Trial · NCT02031640
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
NCT02031640, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2018-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma. Trials, record NCT02031640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02031640
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
- NCT number
- NCT02031640
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,113 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Asthma
- Interventions
- Beclomethasone dipropionate, Placebo, Albuterol/salbutamol
- First posted
- 2014-01-09
- Last updated
- 2021-11-09
- Other registries' IDs
- eudract:2013-003397-27
- Results first posted
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) | Day 1 (baseline), Weeks 2, 4, 8, 12 | Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used. Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule. The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t \<12 weeks (2, 4, or 8 weeks). |
| Secondary | Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12 | A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. Daily trough morning PEF assessments were taken pre-dose and pre-rescue bronchodilator over the 12-week treatment period. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary. Baseline in trough morning PEF is defined as the average of recorded trough morning PEF assessments over the 7-day window before randomization, including the morning assessment on Day 1 before randomization. Weekly average PEF data was generated using 7-day windows based on analysis days (before the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time by treatment interaction. |
| Secondary | Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12 | A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary. Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization. Weekly average PEF data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening peak PEF, sex, age, treatment, time, and time by treatment interaction. |
| Secondary | Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM) | Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12 | Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including the morning usage at the randomization visit. Weekly average rescue medication data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). Weekly average over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline value, sex, age, time, treatment, and time-by-treatment interaction. |
| Secondary | Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM) | Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12 | Asthma symptom scores are recorded in the patient's diary each morning and each evening before determining PEF and before administration of study or rescue medications. The Daytime Symptom Score (determined in the evening) has a range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. The Nighttime Symptom Score (determined in the morning) has a range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score is the average of the daytime and the nighttime scores (full scale is 0 - 4.5). The total daily asthma symptom score is missing if either the daytime or nighttime score is missing. Baseline was the average of recorded daily asthma symptom scores over 7 days prior to the first dose of study treatment. The weekly average was the sum of total daily asthma symptom scores over the 7 days divided by the number of non-missing assessments. |
| Secondary | Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma | Day 1 - Week 12 | Time to withdrawal due to meeting stopping criteria is defined as number of days elapsed from the date of the first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Stopping criteria are: * FEV1 as measured at the study center is below the FEV1 stability limit value calculated at RV. * Based upon review of patient diary data, the patient has experienced any of the following during any 7-day period: * 4+ days in which the highest (of 3 efforts) am PEF fall below the PEF stability limit calculated when randomized. The patient meets with the investigator who determines whether the FEV1 is consistent with worsening asthma; * 3+ days in which 12+ inhalations/day of rescue medication were used * 2+ days in which the patient experienced a nighttime asthma symptom score of more than 2 * Clinical asthma exacerbation requiring (for example) the use of systemic corticosteroids, or the emergency room or hospitalization. |
| Secondary | Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period | Treatment period: Day 1 up to Week 12 | A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of alert criteria is: * FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1). * Other criteria as defined in the protocol. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) | Day 1 (baseline), Weeks 2, 4, 8, 12 | Full analysis set- randomized patients with at least 1 dose of drug and 1 postbaseline trough am FEV1 | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12 | Full Analysis Set | Liters/minute | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12 | Full Analysis Set | Liters/minute | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM) | Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12 | Full analysis set | number of inhalations | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM) | Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12 | Full analysis set. Analysis used a MMRM with effects due to baseline score, sex, age, time, treatment, and time-by-treatment interaction. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma | Day 1 - Week 12 | Full analysis set; unable to calculate as few patients met stopping criteria | days | MEDIAN |
| SECONDARY | Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period | Treatment period: Day 1 up to Week 12 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) | Placebo BAI and MDI | 0.056 | Standard Error 0.0219 | Liters | |
| Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) | BDP 320 mcg BAI | 0.09 | Standard Error 0.0221 | Liters | |
| Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) | BDP 640 mcg BAI | 0.101 | Standard Error 0.0221 | Liters | |
| Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) | BDP 320 mcg MDI | 0.041 | Standard Error 0.0217 | Liters | |
| Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) | BDP 640 mcg MDI | 0.096 | Standard Error 0.0216 | Liters | |
| Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | Placebo BAI and MDI | -5.524 | Standard Error 2.5944 | Liters/minute | |
| Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | BDP 320 mcg BAI | 5.092 | Standard Error 2.5625 | Liters/minute | |
| Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | BDP 640 mcg BAI | 2.895 | Standard Error 2.559 | Liters/minute | |
| Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | BDP 320 mcg MDI | 0.480 | Standard Error 2.558 | Liters/minute | |
| Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM) | BDP 640 mcg MDI | 6.988 | Standard Error 2.5298 | Liters/minute |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening Period | STARTED | Consented Patients - Standard ICS and Placebo | 1,113 | |
| Screening Period | STARTED | Placebo BAI and MDI | 0 | |
| Screening Period | STARTED | BDP 320 mcg BAI | 0 | |
| Screening Period | STARTED | BDP 640 mcg BAI | 0 | |
| Screening Period | STARTED | BDP 320 mcg MDI | 0 | |
| Screening Period | STARTED | BDP 640 mcg MDI | 0 | |
| Screening Period | COMPLETED | Consented Patients - Standard ICS and Placebo | 701 | |
| Screening Period | COMPLETED | Placebo BAI and MDI | 0 | |
| Screening Period | COMPLETED | BDP 320 mcg BAI | 0 | |
| Screening Period | COMPLETED | BDP 640 mcg BAI | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oral candidiasis | Infections and infestations | BDP 320 mcg BAI | 5 | 106 | 7 |
| other | Oral candidiasis | Infections and infestations | BAI 640 mcg/Day | 10 | 106 | 12 |
| other | Oral candidiasis | Infections and infestations | MDI 320 mcg/Day | 3 | 107 | 3 |
| other | Oral candidiasis | Infections and infestations | MDI 640 mcg/Day | 9 | 107 | 11 |
| other | Oral candidiasis | Infections and infestations | Placebo BAI and MDI | 0 | 106 | 0 |
| other | Oral candidiasis | Infections and infestations | Run-in Period Experience for Randomized Participants | 7 | 532 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | BDP 320 mcg BAI | 4 | 106 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | BAI 640 mcg/Day | 1 | 106 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | MDI 320 mcg/Day | 7 | 107 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | MDI 640 mcg/Day | 4 | 107 | 4 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BDP 320 mcg BAI | 0 | 106 |
| Total, all-cause mortality | BAI 640 mcg/Day | 0 | 106 |
| Total, all-cause mortality | MDI 320 mcg/Day | 0 | 107 |
| Total, all-cause mortality | MDI 640 mcg/Day | 0 | 107 |
| Total, all-cause mortality | Placebo BAI and MDI | 0 | 106 |
| Total, all-cause mortality | Run-in Period Experience for Randomized Participants | 0 | 532 |
| Total, other adverse events | BDP 320 mcg BAI | 9 | 106 |
| Total, other adverse events | BAI 640 mcg/Day | 11 | 106 |
| Total, other adverse events | MDI 320 mcg/Day | 9 | 107 |
| Total, other adverse events | MDI 640 mcg/Day | 12 | 107 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27510595 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02031640
GET https://conductscience.org/api/trials/v1/NCT02031640/results?page=2