Pulmonary Disease, Chronic ObstructiveNCT01156701
Prophylactic Efficacy of Relenza Against Influenza A and B
An observational study of Pulmonary Disease, Chronic Obstructive and Bronchospasm, run by GlaxoSmithKline.
Trial summary
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 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Bronchospasm, Influenza, Human
- What is being tested?
- Receiving a prescription of Relenza for prophylaxis and No prophylaxis with Relenza
- How many people
- 171,705 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to May 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 5 years or older
- At least 6 months of continuous follow up time
- Received Relenza without a diagnosis of influenza
Who cannot join
- Sex unknown
- Year of birth is missing
- Date of dispensing or service date preceded the year of birth
- Age at index date is less than 5 years
- Not enrolled in the health plan for 6 months prior to the study entry date
About this study
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
Read more
- Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i.e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis.
- If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i.e., index cases).
- If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis).
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.
Read the detailed description
*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:
- Sex unknown
- Year of birth is missing or where the date of dispensing or service date preceded the year of birth
- Age at index date is less than 5 years
- Not enrolled in the health plan for 6 months prior to the study entry date
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:
- the number of individuals in each of four cohorts (cohorts defined below)
- the number of medical visits for influenza-like illness and respiratory illness in the 30-day follow-up period
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;
- Direct Effect of Relenza Prophylaxis: Risk in Cohort 1 is less than Risk in Cohort 3 Prophylaxis patient with untreated index case vs patient without prophylaxis with untreated index
- 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.
- Protective Effect of Relenza Prophylaxis on Susceptible: Risk in Cohort 2 is less than Risk in Cohort 4 Prophylaxis patient with treated index case vs. patient without prophylaxis with treated index
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Bronchospasm, Influenza, Human, Asthma, Respiratory Disease, Exacerbation of COPD
- Being tested
- Receiving a prescription of Relenza for prophylaxis, No prophylaxis with Relenza
- Keywords
- Influenza, Zanamivir, Influenza prophylaxis, Relenza
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchial Spasm, Influenza, Human, Asthma, Respiration Disorders, Bronchitis, Pneumonia, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving a prescription of Relenza for prophylaxisDrug
Receiving a prescription of Relenza for prophylaxis
No prophylaxis with RelenzaOther
No prophylaxis with Relenza
| Study group | Role | What they receive |
|---|---|---|
| Cohort1: Prophylaxis with untreated index | 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. Receives: Drug: Receiving a prescription of Relenza for prophylaxis | |
| Cohort2: Prophylaxis with treated index | 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. Receives: Drug: Receiving a prescription of Relenza for prophylaxis | |
| Cohort3: No prophylaxis with untreated index | 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. Receives: Other: No prophylaxis with Relenza | |
| Cohort4: No prophylaxis with treated index | 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 Receives: Other: No prophylaxis with Relenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Influenza
The frequency of influenza among the four cohorts was measured.
Measured: 2006-2009
Secondary outcomes (4)
Number of Patients With Asthma
The frequency of asthma among the four cohorts was measured.
Measured: 2006-2009
Number of Patients With Pneumonia
The frequency of pneumonia among the four cohorts was measured..
Measured: 2006-2009
Number of Patients With Bronchitis
The frequency of bronchitis among the four cohorts was measured.
Measured: 2006-2009
Number of Patients With Any Respiratory Diagnosis
The frequency of any respiratory diagnosis among the four cohorts was measured.
Measured: 2006-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 171,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156701
- Sponsor's protocol ID
- 113502
- Other IDs
- WEUSRTP2058, EPI40499
- Status last verified
- May 2017
- First submitted
- 22 Apr 2010
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kandace Amend, Vani Vannappagari, Maria Wood-Armany, Rob Gately, John Seeger; Effectiveness of Zanamivir Prophylaxis for Influenza.26th ICPE: International Conference on Pharmacoepidemiology & Therapeutic Risk Management August 19-22, 2010, Brighton, UK
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Efficacy of Relenza Against Influenza A and B
- ClinicalTrials.gov ID
- NCT01156701
- Acronym / sponsor ID
- 113502
- Conditions
- Pulmonary Disease, Chronic Obstructive, Bronchospasm, Influenza, Human, Asthma, Respiratory Disease, Exacerbation of COPD
- Keywords
- Influenza, Zanamivir, Influenza prophylaxis, Relenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171,705 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 4 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i.e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis.
- If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i.e., index cases).
- If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis).
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.
Detailed description
*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:
- Sex unknown
- Year of birth is missing or where the date of dispensing or service date preceded the year of birth
- Age at index date is less than 5 years
- Not enrolled in the health plan for 6 months prior to the study entry date
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:
- the number of individuals in each of four cohorts (cohorts defined below)
- the number of medical visits for influenza-like illness and respiratory illness in the 30-day follow-up period
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;
- Direct Effect of Relenza Prophylaxis: Risk in Cohort 1 is less than Risk in Cohort 3 Prophylaxis patient with untreated index case vs patient without prophylaxis with untreated index
- 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.
- Protective Effect of Relenza Prophylaxis on Susceptible: Risk in Cohort 2 is less than Risk in Cohort 4 Prophylaxis patient with treated index case vs. patient without prophylaxis with treated index
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.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort1: Prophylaxis with untreated index | – | Drug: Receiving a prescription of Relenza for prophylaxisIndividuals 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. |
| Cohort2: Prophylaxis with treated index | – | Drug: Receiving a prescription of Relenza for prophylaxisIndividuals 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. |
| Cohort3: No prophylaxis with untreated index | – | Other: No prophylaxis with RelenzaIndividuals 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. |
| Cohort4: No prophylaxis with treated index | – | Other: No prophylaxis with RelenzaIndividuals 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 5 years or older
- At least 6 months of continuous follow up time
- Received Relenza without a diagnosis of influenza
Key exclusion criteria (5 listed)
- Sex unknown
- Year of birth is missing
- Date of dispensing or service date preceded the year of birth
- Age at index date is less than 5 years
- Not enrolled in the health plan for 6 months prior to the study entry date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receiving a prescription of Relenza for prophylaxisReceiving a prescription of Relenza for prophylaxis | Drug | Cohort1: Prophylaxis with untreated index, Cohort2: Prophylaxis with treated index |
| No prophylaxis with RelenzaNo prophylaxis with Relenza | Other | Cohort3: No prophylaxis with untreated index, Cohort4: No prophylaxis with treated index |
Primary outcome
Number of Patients With Influenza
Time frame: 2006-2009
The frequency of influenza among the four cohorts was measured.
4 secondary outcomes
Number of Patients With Asthma
Time frame: 2006-2009
Number of Patients With Pneumonia
Time frame: 2006-2009
Number of Patients With Bronchitis
Time frame: 2006-2009
Number of Patients With Any Respiratory Diagnosis
Time frame: 2006-2009
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationKandace Amend, Vani Vannappagari, Maria Wood-Armany, Rob Gately, John Seeger; Effectiveness of Zanamivir Prophylaxis for Influenza.26th ICPE: International Conference on Pharmacoepidemiology & Therapeutic Risk Management August 19-22, 2010, Brighton, UK
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Bronchospasm, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Influenza (time frame: 2006-2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01156701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.