{
    "info": {
        "nct_id": "NCT03564548",
        "official_title": "Inhaled PPP001 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: a Randomized, Open Label, Crossover, Comparison Study",
        "inclusion_criteria": "1. Written informed consent.\n2. Adult male and female subjects at least 18 years of age.\n3. Subject agrees to follow the protocol.\n4. Confirmed diagnosis of cancer with life expectancy of more than 3 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n5. If currently receiving chemotherapy and/or radiotherapy treatment, subjects must be on a stable regimen for at least one month (30 days ± 2 days) prior to screening.\n6. Background cancer pain stable (pain <4/10 on numeric rating scale) and adequately controlled with long-acting oral morphine, oxycodone, hydromorphone, hydrocodone, or meperidine.\n7. Subject receiving at least 30 mg of oral morphine equivalent daily doses (MEDD) for both background and breakthrough cancer pain.\n8. The subject is currently taking chronic treatment with opiod analgesic but still has a clinical diagnosis of breakthrough cancer pain with <3 episodes per day but >3 episodes per week.\n9. The subject is using only oral morphine sulfate for breakthrough opioid analgesia.\n10. Normal cognitive status according to MiniCog.\n11. The subject is able to perform deep inhalations with FEV1 more than 60%.\n12. Ability to read and respond to questions in English.\n13. A female subject must meet one of the following criteria:\n\n    If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.\n\n    If of non-childbearing potential - should be surgically sterile or in a menopausal state\n14. A male subject with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Adult male and female subjects at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Adult male and female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject agrees to follow the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Subject agrees to follow the protocol.",
                    "criterion": "protocol adherence",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Confirmed diagnosis of cancer with life expectancy of more than 3 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of more than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. If currently receiving chemotherapy and/or radiotherapy treatment, subjects must be on a stable regimen for at least one month (30 days ± 2 days) prior to screening.",
            "criterions": [
                {
                    "exact_snippets": "currently receiving chemotherapy",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 32,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "currently receiving ... radiotherapy treatment",
                    "criterion": "radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 32,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Background cancer pain stable (pain <4/10 on numeric rating scale) and adequately controlled with long-acting oral morphine, oxycodone, hydromorphone, hydrocodone, or meperidine.",
            "criterions": [
                {
                    "exact_snippets": "Background cancer pain stable",
                    "criterion": "background cancer pain",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pain <4/10 on numeric rating scale",
                    "criterion": "pain level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "/10"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately controlled with long-acting oral morphine, oxycodone, hydromorphone, hydrocodone, or meperidine",
                    "criterion": "pain control",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "long-acting oral morphine",
                                "oxycodone",
                                "hydromorphone",
                                "hydrocodone",
                                "meperidine"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subject receiving at least 30 mg of oral morphine equivalent daily doses (MEDD) for both background and breakthrough cancer pain.",
            "criterions": [
                {
                    "exact_snippets": "Subject receiving at least 30 mg of oral morphine equivalent daily doses (MEDD)",
                    "criterion": "oral morphine equivalent daily doses (MEDD)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for both background and breakthrough cancer pain",
                    "criterion": "cancer pain",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "background",
                                "breakthrough"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The subject is currently taking chronic treatment with opiod analgesic but still has a clinical diagnosis of breakthrough cancer pain with <3 episodes per day but >3 episodes per week.",
            "criterions": [
                {
                    "exact_snippets": "currently taking chronic treatment with opiod analgesic",
                    "criterion": "chronic opioid analgesic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical diagnosis of breakthrough cancer pain",
                    "criterion": "breakthrough cancer pain diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "<3 episodes per day",
                    "criterion": "breakthrough cancer pain episodes per day",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "episodes per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": ">3 episodes per week",
                    "criterion": "breakthrough cancer pain episodes per week",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "episodes per week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The subject is using only oral morphine sulfate for breakthrough opioid analgesia.",
            "criterions": [
                {
                    "exact_snippets": "The subject is using only oral morphine sulfate for breakthrough opioid analgesia.",
                    "criterion": "breakthrough opioid analgesia",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "oral morphine sulfate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Normal cognitive status according to MiniCog.",
            "criterions": [
                {
                    "exact_snippets": "Normal cognitive status according to MiniCog",
                    "criterion": "cognitive status",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. The subject is able to perform deep inhalations with FEV1 more than 60%.",
            "criterions": [
                {
                    "exact_snippets": "The subject is able to perform deep inhalations",
                    "criterion": "ability to perform deep inhalations",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "FEV1 more than 60%",
                    "criterion": "FEV1",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Ability to read and respond to questions in English.",
            "criterions": [
                {
                    "exact_snippets": "Ability to read ... in English.",
                    "criterion": "ability to read in English",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Ability to ... respond to questions in English.",
                    "criterion": "ability to respond to questions in English",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. A female subject must meet one of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "female subject",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.",
            "criterions": [
                {
                    "exact_snippets": "If of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use one of the accepted contraceptive regimens",
                    "criterion": "use of contraceptive regimens",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from at least 28 days prior to the first drug administration",
                    "criterion": "contraceptive regimen duration before drug administration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study",
                    "criterion": "contraceptive regimen duration during study",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "entire study period"
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 60 days after the last dose",
                    "criterion": "contraceptive regimen duration after last dose",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "If of non-childbearing potential - should be surgically sterile or in a menopausal state",
            "criterions": [
                {
                    "exact_snippets": "non-childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "state",
                            "expected_value": "non-childbearing"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "state",
                            "expected_value": "sterile"
                        }
                    ]
                },
                {
                    "exact_snippets": "menopausal state",
                    "criterion": "menopausal state",
                    "requirements": [
                        {
                            "requirement_type": "state",
                            "expected_value": "menopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. A male subject with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.",
            "criterions": [
                {
                    "exact_snippets": "A male subject with sexual partners who are pregnant, possibly pregnant, or who could become pregnant",
                    "criterion": "sexual partners' pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "pregnant",
                                "possibly pregnant",
                                "could become pregnant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must be surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use one of the accepted contraceptive regimens",
                    "criterion": "use of contraceptive regimens",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from first drug administration until 3 months after the last drug administration",
                    "criterion": "duration of contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from first drug administration until 3 months after the last drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}