Prophylactic Efficacy of Relenza Against Influenza A and B

NCT01156701 | Completed Results

• 3 other identifiers: 113502WEUSRTP2058EPI40499
• Study Type: observational
• Target: 171,705
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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).

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchospasm; Influenza, Human; Asthma; Respiratory Disease; Exacerbation of COPD; Bronchitis; Otitis Maedia; Pneumonia; Sinusitis

Keywords

Influenza; Zanamivir; Influenza prophylaxis; Relenza

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Influenza

  The frequency of influenza among the four cohorts was measured.

  2006-2009

Secondary Outcomes (4)

• Number of Patients With Asthma

  2006-2009

• Number of Patients With Pneumonia

  2006-2009

• Number of Patients With Bronchitis

  2006-2009

• Number of Patients With Any Respiratory Diagnosis

  2006-2009

Other Outcomes (2)

• Number of Patients With Respiratory Outcomes

  Baseline

• Number of Participants Experiencing Hospitalization or Death Due to Influenza

  Baseline

Study Arms (4)

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

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

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

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

Interventions

Receiving a prescription of Relenza for prophylaxis DRUG

Receiving a prescription of Relenza for prophylaxis

Cohort1: Prophylaxis with untreated index; Cohort2: Prophylaxis with treated index

No prophylaxis with Relenza OTHER

No prophylaxis with Relenza

Cohort3: No prophylaxis with untreated index; Cohort4: No prophylaxis with treated index

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchial Spasm; Influenza, Human; Asthma; Respiration Disorders; Bronchitis; Pneumonia; Sinusitis

Interventions

Zanamivir

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Paranasal Sinus Diseases; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Sialic Acids; Neuraminic Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amino Sugars; Carbohydrates

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: July 5, 2010
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 30, 2017
• Results First Posted: March 4, 2011

Record last verified: 2017-05