86(1):19-27. doi: 10.1016/s1081-1206(10)62351-4. |
| 14529100 | Background | Pleskow W, LaForce CF, Yegen U, Matos D, Della Cioppa G. Formoterol delivered via the dry powder Aerolizer inhaler versus albuterol MDI and placebo in mild-to-moderate asthma: a randomized, double-blind, double-dummy trial. J Asthma. 2003;40(5):505-14. doi: 10.1081/jas-120018780. |
| 11549532 | Background | Dahl R, Greefhorst LA, Nowak D, Nonikov V, Byrne AM, Thomson MH, Till D, Della Cioppa G; Formoterol in Chronic Obstructive Pulmonary Disease I Study Group. Inhaled formoterol dry powder versus ipratropium bromide in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):778-84. doi: 10.1164/ajrccm.164.5.2007006. |
| 11948033 | Background | Rossi A, Kristufek P, Levine BE, Thomson MH, Till D, Kottakis J, Della Cioppa G; Formoterol in Chronic Obstructive Pulmonary Disease (FICOPD) II Study Group. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest. 2002 Apr;121(4):1058-69. doi: 10.1378/chest.121.4.1058. |
| Background | Mylan Specialty L.P. PERFOROMIST® US Prescribing Information. Morgantown, West Virginia; 2013 Mar. |
| 18363201 | Background | Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97. doi: 10.1016/j.rmed.2007.10.007. |
| Background | Chiesi Farmaceutici S.p.A. CHF 1535 HFA : BDP + formoterol 100/6 μg pressurized inhalation solution : Common Technical Document. Module 2.5: 8. |
| 15915008 | Background | Bousquet J, Guenole E, Duvauchelle T, Vicaut E, Lefrancois G. A randomized, double-blind, double-dummy, single-dose, crossover trial evaluating the efficacy and safety profiles of two dose levels (12 and 24 microg) of formoterol-HFA (pMDI) vs. those of a dose level (24 microg) of formoterol-DPI (Foradil/Aerolizer) and of placebo (pMDI or Aerolizer) in moderate to severe asthmatic patients. Respiration. 2005;72 Suppl 1:13-9. doi: 10.1159/000083688. |
| 8499054 | Background | Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. No abstract available. |
| 15373928 | Background | Houghton CM, Langley SJ, Singh SD, Holden J, Monici Preti AP, Acerbi D, Poli G, Woodcock A. Comparison of bronchoprotective and bronchodilator effects of a single dose of formoterol delivered by hydrofluoroalkane and chlorofluorocarbon aerosols and dry powder in a double blind, placebo-controlled, crossover study. Br J Clin Pharmacol. 2004 Oct;58(4):359-66. doi: 10.1111/j.1365-2125.2004.02172.x. |
| 16226443 | Background | Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006 Apr;100(4):616-21. doi: 10.1016/j.rmed.2005.08.012. Epub 2005 Oct 13. |
| 16264058 | Background | Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available. |
| 23217058 | Background | Arievich H, Overend T, Renard D, Gibbs M, Alagappan V, Looby M, Banerji D. A novel model-based approach for dose determination of glycopyrronium bromide in COPD. BMC Pulm Med. 2012 Dec 8;12:74. doi: 10.1186/1471-2466-12-74. |
| Background | Center for Drug Evaluation and Research Medical Review. Clinical Team Leader Memorandum: Formoterol fumarate inhalation solution 20mcg/2mL; NDA # 22-007: 2007 Mar 15. |
| 18655841 | Background | Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8. |
| 10573240 | Background | Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x. |
| 16055882 | Background | Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available. |
| 19741060 | Background | Hankinson JL, Kawut SM, Shahar E, Smith LJ, Stukovsky KH, Barr RG. Performance of American Thoracic Society-recommended spirometry reference values in a multiethnic sample of adults: the multi-ethnic study of atherosclerosis (MESA) lung study. Chest. 2010 Jan;137(1):138-45. doi: 10.1378/chest.09-0919. Epub 2009 Sep 9. |
| 2001060 | Background | Hankinson JL, Bang KM. Acceptability and reproducibility criteria of the American Thoracic Society as observed in a sample of the general population. Am Rev Respir Dis. 1991 Mar;143(3):516-21. doi: 10.1164/ajrccm/143.3.516. |
| 19535666 | Background | Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST. |
| 25676887 | Background | Virchow JC, Backer V, de Blay F, Kuna P, Ljorring C, Prieto JL, Villesen HH. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Respir Med. 2015 May;109(5):547-56. doi: 10.1016/j.rmed.2015.01.012. Epub 2015 Feb 3. |
| 3427176 | Background | Edwards D, Berry JJ. The efficiency of simulation-based multiple comparisons. Biometrics. 1987 Dec;43(4):913-28. |
| Global Initiative for Asthma. Global strategy for asthma management and prevention (2016 update). 2016. | View source |
| Centers for Disease Control and Prevention: Asthma | View source |
| RT Magazine: Asthma-COPD Therapy Foradil Aerolizer to be Discontinued | View source |
|
| Treatment A | Number of patients who received Treatment A. |
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| Treatment B | Number of patients who received Treatment B. |
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| Treatment C | Number of patients who received Treatment C. |
|
| Treatment D | Number of patients who received Treatment D. |
|
| Treatment E | Number of patients who received Treatment E. |
|
| Treatment F | Number of patients who received Treatment F. |
|
| COMPLETED | Patients who received the same treatment during two treatment intervals were considered twice in the corresponding group (once for each treatment interval). The table above presents the number of patients receiving each treatment in at least one treatment interval. |
|
| NOT COMPLETED |
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| Treatment A |
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| Treatment B |
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| Treatment C |
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| Treatment D |
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| Treatment E |
|
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| Treatment F |
|
Intention-to-treat (ITT): All randomized patients who received at least one dose of the study treatment within the given period and with at least one available evaluation of efficacy (primary or secondary efficacy variables) after the baseline and within the given period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trial Participants | All trial participants had diagnosed asthma and were randomized to 6 treatments in a cross-over study design. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Time since first diagnosis of asthma | Median | Full Range | months |
| |||||||||||||||||
| Age at first diagnosis of asthma | Mean | Standard Deviation | years |
| |||||||||||||||||
| Asthma medication category at study entry | Count of Participants | Participants |
| ||||||||||||||||||
| Smoking habits | Count of Participants | Participants |
| ||||||||||||||||||
| Duration of smoking | Only 9 trial participants had smoked (ex-smokers); thus, results on 9 participants are reported. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Number of pack-years | Only 9 trial participants had smoked (ex-smokers). | Median | Full Range | pack-years |
| ||||||||||||||||
| FEV1 at screening (pre-bronchodilator) | Measure description: Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath during the first second (i.e. FEV1) of the expiratory maneuver. | Mean | Standard Deviation | Litre |
| ||||||||||||||||
| FEV1 % of the normal predicted value (pre-bronchodilator) | Mean | Standard Deviation | percent |
| |||||||||||||||||
| FEV1 at screening (post-bronchodilator) | Mean | Standard Deviation | Litre |
| |||||||||||||||||
| FEV1 % of the normal predicted value (post-bronchodilator) | Mean | Standard Deviation | percent |
| |||||||||||||||||
| FVC at screening (pre-bronchodilator) | Measure description: Forced vital capacity (FVC) is the maximal volume of gas that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible. | Mean | Standard Deviation | Litre |
| ||||||||||||||||
| FVC at screening (post-bronchodilator) | Mean | Standard Deviation | Litre |
| |||||||||||||||||
| Reversibility FEV1 (mL) at screening | Mean | Standard Deviation | millilitre |
| |||||||||||||||||
| Reversibility FEV1 (%) at screening | Mean | Standard Deviation | percent |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 14 post-dose |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 14 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 14 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 14 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 1 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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; | 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. Due to an error in the randomization system during the trial, some patients received the same treatment in several treatment period, as summarized in section Participant Flow. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 1, Day 14 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 1, Day 14 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 1, Day 14 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 1, Day 14 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 14 post-dose |
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| Secondary | 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; | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Litres | Baseline, Day 14 post-dose |
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| Secondary | 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; | 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. | Posted | Median | 95% Confidence Interval | minutes | Baseline, Day 1 post-dose |
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| Secondary | 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); | 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. | Posted | Count of Participants | Participants | Baseline, Day 1 post-dose |
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| Secondary | 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; | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | Full Range | mmHg | Baseline, Day 1 and Day 14 post-dose |
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| Secondary | 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. | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | Full Range | bpm | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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. | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | 90% Confidence Interval | bpm | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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; | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | 90% Confidence Interval | bpm | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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; | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | 90% Confidence Interval | bpm | Baseline, Day 14 post-dose |
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| Secondary | 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. | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | Full Range | msec | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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. | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | Full Range | msec | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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. | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | Full Range | msec | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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. | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | Full Range | mmol/L | Baseline, Day 1, Day 14 post-dose |
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| Secondary | 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. | Safety population: All randomized patients who received at least one dose of study treatment within the given period. | Posted | Mean | Full Range | mmol/L | Baseline, Day 1, Day 14 post-dose |
|
From the first intake of study medication (Visit 2, Week 0) until study completion (Visit 10, Week 15) or study discontinuation.
Safety population was used for the evaluation of treatment-emergent adverse event (TEAEs).
The safety population is defined as all randomized patients who received at least one dose of study treatment within the given treatment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Treatment A CHF 1531 pMDI: 6 μg TDD | 0 | 43 | 0 | 43 | 2 | 43 |
| EG001 | Treatment B | Treatment B CHF 1531 pMDI: 12 μg TDD | 0 | 36 | 0 | 36 | 1 | 36 |
| EG002 | Treatment C | Treatment C CHF 1531 pMDI: 24 μg TDD | 0 | 40 | 0 | 40 | 2 | 40 |
| EG003 | Treatment D | Treatment D CHF 1531 pMDI: 48 μg TDD | 0 | 44 | 0 | 44 | 2 | 44 |
| EG004 | Treatment E | Treatment E Matched placebo | 0 | 45 | 0 | 45 | 0 | 45 |
| EG005 | Treatment F | Treatment F Formoterol fumarate IS Perforomist®: 40 μg TDD | 0 | 41 | 0 | 41 | 1 | 41 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 20.0 | Systematic Assessment |
|
Chiesi can publish and/or present any results of this study at scientific meetings, and to submit the clinical trial data to national and international Regulatory Authorities. Chiesi reserves the right to use such data for industrial purposes. Investigators will inform Chiesi before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation. Data from individual study sites must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Transparency | Chiesi Farmaceutici S.p.A. | + 39 0521 2791 | clinicaltrials_info@chiesi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2019 | Jun 17, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
Not provided
Not provided
| >=65 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Theophylline |
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| Inhaled corticosteroid (ICS) alone |
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| ICS/Long-acting muscarinic antagonist (LABA), (free or fixed combination) |
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| ICS/Long-acting muscarinic antagonist (LAMA), (free combination) |
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| ICS/LABA/LAMA |
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| Non-smoker |
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| Comparison groups were: Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo). Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure. | ANCOVA | <0.001 | Mean Difference (Final Values) | 0.158 | 2-Sided | 95 | 0.095 | 0.220 | Superiority |
| Comparison groups were: Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo). Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure. | ANCOVA | <0.001 | Mean Difference (Final Values) | 0.133 | 2-Sided | 95 | 0.072 | 0.194 | Superiority |
| Comparison groups were: Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo). Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure. | ANCOVA | <0.001 | Mean Difference (Final Values) | 0.167 | 2-Sided | 95 | 0.109 | 0.225 | Superiority |
| Comparison groups were: Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo). The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate. | ANCOVA | <0.001 | Mean Difference (Final Values) | 0.144 | 2-Sided | 95 | 0.098 | 0.190 | Superiority |
| Comparison groups were: Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD). The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate. | ANCOVA | 0.059 | Mean Difference (Final Values) | 0.047 | 2-Sided | 95 | -0.002 | 0.095 | Superiority |
| Comparison groups were: Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD). Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure. | ANCOVA | 0.361 | Mean Difference (Final Values) | 0.022 | 2-Sided | 95 | -0.026 | 0.070 | Superiority |
| Comparison groups were: Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD). Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure. | ANCOVA | 0.016 | Mean Difference (Final Values) | 0.057 | 2-Sided | 95 | 0.011 | 0.102 | Superiority |
| Comparison groups were: Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD). Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure. | ANCOVA | 0.340 | Mean Difference (Final Values) | -0.025 | 2-Sided | 95 | -0.075 | 0.026 | Superiority |
| Comparison groups were: Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD). Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure. | ANCOVA | 0.690 | Mean Difference (Final Values) | 0.010 | 2-Sided | 95 | -0.038 | 0.058 | Superiority |
| Comparison groups were: Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD). Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure. | ANCOVA | 0.155 | Mean Difference (Final Values) | 0.034 | 2-Sided | 95 | -0.013 | 0.082 | Superiority |
Treatment D, CHF 1531 pMDI: 48 μg TDD
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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|
Treatment D, CHF 1531 pMDI: 48 μg TDD
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
|
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|
Treatment D, CHF 1531 pMDI: 48 μg TDD
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
|
|
|
Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG003 | Treatment D | Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| Treatment D |
Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
|
|
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Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG003 | Treatment D | Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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Treatment C, CHF 1531 pMDI: 24 μg TDD
| OG003 | Treatment D | Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
|
|
Treatment C, CHF 1531 pMDI: 24 μg TDD |
| OG003 | Treatment D | Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG004 |
| Treatment E |
Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
|
|
Treatment D, CHF 1531 pMDI: 48 μg TDD |
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
|
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Treatment D, CHF 1531 pMDI: 48 μg TDD
| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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| OG004 | Treatment E | Treatment E, Matched placebo |
| OG005 | Treatment F | Treatment F, Formoterol fumarate IS Perforomist®: 40 μg TDD |
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