Phase 3
Completed N=273
A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma
Persistent Asthma
Source: ClinicalTrials.gov NCT02040779 ↗
Enrolled (actual)
273
Serious AEs
0.4%
Results posted
Dec 2017
Primary outcomePrimary: Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received — 0.048; 0.171; 0.164 liters — p=0.0010
◆ Published Evidence
Emerging
3citations · ~0 / year
Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered <i>via</i> a breath-actuated inhaler for persistent asthma.
Summary
This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study
Linked Publications
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Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered <i>via</i> a breath-actuated inhaler for persistent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received |
0.048; 0.171; 0.164 | 0.0010 sig |
| SECONDARY Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period |
-0.795; 12.849; 7.116 | 0.0443 sig |
| SECONDARY Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period |
-0.797; 10.105; 4.608 | 0.2014 |
| SECONDARY Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12 |
-0.010; -0.368; -0.398 | 0.0175 sig |
| SECONDARY Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period |
-0.166; -0.293; -0.304 | 0.0335 sig |
| SECONDARY Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period |
NA; NA; NA | — |
| SECONDARY Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period |
5; 2; 0 | 0.2384 |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAEs) |
28; 32; 26; 2; 0; 0 | — |
| SECONDARY Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period |
2; 2; 2; 1; 1; 1 | — |
| SECONDARY Participants With Findings During Oropharyngeal Examination During Treatment |
0; 0; 2; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999).
- Current asthma therapy: The patient is currently being treated with 1 of the following:
- inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
- Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information
Exclusion Criteria
- The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
- The patient is a pregnant or lactating female or plans to become pregnant.
- The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
- The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year.
- The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
- The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
- Other criteria apply, please contact the investigator for more information
Data sourced from ClinicalTrials.gov (NCT02040779) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.