Exercise-Induced Bronchoconstriction (EIB)Phase 3NCT01791972
Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
A Phase 3 study testing Albuterol Spiromax in people with Exercise-Induced Bronchoconstriction (EIB), run by Teva Branded Pharmaceutical Products R&D, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Exercise-Induced Bronchoconstriction (EIB)
- What is being tested?
- Albuterol Spiromax
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2013to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent/assent: For patients 18 to 50 years of age, inclusive, written informed consent signed and dated by the patient before conducting any study related procedures and review of Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization; for patients 12 to 17 years of age, inclusive, written informed consent signed and dated by the parent/legal guardian and written assent signed and dated by the patient before conducting any study related procedure and review of HIPAA authorization.
- Male or female patients 12 to 50 years of age, inclusive, as of SV1.
- If female, is currently not pregnant, breastfeeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of non-childbearing potential.
- Documented history of EIB, with or without underlying asthma. The underlying asthma must be well-controlled (in the investigator's judgment) as per the National Asthma Education and Prevention Program, Expert Panel Report (NAEPP, EPR-3).
- Other criteria apply.
Who cannot join
- Requires a rescue bronchodilator following the exercise challenge at SV1 for a decrease in FEV1 that does not return to within 20% of their pre-exercise challenge FEV1 within 30 minutes after administration of the rescue medication.
- Pregnant, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days after the patient's last study related visit (for eligible patients only-if applicable).
- Participation in any investigational drug trial within the 30 days preceding SV1 or planned participation in another investigational drug trial at any time during this trial.
- A known hypersensitivity to albuterol or any of the excipients in the formulation.
- History of severe milk protein allergy.
- History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, otitis media, acute or chronic sinusitis, influenza, etc) that has not resolved within the 2 weeks preceding SV1.
- Other criteria apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Teva Investigational Site 10555
Denver, Colorado
Teva Investigational Site 10558
Denver, Colorado
Teva Investigational Site 10560
North Dartmouth, Massachusetts
Teva Investigational Site 10556
Raleigh, North Carolina
Teva Investigational Site 10557
San Diego, California
Teva Investigational Site 10559
Wheaton, Maryland
About this study
Official title: A Single-Dose Study to Assess the Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
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.
Read the detailed description
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).
- Being tested
- Albuterol Spiromax, Placebo Spiromax
- Keywords
- Exercise-Induced Bronchoconstriction (EIB), Spiromax®, Albuterol sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol SpiromaxDrug
Also called Albuterol DPI, ProAir® RespiClick
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).
Placebo SpiromaxDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Albuterol Spiromax; Drug: Placebo Spiromax |
| 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. Receives: Drug: Albuterol Spiromax; Drug: Placebo Spiromax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1 and 7; up to 60 minutes post-exercise challenge
Secondary outcomes (2)
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.
Measured: Days 1 and 7; up to 60 minutes post-exercise challenge
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.
Measured: Days 1 and 7; up to 60 minutes post-exercise challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise-Induced Bronchoconstriction (EIB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791972
- Sponsor's protocol ID
- ABS-AS-302
- Status last verified
- May 2015
- First submitted
- 12 Feb 2013
- Last updated
- 18 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26475054
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Study to Assess the Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
- ClinicalTrials.gov ID
- NCT01791972
- Acronym / sponsor ID
- ABS-AS-302
- Keywords
- Exercise-Induced Bronchoconstriction (EIB), Spiromax®, Albuterol sulfate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Posted 19 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albuterol Spiromax / Placebo Spiromax | Experimental | Drug: Albuterol Spiromax, Drug: Placebo SpiromaxAlbuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7. |
| Placebo Spiromax / Albuterol Spiromax | Experimental | Drug: Albuterol Spiromax, Drug: Placebo SpiromaxPlacebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent/assent: For patients 18 to 50 years of age, inclusive, written informed consent signed and dated by the patient before conducting any study related procedures and review of Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization; for patients 12 to 17 years of age, inclusive, written informed consent signed and dated by the parent/legal guardian and written assent signed and dated by the patient before conducting any study related procedure and review of HIPAA authorization.
- Male or female patients 12 to 50 years of age, inclusive, as of SV1.
- If female, is currently not pregnant, breastfeeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of non-childbearing potential.
- Documented history of EIB, with or without underlying asthma. The underlying asthma must be well-controlled (in the investigator's judgment) as per the National Asthma Education and Prevention Program, Expert Panel Report (NAEPP, EPR-3).
- Other criteria apply.
Key exclusion criteria (7 listed)
- Requires a rescue bronchodilator following the exercise challenge at SV1 for a decrease in FEV1 that does not return to within 20% of their pre-exercise challenge FEV1 within 30 minutes after administration of the rescue medication.
- Pregnant, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days after the patient's last study related visit (for eligible patients only-if applicable).
- Participation in any investigational drug trial within the 30 days preceding SV1 or planned participation in another investigational drug trial at any time during this trial.
- A known hypersensitivity to albuterol or any of the excipients in the formulation.
- History of severe milk protein allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol SpiromaxAlso: Albuterol DPI, ProAir® RespiClickAlbuterol 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). | Drug | Albuterol Spiromax / Placebo Spiromax, Placebo Spiromax / Albuterol Spiromax |
| Placebo SpiromaxPlacebo 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. | Drug | Albuterol Spiromax / Placebo Spiromax, Placebo Spiromax / Albuterol Spiromax |
Primary outcome
Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge
Time frame: Days 1 and 7; up to 60 minutes post-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.
2 secondary outcomes
Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%
Time frame: Days 1 and 7; up to 60 minutes post-exercise challenge
Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%
Time frame: Days 1 and 7; up to 60 minutes post-exercise challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26475054Ostrom 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albuterol Spiromax in people with Exercise-Induced Bronchoconstriction (EIB), run by Teva Branded Pharmaceutical Products R&D, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge (time frame: Days 1 and 7; up to 60 minutes post-exercise challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01791972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.