Effect of peramivir on respiratory symptom improvement in patients with respiratory disease
- Conditions
- Influenza A and B virus infected patient with asthma, COPD, pulmonary fibrosis
- Registration Number
- JPRN-jRCTs031180322
- Lead Sponsor
- Kato Motokazu
- Brief Summary
In terms of the curve of the total score of 3 respiratory symptoms, peramivir 600mg repeated dose was not significantly effective compared with peramivir 300mg single dose and oseltamivir. Peramivir 600mg repeated dose significantly improved in sore throat and the total CAT score compared with oseltamivir. Peramivir 300mg single dose significantly improved in the area under the curve of the total respiratory symptom score, the total 3 respiratory symptom score etc. compared with oseltamivir.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 214
1) Patients aged >= 16 to < 80 years at the time of signing the informed consent / assent form. For the ages of >= 16 to <= 19 years, consent and special consideration not to leave patient alone at least for 2days has been provided by the patient`s parent / legally acceptable representative.
2) Both male and female patients.
3) Both Inpatient and outpatient.
4) Patients with influenza symptoms confirmed by all of the following,
- Fever >= 37.5 degrees (axillary) during the pre-dose examination until 12hr back from the dosing.
- Patients showing a total of >=3 points of severity scores calculated from respiratory 3 symptoms (cough#, sore throat, nasal congestion).
#: >=1 point
- At least one of the following general systemic symptoms (headache, muscle or joint pain, feverishness or chills, fatigue) associated with influenza are present with a severity of moderate (2poins).
- Influenza rapid diagnosis test positive by nasal or pharynx swab.
5) The time interval between the onset of symptoms and the pre-dose examinations (Screening) is 48 hours or less.
Notice) Onset of influenza infection is defined as the time when body temperature first elevated >= 1degree beyond normal body temperature.
6) Patients with chronic respiratory disease (bronchial asthma, COPD*, pulmonary fibrosis).
*: Including patient with emphysematous changes on CT (Computed Tomography).
1) Patients with concurrent infections at the predose examinations requiring systemic antimicrobial / antifungal therapy.
2) Patients who has medical history of conversion or other nerves symptom (loss of consciousness) in the past 2 years
3) Patients with chronic respiratory failure receiving mechanical ventilation
4) Patients who have diabetes with HbA1c (Hemoglobin A1c) : >= 10.0%, at the examination in the past 4 weeks
5) Patients with immunosuppression following organ or bone marrow transplants operated in the past 12 months.
6) Renal impairment patients receiving hemodialysis or with current creatinine clearance < 50 mL/min
7) Patient with congestive heart failure under medication
8) Patients with severe malfunction of the circulatory system, the central nerve system, the metabolic disease (thyroid, adrenal grand), hepatitis or liver cirrhosis requiring hospitalization
9) Cancer patients receiving chemotherapy, immune therapy or AIDS (Acquired immune deficiency syndrome) patients
10) Patients receiving anti-flu drugs in the past 7 days.
11) Patient receiving human immunoglobulin, anti-cytokine or colony stimulating factor (G-CSF or M-CSF) drugs.
12) Patients with known allergy, hypersensitivity or serious adverse drug reaction to 4 existing NAIs (neuraminidase inhibitors), amantadine and Baloxavir malboxil
13) Patients who already participated (allocated with drug) in the present study
14) Patients who have been exposed to an investigational drug within 90 days prior to the predose examinations or who will participate in other studies within following 2 weeks.
15) Pregnant or breastfeeding women.
16) Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve of influenza respiratory symptom score until 2 weeks
- Secondary Outcome Measures
Name Time Method -Changes from baseline in total score of 3 respiratory symptoms at each time points.<br>-Changes from baseline in total score of 7 influenza symptoms at each time points.<br>-Time to alleviation of 3 respiratory symptoms<br>-Time to alleviation of influenza symptoms<br>-Time to return to normal body temperature (< 37.0 degree, axillary)<br>-Frequency of exacerbation after administration within 2 weeks<br>-Changes from baseline in indicators of respiratory function (Total CAT score, peak flow value, saturation (SpO2)) at each time points. <br>-Changes from baseline in virus titer at each time points.<br>-Frequencies of adverse events and adverse drug reaction.