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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002142-13 | EudraCT Number | ||
| MK-0887A-202 | Other Identifier | Merck Protocol Number |
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The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate/Formoterol MDI BID | Experimental | MF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments) |
|
| Mometasone Furoate MDI BID | Active Comparator | MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate/Formoterol MDI 100/5 mcg | Drug | two inhalations BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms | The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant. | 26 weeks, or 7 days after the last treatment dose, whichever occurred later |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms | The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of SAO Components in MF/F Participants vs MF Participants | To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30537475 | Result | Weinstein CLJ, Ryan N, Shekar T, Gates D, Lane SJ, Agache I, Nathan RA; SPIRO Investigators. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. 2019 Apr;143(4):1395-1402. doi: 10.1016/j.jaci.2018.10.065. Epub 2018 Dec 8. | |
| 36472162 | Derived | Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. |
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11,744 participants were enrolled in the study and 11,729 participants were randomized and received at least one dose of blinded study treatment (defined as the number started). Treatments were Mometasone Furoate/Formoterol (MF/F) metered dose inhaler (MDI) twice daily (BID) and Mometasone Furoate (MF) MDI BID.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate/Formoterol (MF/F) MDI BID | MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol |
| FG001 | Mometasone Furoate (MF) MDI BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mometasone Furoate/Formoterol MDI 200/5 mcg | Drug | two inhalations BID |
|
|
| Mometasone Furoate MDI 100 mcg | Drug | two inhalations BID |
|
|
| Mometasone Furoate MDI 200 mcg | Drug | two inhalations BID |
|
|
| Albuterol 90 mcg /salbutamol 100 mcg HFA MDI | Drug | use as needed for asthma symptoms |
|
| Prednisone/prednisolone | Drug | Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator |
|
| 26 weeks, plus 7 days after the last treatment |
| 26 weeks, or 7 days after the last treatment dose, whichever occurred later |
MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol |
| COMPLETED |
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| NOT COMPLETED |
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|
These are all participants who were randomized and treated with at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate/Formoterol (MF/F) MDI BID | MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol |
| BG001 | Mometasone Furoate (MF) MDI BID | MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Treatment Covariates (MF/F or MF) and ICS Dose Level (100 or 200 mcg, per actuation) | The primary safety hypothesis will be evaluated using Cox proportional-hazard model including covariates of treatment (MF/F MDI BID vs MF MDI BID) and ICS dose level (100 mcg vs 200 mcg, per actuation). | Count of Participants | Participants |
|
| 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 | Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms | The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant. | The analyzed population for assessment of the number of first SAO was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle). | Posted | Number | Serious asthma outcomes | 26 weeks, or 7 days after the last treatment dose, whichever occurred later |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms | The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant. | The analyzed population for assessment of the number of first asthma exacerbations was all treated participants who received at least one dose of randomized treatment assignment (intention-to-treat principle). | Posted | Number | Asthma exacerbations | 26 weeks, plus 7 days after the last treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of SAO Components in MF/F Participants vs MF Participants | To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only. | The analyzed population for tabulation of the number of SAO components was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle). | Posted | Number | SAO components | 26 weeks, or 7 days after the last treatment dose, whichever occurred later |
|
26 weeks, or 7 days after the last treatment dose, whichever occurred later
All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MF/F MDI BID | 5 | 5,868 | 136 | 5,868 | 67 | 5,868 | |
| EG001 | MF MDI BID | 4 | 5,861 | 137 | 5,861 | 75 | 5,861 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Mitral valve stenosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastric dysplasia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrooesophageal sphincter insufficiency | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anicteric leptospirosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Eczema infected | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Intentional product misuse | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperosmolar state | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Benign neoplasm of spinal cord | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Carcinoid tumour of the duodenum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Medullary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Encephalitis autoimmune | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Spondylitic myelopathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Schizophreniform disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin hypertrophy | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tongue discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngeal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchospasm paradoxical | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Hypopnea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oral mucosal erythema | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Allergic edema | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
|
The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor, and to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication which report any trial results. The sponsor has the right to review and comment on publications, abstracts, slides, and manuscripts, and to review and comment on data analysis and presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
|---|---|
| D000068656 | Mometasone Furoate |
| D000068758 | Mometasone Furoate, Formoterol Fumarate Drug Combination |
| D000420 | Albuterol |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D011246 | Pregnadienetriols |
Not provided
Not provided
| Male |
|
| MF/F 400/10 mcg |
|
| MF 200 mcg |
|
| MF 400 mcg |
|
| MF MDI BID |
MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|