Phase 3
Completed N=713
Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
Persistent Asthma
Source: ClinicalTrials.gov NCT02513160 ↗
Enrolled (actual)
713
Serious AEs
0.3%
Results posted
Sep 2017
Primary outcomePrimary: Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 6 Weeks (AUEC(0-6wk)) — 62; 205; 212; 210 milliliters — p=<0.0001
◆ Published Evidence
Established
25citations · ~4 / year
Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone.
Summary
The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 6 weeks (AUEC[0-6wk]).
Linked Publications (2)
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Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone.
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Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with 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 6 Weeks (AUEC(0-6wk)) |
62; 205; 212; 210 | <0.0001 sig |
| SECONDARY Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 6-Week Treatment Period |
-10.0; 20.1; 11.9; 10.9 | 0.0003 sig |
| SECONDARY Change From Baseline in Weekly Average of Daily Trough Morning Forced Expiratory Volume in One Minute (FEV1) Rate Over the 6-Week Treatment Period |
-8; 162; 135; 125 | <0.0001 sig |
| SECONDARY Change From Baseline in Weekly Average of Total Daily (24-Hour) Rescue Medication Use Over the 6-Week Treatment Period |
0.37; -0.73; -0.66; -0.66 | <0.0001 sig |
| SECONDARY Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 6-Week Treatment Period |
0.06; -0.18; -0.26; -0.24 | <0.0001 sig |
| SECONDARY Count of Participants Withdrawn From Study Drug Treatment Due to Meeting Stopping Criteria for Worsening Asthma |
10; 1; 0; 1 | 0.0058 sig |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAE) |
20; 22; 32; 32; 10; 10 | — |
Eligibility Criteria
Inclusion Criteria
- The patient has a diagnosis of asthma as defined by the NIH. The asthma diagnosis
- has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days.
- The patient has been maintained on stable doses of :
- non-corticosteroid therapy
- inhaled corticosteroid therapy
- Written informed consent/assent is obtained. For adult patients (18 years of age and older, or as applicable per local regulations), the written informed consent form (ICF) must be signed and dated by the patient before conducting any study-related procedure. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written informed assent form must be signed and dated by the patient before conducting any study-related procedure.
- The patient is a male or female 12 years of age or older as of the visit when informed consent/assent is signed (screening or prescreening visit, as applicable). (Note: Age requirements are as specified or allowed by local regulations.)
- The patient is able to perform acceptable and repeatable spirometry
- The patient is able to use an electronic diary after training.
- The patient is able to use devices properly
- If female, patient is currently not pregnant, not breast feeding, nor attempting to become pregnant (for 30 days before the screening visit (SV) and throughout the duration of the study and for 30 days after patient's last study visit) or, is of childbearing potential and not sexually active, has a negative urine pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control
- If male, the patient is willing to commit to an acceptable method of birth control for the duration of the study, is surgically sterile or exclusively has same-sex partner(s).
- The patient does not have any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator.
- The patient/parent/legal guardian is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (eg, dose schedules, visit schedules, procedures, and record keeping).
- The patient, as judged by the investigator, is able to discontinue all asthma medications at the SV.
- other criteria apply, please contact the investigator for more information
Exclusion Criteria
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures, asthma-related syncopal episode(s), or hospitalizations within the past year.
- The patient received systemic corticosteroids within 30 days before the SV (for asthma exacerbation or for other indications).
- The patient has participated in any investigational drug study as a randomized patient within the 30 days (starting at the final visit of that study) preceding SV (or prescreening visit, as applicable), or plans to participate in another investigational drug study at any time during this study.
- The patient has previously participated in a beclomethasone dipropionate breath-actuated inhaler (device) (BAI) study as a randomized patient.
- The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
- The patient has been treated with any known strong cytochrome inhibitors during the study.
- The patient has been treated with any of the prohibited medications during the prescribed (per protocol) withdrawal periods before the SV.
- The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined
Data sourced from ClinicalTrials.gov (NCT02513160) 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.