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The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.
This study is a single-dose, randomized, double-blind, placebo-controlled, 2-treatment, 2-sequence, 2-way crossover, multicenter study in patients with a documented history of EIB, with or without underlying asthma. Each patient will participate in the study for approximately 5 weeks. Each patient will complete 2 screening visits (SV1 and SV2), 2 treatment visits (TV1 and TV2), and a follow-up telephone call (FV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol Spiromax / Placebo Spiromax | Experimental | Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7. |
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| Placebo Spiromax / Albuterol Spiromax | Experimental | Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol Spiromax | Drug | Albuterol Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) containing a blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation represents a dose of 90 mcg of albuterol sulfate. Participants received one dose of two inhalations (180 mcg). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge | A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center. The percentage fall was defined as 100*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge. The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant's heart rate to ≥80% of the maximum rate for age (220 bpm-age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges. | Days 1 and 7; up to 60 minutes post-exercise challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10% | Participants were classified as protected if the maximum percentage decrease from baseline FEV1 after exercise was less than 10%. Data represents the percentage of participants who were classified as protected. | Days 1 and 7; up to 60 minutes post-exercise challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 10557 | San Diego | California | United States | |||
| Teva Investigational Site 10555 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26475054 | Derived | Ostrom NK, Taveras H, Iverson H, Pearlman DS. Novel albuterol multidose dry powder inhaler in patients with exercise-induced bronchoconstriction: A single-dose, double-blind, randomized, 2-way crossover study. Respir Med. 2015 Nov;109(11):1410-5. doi: 10.1016/j.rmed.2015.09.004. Epub 2015 Sep 8. |
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A total of 64 patients with EIB were screened. Of the 26 patients who did not participate in the study, 23 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 1 patient was withdrawn for other reason(s) before the baseline visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Albuterol Spiromax / Placebo Spiromax | Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7. |
| FG001 | Placebo Spiromax / Albuterol Spiromax |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo Spiromax | Drug | Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations. |
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| Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20% | Participants were classified as unprotected if the maximum percentage decrease from baseline FEV1 after exercise was more than 20%. Data represents the number of participants who were classified as unprotected. | Days 1 and 7; up to 60 minutes post-exercise challenge |
| Denver |
| Colorado |
| United States |
| Teva Investigational Site 10558 | Denver | Colorado | United States |
| Teva Investigational Site 10559 | Wheaton | Maryland | United States |
| Teva Investigational Site 10560 | North Dartmouth | Massachusetts | United States |
| Teva Investigational Site 10556 | Raleigh | North Carolina | United States |
Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7. |
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| NOT COMPLETED |
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Randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Albuterol Spiromax / Placebo Spiromax | Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7. |
| BG001 | Placebo Spiromax / Albuterol Spiromax | Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge | A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center. The percentage fall was defined as 100*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge. The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant's heart rate to ≥80% of the maximum rate for age (220 bpm-age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges. | Full analysis set | Posted | Mean | Standard Error | percentage change from baseline FEV1 | Days 1 and 7; up to 60 minutes post-exercise challenge |
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| Secondary | Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10% | Participants were classified as protected if the maximum percentage decrease from baseline FEV1 after exercise was less than 10%. Data represents the percentage of participants who were classified as protected. | Full analysis set | Posted | Number | percentage of participants | Days 1 and 7; up to 60 minutes post-exercise challenge |
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| Secondary | Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20% | Participants were classified as unprotected if the maximum percentage decrease from baseline FEV1 after exercise was more than 20%. Data represents the number of participants who were classified as unprotected. | Full analysis set | Posted | Number | participants | Days 1 and 7; up to 60 minutes post-exercise challenge |
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Days 1-14
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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 | Albuterol Spiromax 180 mcg | Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation) | 0 | 38 | 0 | 38 | ||
| EG001 | Placebo Spiromax | Single dose of Placebo Spiromax (2 inhalations) | 0 | 38 | 0 | 38 |
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Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teva Branded Pharmaceutical Products, R&D Inc. | Director, Clinical Research | 1-215-591-3000 | ustevatrials@tevapharm.com |
| >=18 years |
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| Black |
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| Asian |
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| Other |
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| Non-Hispanic and non-Latino |
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