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The primary objective of this study is:
The secondary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | budesonide 400yg + terbutaline 0.4 mg as-needed |
|
| B | Active Comparator | placebo + terbutaline 0.4 mg as-needed |
|
| C | Active Comparator | placebo + budesonide/formoterol 160/4.5 yg as-needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug | 400 yg x 1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks | FEV1 | Baseline and Visit 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks | FEV1 | Baseline and 3 weeks |
| Bronchial Responsiveness to Mannitol | Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjell Larsson, Professor | AstraZeneca MC Sweden | Principal Investigator |
| Georgios Stratelis | AstraZeneca MC Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oslo | Norway | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24092567 | Derived | Lazarinis N, Jorgensen L, Ekstrom T, Bjermer L, Dahlen B, Pullerits T, Hedlin G, Carlsen KH, Larsson K. Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction. Thorax. 2014 Feb;69(2):130-6. doi: 10.1136/thoraxjnl-2013-203557. Epub 2013 Oct 3. |
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A standardized exercise test (ECT) with duration of 6 minutes, at approximately 90% of maximal aerobic capacity (as defined on Visit 1) was performed on a treadmill while breathing dry air on Visit 2. Patients with exercised induced bronchoconstriction (defined as fall in FEV1 ≥ 10% ) could be randomized on Visit 3.
On Visit 1, a total of 189 patients, aged 12-67, were enrolled at 10 study sites in 2 countries: Sweden and Norway. Of 189 enrolled patients, 66 patients were randomized and allocated to study treatment on Visit 3 (7 patients in Norway and 59 patients in Sweden).
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide/Terbutaline | Budesonide once daily and terbutaline before exercise and as needed |
| FG001 | Terbutaline | Placebo budesonide once daily and terbutaline before exercise and as needed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| terbutaline |
| Drug |
0.4 mg as-needed |
|
|
| budesonide/formoterol | Drug | 160/4.5 yg as-needed |
|
|
| Baseline and 6 weeks |
| Concentration of Exhaled Nitric Oxide | 6 weeks |
| Use of as Needed Medication | Mean number of as needed inhalations taken before exercise | 6 weeks |
| Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5) | Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk. | Baseline e and 6 weeks |
| Diary Recording of Asthma Symptoms | Asthma symptoms during days with exercise | 6 weeks |
| Number of Participants With an Adverse Event During the Study | 6 weeks |
| Trondheim |
| Norway |
| Research Site | Gothenburg | Sweden |
| Research Site | Huddinge | Sweden |
| Research Site | Linköping | Sweden |
| Research Site | Luleå | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Skene | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Uppsala | Sweden |
| FG002 | Budesonide/Formoterol | Placebo budesonide once daily and budesonide/formoterol before exercise and as needed |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide/Terbutaline | Budesonide once daily and terbutaline before exercise and as needed |
| BG001 | Terbutaline | Placebo budesonide once daily and terbutaline before exercise and as needed |
| BG002 | Budesonide/Formoterol | Placebo budesonide once daily and budesonide/formoterol before exercise and as needed |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks | FEV1 | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Mean | Standard Deviation | Percent change | Baseline and Visit 6 |
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| |||||||||||||||||||||||||||||||
| Secondary | Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks | FEV1 | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Mean | Standard Deviation | Percent change | Baseline and 3 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Bronchial Responsiveness to Mannitol | Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15) | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Mean | Standard Deviation | mg | Baseline and 6 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Concentration of Exhaled Nitric Oxide | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Mean | Standard Deviation | ppb | 6 weeks |
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| Secondary | Use of as Needed Medication | Mean number of as needed inhalations taken before exercise | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Mean | Standard Deviation | number of inhalations per day | 6 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5) | Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk. | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Mean | Standard Deviation | units on a scale | Baseline e and 6 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Diary Recording of Asthma Symptoms | Asthma symptoms during days with exercise | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Mean | Standard Deviation | Percent of exercise days | 6 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Adverse Event During the Study | The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization. | Posted | Number | Participants | 6 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Budesonide/Terbutaline | Budesonide once daily and terbutaline before exercise and as needed | 0 | 21 | 7 | 21 | ||
| EG001 | Terbutaline | Placebo budesonide once daily and terbutaline before exercise and as needed | 0 | 22 | 10 | 22 | ||
| EG002 | Budesonide/Formoterol | Placebo budesonide once daily and budesonide/formoterol before exercise and as needed | 0 | 23 | 9 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Slight Fever | General disorders | MedDRA (10.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D013726 | Terbutaline |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D000068759 | Formoterol Fumarate |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Units |
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| Counts |
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| Participants |
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