{
  "topic": {
    "stem": "TEZEPELUMAB_ASTHMA_REVIEW",
    "name": "Tezepelumab in severe asthma",
    "ncts": [
      "NCT03347279",
      "NCT04039113",
      "NCT03406078",
      "NCT03968978"
    ],
    "drug_patterns": [
      "tezepelumab"
    ],
    "condition_patterns": [
      "asthma"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03347279",
        "aact_title": "Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma",
        "aact_acronym": "NAVIGATOR",
        "start_date": "2017-11-23",
        "primary_completion_date": "2020-09-08",
        "aact_intvs": [
          "Experimental: Tezepelumab",
          "Placebo"
        ],
        "aact_conditions": [
          "asthma"
        ],
        "pmid": "41072729",
        "pubmed_year": 2026,
        "pubmed_doi": "10.1016/j.anai.2025.09.015",
        "aact_per_arm_counts": {
          "BG000": 528,
          "BG001": 531
        },
        "aact_primary_outcome_measure": "Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma",
        "aact_outcome_count_rows": [
          [
            "OG001",
            "18.0"
          ],
          [
            "OG000",
            "4.7"
          ],
          [
            "OG001",
            "12.2"
          ],
          [
            "OG000",
            "231.0"
          ],
          [
            "OG001",
            "319.0"
          ],
          [
            "OG000",
            "96.0"
          ],
          [
            "OG001",
            "60.0"
          ],
          [
            "OG000",
            "199.0"
          ],
          [
            "OG001",
            "132.0"
          ],
          [
            "OG000",
            "98.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": false,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04039113",
        "aact_title": "Tezepelumab COPD Exacerbation Study",
        "aact_acronym": "COURSE",
        "start_date": "2019-07-30",
        "primary_completion_date": "2023-11-10",
        "aact_intvs": [
          "Tezepelumab",
          "Placebo"
        ],
        "aact_conditions": [
          "chronic obstructive pulmonary disease (copd)"
        ],
        "pmid": "39653044",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1016/S2213-2600(24)00324-2",
        "aact_per_arm_counts": {
          "BG000": 165,
          "BG001": 168
        },
        "aact_primary_outcome_measure": "Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD.",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "94.0"
          ],
          [
            "OG001",
            "8.0"
          ],
          [
            "OG001",
            "105.0"
          ],
          [
            "OG000",
            "71.0"
          ],
          [
            "OG001",
            "63.0"
          ],
          [
            "OG000",
            "16.0"
          ],
          [
            "OG001",
            "22.0"
          ],
          [
            "OG000",
            "16.0"
          ],
          [
            "OG001",
            "22.0"
          ],
          [
            "OG000",
            "65.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03406078",
        "aact_title": "Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma",
        "aact_acronym": "SOURCE",
        "start_date": "2018-03-05",
        "primary_completion_date": "2020-09-25",
        "aact_intvs": [
          "Tezepelumab",
          "Placebo"
        ],
        "aact_conditions": [
          "asthma"
        ],
        "pmid": "36702146",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1016/S2213-2600(22)00492-1",
        "aact_per_arm_counts": {
          "BG000": 74,
          "BG001": 76
        },
        "aact_primary_outcome_measure": "Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "71.6"
          ],
          [
            "OG000",
            "26.0"
          ],
          [
            "OG001",
            "43.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG000",
            "40.0"
          ],
          [
            "OG001",
            "35.0"
          ],
          [
            "OG000",
            "5.0"
          ],
          [
            "OG001",
            "4.0"
          ],
          [
            "OG000",
            "10.0"
          ],
          [
            "OG001",
            "14.0"
          ]
        ],
        "published_effect_type": "MD",
        "published_effect_size": -13.04,
        "published_ci_lower": -17.83,
        "published_ci_upper": -8.18,
        "published_source_snippet": "difference -13.04; 95% CI -17.83 to -8.18",
        "published_extractor": "rct-extractor-v2"
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03968978",
        "aact_title": "Tezepelumab Home Use Study",
        "aact_acronym": "PATH-HOME",
        "start_date": "2019-05-21",
        "primary_completion_date": "2020-06-05",
        "aact_intvs": [
          "Tezepelumab (APFS)",
          "Tezepelumab (AI)"
        ],
        "aact_conditions": [
          "asthma"
        ],
        "pmid": "33907423",
        "pubmed_year": 2021,
        "pubmed_doi": "10.2147/JAA.S305114",
        "aact_per_arm_counts": {
          "BG000": 111,
          "BG001": 105
        },
        "aact_primary_outcome_measure": "Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "110.0"
          ],
          [
            "OG001",
            "103.0"
          ],
          [
            "OG000",
            "110.0"
          ],
          [
            "OG000",
            "2.0"
          ],
          [
            "OG000",
            "1.0"
          ],
          [
            "OG000",
            "109.0"
          ],
          [
            "OG001",
            "105.0"
          ],
          [
            "OG000",
            "111.0"
          ],
          [
            "OG001",
            "102.0"
          ],
          [
            "OG001",
            "104.0"
          ]
        ]
      }
    }
  ],
  "gate_summary": {
    "A_aact_exists": 4,
    "B_drug_in_intvs": 4,
    "C_condition_in_aact": 3,
    "D_pmid_topic_match": 4,
    "E_two_arms": 4,
    "F_primary_outcome_known": 4
  },
  "n_total": 4,
  "n_pass_all": 3,
  "pass_rate": 0.75,
  "verdict": "VIABLE"
}