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This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol 18.75 µg | Experimental | Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
|
| Indacaterol 37.5 µg | Experimental | Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
|
| Indacaterol 75 µg | Experimental | Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
|
| Indacaterol 150 µg | Experimental | Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol | Drug | Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment | Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates. | Day 15 (after 2 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment | Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates. |
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Inclusion Criteria:
Patients with a diagnosis of asthma, and:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Glendale | Arizona | 85306 | United States | ||
| Novartis Investigator Site |
The study consisted of a 14 day run-in period. 511 participants were randomized but only 502 participants received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol 18.75 µg | Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Salmeterol | Active Comparator | Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
|
| Placebo | Placebo Comparator | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
|
| Salmeterol | Drug | 50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. |
|
| Placebo to Indacaterol | Drug | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI. |
|
| Placebo to Salmeterol | Drug | Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI). |
|
| Day 2 (after 1 day of treatment) |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Novartis Investigator Site | Encinitas | California | 92024 | United States |
| Novartis Investigator Site | Huntington Beach | California | 92647 | United States |
| Novartis Investigator Site | Los Angeles | California | 90025 | United States |
| Novartis Investigator Site | Los Angeles | California | 90048 | United States |
| Novartis Investigative Site | Mission Viejo | California | 92691 | United States |
| Novartis Investigator Site | Orange | California | 92868 | United States |
| Novartis Investigator Site | Rancho Mirage | California | 92270 | United States |
| Novartis Investigator Site | Rolling Hills Estates | California | 90274 | United States |
| Novartis Investigator Site | San Diego | California | 92120 | United States |
| Novartis Investigator Site | San Diego | California | 92123 | United States |
| Novartis Investigator Site | San Jose | California | 95117 | United States |
| Novartis Investigator Site | Stockton | California | 95207 | United States |
| Novartis Investigator Site | Colorado Springs | Colorado | 80907 | United States |
| Novartis Investigator Site | Denver | Colorado | 80230 | United States |
| Novartis Investigator Site | Engelwood | Colorado | 80112 | United States |
| Novartis Investigator Site | Lakewood | Colorado | 80401 | United States |
| Novartis Investigative Site | Stamford | Connecticut | 06902 | United States |
| Novartis Investigative Site | Waterbury | Connecticut | 06708 | United States |
| Novartis Investigative site | Destin | Florida | 32541 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32503 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32514 | United States |
| Novartis Investigative Site | Port Orange | Florida | 32127 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34233 | United States |
| Novartis Investigative Site | Tamarac | Florida | 33321 | United States |
| Novartis Investigative Site | Winter Park | Florida | 32789 | United States |
| Novartis Investigator Site | Boise | Idaho | 83704 | United States |
| Novartis Investigator Site | Normal | Illinois | 61761 | United States |
| Novartis Investigative Site | Springfield | Illinois | 62703 | United States |
| Novartis Investigator Site | Overland Park | Kansas | 66210 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40215 | United States |
| Novartis Investigator Site | Lafayette | Louisiana | 70503 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21236 | United States |
| Novartis Investigator Site | Columbia | Maryland | 21044 | United States |
| Novartis Investigative Site | Wheaton | Maryland | 20902 | United States |
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Novartis Investigator Site | Columbia | Missouri | 65203 | United States |
| Novartis Investigator Site | Rolla | Missouri | 65401 | United States |
| Novartis Investigator Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigator Site | Warrensburg | Missouri | 64093 | United States |
| Novartis Investigative Site | Missoula | Montana | 59808 | United States |
| Novartis Investigator Site | Bellevue | Nebraska | 68123 | United States |
| Novartis Investigator Site | Boys Town | Nebraska | 68010 | United States |
| Novartis Investigative Site | Ocean City | New Jersey | 07712 | United States |
| Novartis Investigative Site | Skillman | New Jersey | 08558 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Novartis Investigator Site | Cadiz | Ohio | 43907 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43215 | United States |
| Novartis Investigative Site | Maumee | Ohio | 43537 | United States |
| Novartis Investigator Site | Oklahoma City | Oklahoma | 73103 | United States |
| Novartis Investigator Site | Lake Oswego | Oregon | 97035 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novartis Investigator Site | Portland | Oregon | 97213 | United States |
| Novartis Investigative Site | Erie | Pennsylvania | 16506 | United States |
| Novartis Investigative Site | Phoenixville | Pennsylvania | 19460 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Novartis Investigative Site | Upland | Pennsylvania | 19013 | United States |
| Novartis Investigative Site | Lincoln | Rhode Island | 02865 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29414 | United States |
| Novartis Investigative site | North Charleston | South Carolina | 29406 | United States |
| Novartis Investigator Site | Austin | Texas | 78758 | United States |
| Novartis Investigator Site | Dallas | Texas | 75231 | United States |
| Novartis Investigator Site | El Paso | Texas | 79903 | United States |
| Novartis Investigator Site | El Paso | Texas | 79925 | United States |
| Novartis Investigator Site | Georgetown | Texas | 78628 | United States |
| Novartis Investigator Site | North Richland Hills | Texas | 76180 | United States |
| Novartis Investigator Site | Waco | Texas | 73712 | United States |
| Novartis Investigator Site | Seattle | Washington | 98105 | United States |
| FG001 | Indacaterol 37.5 µg | Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| FG002 | Indacaterol 75 µg | Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| FG003 | Indacaterol 150 µg | Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| FG004 | Salmeterol | Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| FG005 | Placebo | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| Safety Set: Received Study Drug |
|
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol 18.75 µg | Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study |
| BG001 | Indacaterol 37.5 µg | Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| BG002 | Indacaterol 75 µg | Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| BG003 | Indacaterol 150 µg | Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| BG004 | Salmeterol | Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| BG005 | Placebo | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| BG006 | 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 Continuous | All baseline measures are based on the Full Analysis Set (FAS) that includes all participants who received at least one dose of study drug. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment | Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates. | Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | Liters | Day 15 (after 2 weeks of treatment) |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment | Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates. | Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. | Posted | Least Squares Mean | Standard Error | Liters | Day 2 (after 1 day of treatment) |
|
2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indacaterol 18.75 µg | Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study | 0 | 84 | 4 | 84 | ||
| EG001 | Indacaterol 37.5 µg | Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | 0 | 81 | 2 | 81 | ||
| EG002 | Indacaterol 75 µg | Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | 0 | 84 | 12 | 84 | ||
| EG003 | Indacaterol 150 µg | Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | 1 | 85 | 7 | 85 | ||
| EG004 | Salmeterol | Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | 0 | 84 | 5 | 84 | ||
| EG005 | Placebo | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | 0 | 84 | 4 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Substance abuse | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C510790 | indacaterol |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|
| OG002 | Indacaterol 75 µg | Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| OG003 | Indacaterol 150 µg | Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| OG004 | Salmeterol | Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
| OG005 | Placebo | Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. |
|
|