Prophylactic Efficacy of Relenza Against Influenza A and B

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01156701
First received: April 22, 2010
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

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. 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.
  2. 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).
  3. 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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Bronchospasm
Influenza, Human
Asthma
Respiratory Disease
Exacerbation of COPD
Bronchitis
Otitis Maedia
Pneumonia
Sinusitis
Drug: Receiving a prescription of Relenza for prophylaxis
Other: No prophylaxis with Relenza

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Prophylactic Efficacy of Relenza Against Influenza A and B

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Patients With Influenza [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]
    The frequency of influenza among the four cohorts was measured.


Secondary Outcome Measures:
  • Number of Patients With Asthma [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]
    The frequency of asthma among the four cohorts was measured.

  • Number of Patients With Pneumonia [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]
    The frequency of pneumonia among the four cohorts was measured..

  • Number of Patients With Bronchitis [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]
    The frequency of bronchitis among the four cohorts was measured.

  • Number of Patients With Any Respiratory Diagnosis [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]
    The frequency of any respiratory diagnosis among the four cohorts was measured.


Enrollment: 171705
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Receiving a prescription of Relenza for prophylaxis
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.
Drug: Receiving a prescription of Relenza for prophylaxis
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.
Other: No prophylaxis with Relenza
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
Other: No prophylaxis with Relenza
No prophylaxis with Relenza

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 5 years or older
  • At least 6 months of continuous follow up time
  • Received Relenza without a diagnosis of influenza

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156701

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01156701     History of Changes
Other Study ID Numbers: 113502, WEUSRTP2058, EPI40499
Study First Received: April 22, 2010
Results First Received: January 28, 2011
Last Updated: June 2, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Influenza
Zanamivir
Influenza prophylaxis
Relenza

Additional relevant MeSH terms:
Bronchial Spasm
Bronchitis
Chronic Disease
Influenza, Human
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Disease Attributes
Lung Diseases, Obstructive
Orthomyxoviridae Infections
Pathologic Processes
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Zanamivir
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014