An observational study in Pulmonary Disease, Chronic Obstructive, Bronchospasm and Influenza, Human, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by GlaxoSmithKline · Observational
In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza.
SPECIFIC AIMS
METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like illness and respiratory outcomes in persons for whom some household members (index cases) have had a medical visit associated with a diagnosis of influenza. The exposed individuals to the index case will be categorized into one of four cohorts according to whether the exposed person received prophylactic Relenza or no antiviral treatment and by whether the index family member with a diagnosis of influenza received antiviral treatment.
Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing disease in susceptible family members, and the total effect of disease reduction when both index cases and susceptible family members are treated will be obtained from different comparisons between cohorts, as outlined below.
The research will cover the first three influenza seasons during which Relenza has been indicated for prophylactic use in the United States. These will be from October through April of 2006-2009.
***Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.***
This analysis will use the i3 Ingenix proprietary National Health Information (NHI) database, containing claims and enrollment data back to 1993, with the opportunity to link patient and physician survey data to pharmacy and medical claims, and clinical laboratory results. These data are use for a wide range of pharmacoepidemiologic, healthcare utilization, and economic analyses. In addition to data derived from affiliated health plans, data from large, national employer groups are also stored in the database. The data undergo regular audits and quality control procedures. The accessible information includes demographics, pharmacy use, and all medical and facilities claims, which provide data on services, procedures, and their accompanying diagnoses. Underlying information is geographically diverse across the US, and is updated frequently. The insured population from which the database draws the data comprises approximately 4 percent of the US population. The data used for analysis is de-identified.
Study Cohorts From October 2006 through April 2009, we will count patients receiving prophylactic Relenza, defined as a dispensing of Relenza to a person who meets two criteria: (1) not having had a diagnosis of influenza associated with medical care on the day of dispensing or in the preceding three days, and (2) a household member has had a diagnosis of influenza associated with medical care on the day of the index dispensing or within the preceding three days. "Household members" will be defined operationally as persons within the RDM sharing a common family identifier and address.
We will assemble the study cohorts for the 3 influenza seasons running from October 2006 through April 2009. Cohort membership is based on the treatment an individual receives and the nature of household exposure.
Exclusion criteria include:
Observation begins for the prophylaxis and treated patients on the day following Relenza dispensing and for the non-prophylaxis and untreated patients on the third day following their medical visit, and continues for a total of 30 days.
Covariates For each individual we will identify age, sex, medical conditions requiring care in the six months preceding cohort entry from insurance claims for health services. Medical conditions requiring care will be defined at the 3-digit ICD9 diagnostic level.
Outcomes We will identify medical visits and hospitalizations with influenza-like illness and respiratory disease in the 30 days following cohort entry.
Analysis
Within categories of age of 5-14, 15-44, 45-64 and 65+ years, we will tabulate:
For each outcome we will estimate the following antiviral efficacy measures detailed in Halloran's analysis of clinical trials data [Halloran, 2007]. The first two effects below will be standardization to the age distribution of all persons receiving prophylactic Relenza;
Total Effect of Relenza Prophylaxis and Treatment: Risk in Cohort 2 is less than Risk in Cohort 3 Prophylaxis patient with treated index case vs. patient without prophylaxis with untreated index
We will calculate the following effect estimate with standardization to the age distribution of untreated persons.
Using binomial regression and a linear risk model, we will obtain adjusted estimates for Direct Effect, Total Effect, and Protective Effect, defined as above, adjusted for age group, sex, and any diagnosis with a prevalence of at least 10 percent in the cohorts combined.
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The study will use data from the NHI database which includes only those individuals who have both medical and pharmacy benefits, and therefore captures most outpatient prescription drug exposures and health provider encounters. From October 2006 through April 2009, we will count patients receiving prophylactic Relenza, defined as a dispensing of Relenza to a person who meets 2 criteria: (1) not having had a diagnosis of influenza associated with medical care on the day of dispensing or in the preceding 3 days, and (2) a household member has had a diagnosis of influenza associated with medical care on the day of the prophylactic dispensing or within the preceding 3 days. Household members will be defined as persons within the NHI database sharing a common family identifier code.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Individuals are eligible to be included in the prophylaxis with untreated index cohort if they are at least 5 years old and have at least 6 months of continuous enrollment, and 1. Received a dispensing of Relenza (HICL=020398 or HCPCS = G9018 or G9034), and 2. Have no diagnosis of influenza (ICD-9 487.xx) on the day of Relenza dispensing or in the 3 preceding days, and 3. A household member (index case) with the same family identifier code has had a medical visit (outpatient, inpatient or emergency room (ER) visit) in the 3 days preceding or the day of the Relenza dispensing with a diagnosis of influenza (ICD-9 487.xx), and 4. The household member (index case) has not received any antiviral therapy (oseltamivir (Tamiflu), rimantadine, amantadine, and zanamivir (Relenza)) on the day of or the day after the index case's medical visit associated with a diagnosis of influenza.
Drug: Receiving a prescription of Relenza for prophylaxis
Individuals are eligible to be included in the prophylaxis with treated index cohort if they are at least 5 years old, have 6 months continuous enrollment and 1. Received a dispensing of Relenza (HICL=020398 or HCPCS = G9018 or G9034), and 2. Have no diagnosis of influenza (ICD-9 487.xx) on the day of Relenza dispensing or in the 3 preceding days, and 3. A household member (index case) with the same family ID variable has had a medical visit (outpatient, inpatient or ER visit) in the 3 days preceding or the day of the Relenza dispensing with a diagnosis of influenza (ICD-9 487.xx), and 4. The household member (index case) has received any antiviral therapy (oseltamivir (Tamiflu), rimantadine, amantadine, and zanamivir (Relenza)) on the day of or the day after the index case's medical visit associated with a diagnosis of influenza.
Drug: Receiving a prescription of Relenza for prophylaxis
Individuals are eligible to be included in the no prophylaxis with untreated index cohort if they are at least 5 years old, have 6 months continuous enrollment and 1. Have not received a dispensing of Relenza (HICL=020398 or HCPCS = G9018 or G9034) within 3 days following the date on which 2. A household member (index case) with the same family ID variable has had a medical visit (outpatient, inpatient or ER visit) with a diagnosis of influenza (ICD-9 487.xx), and 3. The household member (index case) has not received any antiviral therapy (oseltamivir (Tamiflu), rimantadine, amantadine, and zanamivir (Relenza)) on the day of or the day after the index case's medical visit associated with a diagnosis of influenza.
Other: No prophylaxis with Relenza
Individuals are eligible to be included in the no prophylaxis with treated index cohort if they are at least 5 years old, have 6 months continuous enrollment and 1. Have not received a dispensing of Relenza(HICL=020398 or HCPCS = G9018 or G9034) within 3 days following the date on which 2. A household member (index case) with the same family ID variable has had a medical visit (outpatient, inpatient or ER visit) with a diagnosis of influenza (ICD-9 487.xx), and 3. The household member (index case) has received zanamivir (Relenza) on the day of or the day after the index case's medical visit associated with a diagnosis of influenza
Other: No prophylaxis with Relenza
Receiving a prescription of Relenza for prophylaxis
No prophylaxis with Relenza
Number of Patients With Influenza
The frequency of influenza among the four cohorts was measured.
Time frame: 2006-2009
Number of Patients With Asthma
The frequency of asthma among the four cohorts was measured.
Time frame: 2006-2009
Number of Patients With Pneumonia
The frequency of pneumonia among the four cohorts was measured..
Time frame: 2006-2009
Number of Patients With Bronchitis
The frequency of bronchitis among the four cohorts was measured.
Time frame: 2006-2009
Number of Patients With Any Respiratory Diagnosis
The frequency of any respiratory diagnosis among the four cohorts was measured.
Time frame: 2006-2009
Number of Patients With Respiratory Outcomes
Time frame: Baseline
Number of Participants Experiencing Hospitalization or Death Due to Influenza
The frequency of hospitalization and death in the study population was analyzed.
Time frame: Baseline
| Milestone | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Started | 257 | 1007 | 163716 | 6725 |
| Completed | 257 | 1007 | 163716 | 6725 |
| Not completed | 0 | 0 | 0 | 0 |
The frequency of influenza among the four cohorts was measured.
| patients | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Influenza | 3 | 10 | 2539 | 93 |
| No Influenza | 254 | 997 | 161177 | 6632 |
The frequency of asthma among the four cohorts was measured.
| patients | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Asthma | 1 | 5 | 1488 | 54 |
| No Asthma | 256 | 1002 | 162228 | 6671 |
The frequency of pneumonia among the four cohorts was measured..
| patients | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Pneumonia | 2 | 1 | 541 | 16 |
| No Pneumonia | 255 | 1006 | 163175 | 6709 |
The frequency of bronchitis among the four cohorts was measured.
| patients | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Bronchitis | 8 | 15 | 2572 | 96 |
| No Bronchitis | 249 | 992 | 161144 | 6629 |
The frequency of any respiratory diagnosis among the four cohorts was measured.
| patients | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Respiratory Diagnosis | 16 | 50 | 10166 | 420 |
| No Respiratory Diagnosis | 241 | 957 | 153550 | 6305 |
| patients | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Influenza | 3 | 10 | 2539 | 93 |
| Asthma | 1 | 5 | 1488 | 54 |
| Chronic obstructive pulmonary disease (COPD) | 0 | 0 | 153 | 3 |
| Exacerbation of COPD | 0 | 0 | 34 | 0 |
| Bronchospasm | 0 | 0 | 110 | 5 |
| Pneumonia | 2 | 1 | 541 | 16 |
| Bronchitis | 8 | 15 | 2572 | 96 |
| Sinusitis | 1 | 20 | 2708 | 140 |
| Otitis media | 2 | 4 | 1582 | 64 |
| Any of the above | 16 | 50 | 10166 | 420 |
The frequency of hospitalization and death in the study population was analyzed.
| patients | Cohort 1: Prophylaxis With Untreated Index | Cohort 2: Prophylaxis With Treated Index | Cohort 3: Untreated With Untreated Index | Cohort 4: Untreated With Treated Index |
|---|---|---|---|---|
| Hospitalization | 0 | 6 | 1063 | 41 |
| Death | 0 | 0 | 4 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Prophylaxis With Untreated Index | — | — | — |
| Cohort 2: Prophylaxis With Treated Index | — | — | — |
| Cohort 3: Untreated With Untreated Index | — | — | — |
| Cohort 4: Untreated With Treated Index | — | — | — |
| Age, Customized(Participants) | All Patients Included in the Analysis |
|---|---|
| 5-14 years | 47670 |
| 15-44 years | 85640 |
| 45-64 years | 37119 |
| >=65 years | 1276 |
| Sex: Female, Male(Participants) | All Patients Included in the Analysis |
|---|---|
| Female | 84162 |
| Male | 87543 |
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