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- Check4 days agoChange DetectedThe study has expanded to include 52 locations, and the revision has been updated from v2.9.7 to v2.10.0.SummaryDifference0.4%
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- Check32 days agoChange DetectedThe recent change in the webpage value from 'Show more Revision: v2.9.0' to 'MedlinePlus related topics: Asthma FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Foster 100/6mg NEXThaler Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler (NEXThaler) Drug : Foster 100/6mg NEXThaler Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler Active Comparator : Foster 100/6mg pMDI Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with Hydrofluoroalkane ( HFA) -134a propellant. Drug : Foster 100/6mg pMDI Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA_134a propellant Primary Outcome Measures Outcome Measure Measure Description Time Frame Demonstration of non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function Change from Baseline to the entire treatment period in average pre-dose morning Peek Expiratory flow (PEF) Baseline to week 12 Secondary Outcome Measures Outcome Measure Measure Description Time Frame Evaluation of the effect of the test treatment in terms of additional lung function parameters and clinical outcome measures, and assessment of the safety and tolerability Changes in average pre-dose morning Peek Expiratory flow (PEF) Baseline to week 12 Evaluation of the effect of the test treatment in terms of additional lung function parameters and clinical outcome measures, and assessment of the safety and tolerability Changes in average pre-dose evening PEF Daily PEF variability Average use of rescue medication (number of puffs/day) Percentage of rescue-use free days Average total morning asthma symptom scores Average total evening asthma symptom scores Percentage of asthma symptoms-free days Percentage of asthma control days Baseline to week 12 Evaluation of the effect of the test treatment in terms of additional lung function parameters and clinical outcome measures, and assessment of the safety and tolerability Changes from Baseline in pre-dose morning Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) at each clinic visit. Baseline to Week 12 Evaluation of the effect of the test treatment in terms of additional lung function parameters and clinical outcome measures, and assessment of the safety and tolerability Change from Baseline to end of treatment in the Asthma Control Questionnaire (ACQ) Baseline to week 12 Keywords Provided by Chiesi Farmaceutici S.p.A. Peek Expiratory Flow (PEF) Lung function tests Additional Relevant MeSH Terms Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Asthma Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Helpful Links Provided by Chiesi Farmaceutici S.p.A. Lay Summary of clinical trial results is available both in English and Chinese on the Chiesi Group web-site, along with a copy of the CSR synopsis. Revision: v2.9.1'SummaryDifference28%
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