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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01475721
Other study ID # 115359
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 18, 2011
Est. completion date June 23, 2015

Study information

Verified date August 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.


Description:

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.


Recruitment information / eligibility

Status Completed
Enrollment 11751
Est. completion date June 23, 2015
Est. primary completion date June 23, 2015
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Provided consent to participate in the study

- Male or female, 12 years of age and older

- Clinical diagnosis of asthma for at least 1 year prior to the randomization

- Clinic PEF of greater than or equal to 50% of predicted normal value

- Subject must be appropriately using one of the treatments for asthma listed in the protocol

- Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler

- Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:

- requiring treatment with systemic corticosteroids

- an asthma-related hospitalization

Exclusion Criteria:

- History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support

- Concurrent respiratory disease other than asthma

- Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.

- Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine

- Presence of a bacterial or viral respiratory infection that is not resolved at randomization

- An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization

- More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization

- Subject must not meet unstable asthma severity criteria as listed in the protocol

- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)

- Pregnancy, breast-feeding or planned pregnancy during the study

- A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ADVAIR 100/50mcg
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
ADVAIR 500/50mcg
fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months
FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
FLOVENT 500mcg
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months

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Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline Parexel

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  Germany,  Hungary,  Indonesia,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a =24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95. From Day 1 up to 26 weeks
Primary Number of Participants Experiencing at Least One Asthma Exacerbation An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. From Day 1 up to 26 weeks
Secondary Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death Hospitalization was defined as an inpatient stay or a =24-hour stay in an observation area in an emergency department or other equivalent facility. From Day 1 up to 26 weeks
Secondary Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. From Day 1 up to 26 weeks
Secondary Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months. From Day 1 up to 26 weeks
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