Phase 4 N=221 Treatment

Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00363480 ↗

Enrolled (actual)

221

Serious AEs

0.4%

Results posted

Mar 2018

Primary outcome: Primary: Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12 — 33.5; 64.1 Percentage — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Salmeterol/Fluticasone 50/250 mcg (Drug); Salbutamol 100 mcg (Drug); DISKUS™ powder inhalers (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Sep 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12	33.5; 64.1	<0.0001 sig
SECONDARY Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12	32; 139	—
SECONDARY Change From Baseline in Mean ACT Score at Visit 6	5.0	—
SECONDARY Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12	65; 29	—
SECONDARY Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)	0.83	—
SECONDARY Correlation of Change in AQLQ Score and Change in ACT Score	0.522	—
SECONDARY Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12	0.133; 0.212; 0.181	—
SECONDARY Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12	7.798	—
SECONDARY Change From Baseline in Mean 24-hour Symptom Score at Week 12	-0.590	—
SECONDARY Change From Baseline in Number of Additional Usage of Salbutamol at Week 12	-0.933	—
SECONDARY Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12	7.228	—
SECONDARY Number of Participants With Emergency Visits Due to Asthma	13; 10; 2; 1; 0	—
SECONDARY Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment	4	—
SECONDARY Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE	76; 1	—
SECONDARY Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	0.8; -0.7; 0.2; 0.2; -0.2; 0.6	—
SECONDARY Assessment of Tolerability by Change From Baseline of Pulse Rate	1.0; -0.2; 0.6	—
SECONDARY Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements	—	—

Summary

The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients. The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.

Eligibility Criteria

Inclusion criteria

Diagnosis of asthma
Reversibility >12% after inhalation of 200 µg Salbutamol
willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis
80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria

Exclusion criteria

Change of asthma medication during the last 4 weeks
Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months
upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period
Non compliance with use of Discus, PEF-meter and incomplete diary card data

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00363480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.