NCT00363480

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

Completed Phase 4 Results posted Last updated 9 March 2018

What this trial tests

Phase 4 trial testing Salmeterol/Fluticasone 50/250 mcg in Asthma in 221 participants. Completed in 14 September 2007.

Timeline

17 May 2006

Primary endpoint
1 September 2007

14 September 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	221
Start date	17 May 2006
Primary completion	1 September 2007
Estimated completion	14 September 2007
Sites	32 locations across Germany

Drugs / interventions tested

• Salmeterol/Fluticasone 50/250 mcg — full drug profile →
• Salbutamol 100 mcg — full drug profile →
• DISKUS™ powder inhalers

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 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.

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 Primary · Week 9 to Week 12

A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score \>1 (Range: 0= None to 5= severe), rescue salbutamol use on \<= 2 days and at most 4 occasions per week, and a morning peak flow \>= 80% of the predicted value on each day per week. All of the criteria which includes no night-time awakenings due to asthma (diary entry), no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change are fulfilled. The total ACT score is based on a range of

GOAL

Group	Value	95% CI
SFC 50/250 mcg	33.5

ACT

Group	Value	95% CI
SFC 50/250 mcg	64.1

Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12 Secondary · Baseline (Visit 3) and Week 12

The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control. In order to derive the total ACT score, all 5 questions needed to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Baseline

Group	Value	95% CI
SFC 50/250 mcg	32

Week 12

Group	Value	95% CI
SFC 50/250 mcg	139

Change From Baseline in Mean ACT Score at Visit 6 Secondary · Baseline (Viait 3) and Week 12

The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. In order to derive the total ACT score, all 5 questions had to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Group	Value	95% CI
SFC 50/250 mcg	5.0	± 4.3

Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12 Secondary · Week 12

Well controlled or totally controlled asthma assessments were done according to the GOAL criteria. A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score \>1(Range: 0= None to 5= severe), rescue salbutamol use on \<= 2 days and at most 4 occasions per week, and morning peak flow \>= 80% of the predicted value on each day per week. All of the criteria which included no night-time awakenings due to asthma (diary entry),no emergency visits (diary entry), no exacerbations and no treatment-related adver

Well Controlled

Group	Value	95% CI
SFC 50/250 mcg	65	23 – 36

Totally Controlled

Group	Value	95% CI
SFC 50/250 mcg	29

Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ) Secondary · Baseline (Visit 3) up to Week 12

For the level of asthma control, baseline values were derived taking the last 8 weeks during the pre-treatment period prior to Visit 3 into consideration. Regarding derived variables based on the asthma diary, data from the last week prior to Visit 3 was taken. Visit 3, regarded as baseline. AQLQ has 32 questions regarding activities, emotions, symptoms, and environmental triggers. Each item values range from 1 (maximum impairment) to 7 (no impairment). A positive change from baseline score indicates improvement.

Group	Value	95% CI
SFC 50/250 mcg	0.83	± 0.91

Correlation of Change in AQLQ Score and Change in ACT Score Secondary · Week 12

Correlation between change in the AQLQ and ACT score was tabulated using the Pearson coefficient of correlation (linear correlation). The AQLQ contained 32 items in 4 domains: activity limitation, symptoms, emotional function and environmental stimuli. Scores for the domains as well as the overall score were scaled within a range of 1 (worst) to 7 (best).

Group	Value	95% CI
SFC 50/250 mcg	0.522

Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12 Secondary · Baseline (Visit 3) up to Week 12

FEV1, an amount of air exhaled by a person during a forced breath in one second. FEV1 assessed at Visit 1 and at Visits 3, 4, 5, 6. Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.

Week 4

Group	Value	95% CI
SFC 50/250 mcg	0.133	± 0.320

Week 8

Group	Value	95% CI
SFC 50/250 mcg	0.212	± 0.359

Week 12

Group	Value	95% CI
SFC 50/250 mcg	0.181	± 0.372

Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12 Secondary · Baseline (Visit 3) and Week 12

PEF, a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. The mean morning PEF evaluated by means of the data documented in the asthma diaries. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Group	Value	95% CI
SFC 50/250 mcg	7.798	± 10.302

Change From Baseline in Mean 24-hour Symptom Score at Week 12 Secondary · Baseline (Visit 3) and Week 12

The various symptoms like wheezing, shortness of breath, coughing and chest tightness were assessed by the participants every morning using a symptom score scale which ranged from 0 (no symptoms during the past 24 hours) to 5 (symptoms so severe that participant could not go to work or carry out other normal daily activities). Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Group	Value	95% CI
SFC 50/250 mcg	-0.590	± 0.948

Change From Baseline in Number of Additional Usage of Salbutamol at Week 12 Secondary · Baseline (Visit 3) and week 12

Salbutamol was given as a rescue medicine, used on \<= 2 days and at most 4 occasions per week. Change from baseline value was calculated by subtracting the baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Group	Value	95% CI
SFC 50/250 mcg	-0.933	± 1.331

Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12 Secondary · Baseline (Visit 3) and week 12

Number of nights with no night time awakening were recorded at Week 12. Baseline was the last corresponding time period immediately prior to Visit 3.

Group	Value	95% CI
SFC 50/250 mcg	7.228	± 24.921

Number of Participants With Emergency Visits Due to Asthma Secondary · Up to week 12

Frequencies of emergency visits per participant were recorded during treatment period. Only the participants at risk were considered when calculating the incidence rates.

At least 1 day

Group	Value	95% CI
SFC 50/250 mcg	13

1 day

Group	Value	95% CI
SFC 50/250 mcg	10

2 days

Group	Value	95% CI
SFC 50/250 mcg	2

3-4 days

Group	Value	95% CI
SFC 50/250 mcg	1

5-9 days

Group	Value	95% CI
SFC 50/250 mcg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 12. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SFC 50/250 mcg

Serious: 1/221 (0%)

Deaths: 1/221

Serious adverse events (2 terms)

Reaction	System	SFC 50/250 mcg
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Other adverse events (50 terms — click to expand)

Reaction	System	SFC 50/250 mcg
Headache	Nervous system disorders	—
Nasopharyngitis	Infections and infestations	—
Bronchitis	Infections and infestations	—
Asthma	Respiratory, thoracic and mediastinal disorders	—
Respiratory tract infection	Infections and infestations	—
Sinusitis	Infections and infestations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Toothache	Gastrointestinal disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Ear pain	Ear and labyrinth disorders	—
Candidiasis	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—
Angina pectoris	Cardiac disorders	—
Tachycardia	Cardiac disorders	—
Sudden hearing loss	Ear and labyrinth disorders	—
Vertigo	Ear and labyrinth disorders	—
Conjunctivitis allergic	Eye disorders	—
Lacrimation increased	Eye disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Gingivitis	Gastrointestinal disorders	—
Stomatitis	Gastrointestinal disorders	—
Pyrexia	General disorders	—
General physical health deterioration	General disorders	—
Local swelling	General disorders	—
Chest pain	General disorders	—
Hypersensitivity	Immune system disorders	—
Gastrointestinal infection	Infections and infestations	—
Borrelia infection	Infections and infestations	—
Oral candidiasis	Infections and infestations	—
Otitis externa	Infections and infestations	—
Acute sinusitis	Infections and infestations	—
Laryngitis	Infections and infestations	—
Rhinitis	Infections and infestations	—
Epicondylitis	Injury, poisoning and procedural complications	—
Arthropod bite	Injury, poisoning and procedural complications	—
Blood uric acid increased	Investigations	—
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Metastases to liver, Lung neoplasm malignant.

Data from ClinicalTrials.gov NCT00363480 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.