NCT01086384

Asthma Exacerbation Study

Completed Phase 3 Results posted Last updated 24 January 2018

What this trial tests

Phase 3 trial testing Fluticasone Furoate/GW642444 in Asthma in 2,020 participants. Completed in 15 September 2011.

Timeline

22 February 2010

Primary endpoint
1 September 2011

15 September 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	2,020
Start date	22 February 2010
Primary completion	1 September 2011
Estimated completion	15 September 2011
Sites	183 locations across Japan, Russia, Ukraine, Germany, Poland, Mexico, Philippines, Argentina

Drugs / interventions tested

• Fluticasone Furoate/GW642444 — full drug profile →
• Fluticasone furoate (FLUTICASONE FUROATE) — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

12 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With 1 or More Severe Asthma Exacerbations Primary · Baseline to Follow-up (up to 76 weeks of treatment)

Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportion

Group	Value	95% CI
FF 100 µg	186
FF/VI 100/25 µg	154

Number of Severe Asthma Exacerbations Secondary · Baseline to Follow-up (up to 76 weeks of treatment)

A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.

Group	Value	95% CI
FF 100 µg	271
FF/VI 100/25 µg	200

Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36 Secondary · Baseline and Week 36

Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.

Group	Value	95% CI
FF 100 µg	0.265	± 0.014
FF/VI 100/25 µg	0.348	± 0.014

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FF 100 µg

Serious: 29/1010 (3%)

Deaths: —

FF/VI 100/25 µg

Serious: 41/1009 (4%)

Deaths: —

Serious adverse events (56 terms)

Reaction	System	FF 100 µg	FF/VI 100/25 µg
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonia	Infections and infestations	—	—
Nasal polyps	Respiratory, thoracic and mediastinal disorders	—	—
Pleurisy	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Anal abscess	Infections and infestations	—	—
Appendicitis	Infections and infestations	—	—
Bronchitis bacterial	Infections and infestations	—	—
Chronic sinusitis	Infections and infestations	—	—
Labyrinthitis	Infections and infestations	—	—
Lobar pneumonia	Infections and infestations	—	—
Meningitis viral	Infections and infestations	—	—
Otitis media	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Skin infection	Infections and infestations	—	—
Subcutaneous abscess	Infections and infestations	—	—
Tracheobronchitis	Infections and infestations	—	—
Viral infection	Infections and infestations	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Osteochondroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Renal cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Subarachnoid haemorrhage	Nervous system disorders	—	—
Cerebrovascular accident	Nervous system disorders	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	FF 100 µg	FF/VI 100/25 µg
Headache	Nervous system disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Bronchitis	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Influenza	Infections and infestations	—	—
Sinusitus	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Asthma, Pneumonia, Nasal polyps, Pleurisy, Pulmonary embolism, Anal abscess, Appendicitis, Bronchitis bacterial.

Data from ClinicalTrials.gov NCT01086384 adverse events section.

Sponsor's own description

This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone.
   Bateman ED, O'Byrne PM, Busse WW, Lötvall J, et al · · 2014 · cited 57× · PMID 24253831 · DOI 10.1136/thoraxjnl-2013-203600
2. GLCCI1 rs37973 does not influence treatment response to inhaled corticosteroids in white subjects with asthma.
   Hosking L, Bleecker E, Ghosh S, Yeo A, et al · · 2014 · cited 29× · PMID 24131825 · DOI 10.1016/j.jaci.2013.08.024
3. Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy.
   Albertson TE, Bullick SW, Schivo M, Sutter ME. · · 2016 · cited 7× · PMID 28008228 · DOI 10.2147/dddt.s113573
4. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma.
   O'Byrne PM, Jacques L, Goldfrad C, Kwon N, et al · · 2016 · cited 7× · PMID 27881132 · DOI 10.1186/s12931-016-0473-x
5. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials.
   Gross AS, Goldfrad C, Hozawa S, James MH, et al · · 2015 · cited 6× · PMID 26704701 · DOI 10.1186/s12890-015-0159-z
6. Addition of long-acting beta2 agonists or long-acting muscarinic antagonists versus doubling the dose of inhaled corticosteroids (ICS) in adolescents and adults with uncontrolled asthma with medium dose ICS: a systematic review and network meta-analysis.
   Oba Y, Anwer S, Patel T, Maduke T, et al · · 2023 · cited 5× · PMID 37602534 · DOI 10.1002/14651858.cd013797.pub2