N/A Completed N=516 Randomized Treatment

Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices

Asthma

Source: ClinicalTrials.gov NCT02570425 ↗

Enrolled (actual)

516

Serious AEs

—

Results posted

May 2016

Primary outcomePrimary: Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor — 40; 64 percent of participants

Summary

This study is conducted to assess the ease of device mastery of a placebo SYMBICORT TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals in-training (HCP).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor	40; 64	—
SECONDARY Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor	4; 22	—
SECONDARY Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor	31; 58	—
SECONDARY Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor	40; 64	—
SECONDARY Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor	77; 86	—
SECONDARY Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor	65; 79	—
SECONDARY Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor	93; 92	—
SECONDARY Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor	20; 113; 142; 186; 176; 87	—
SECONDARY Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor	202; 317; 182; 113; 60; 34	—
SECONDARY Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor	299; 362; 127; 63; 16; 20	—
SECONDARY The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor	2.48; 3.03; 1.57; 1.94; 1.33; 1.45	—
SECONDARY Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants	2540; 1447	—
SECONDARY Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants	780; 367	—
SECONDARY Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants	296; 175	—
SECONDARY Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants	62; 0; 318; 0; 0; 614	—
SECONDARY Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants	6; 0; 106; 0; 0; 184	—
SECONDARY Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants	3; 0; 34; 0; 0; 70	—
SECONDARY Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score	74; 16; 10	—
SECONDARY Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score	74.5; 15.5; 10	—
SECONDARY Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score	79; 14; 7	—

Eligibility Criteria

Inclusion Criteria

Written informed consent is obtained and dated by the participant before conducting any study related procedures.
The participant is a student that is currently enrolled in the University where the study is conducted
The participant must be willing and able to comply with study restrictions and to remain at the study site for the required duration during the study period, and willing to return to the site for the follow up evaluation as specified in this protocol.
The participant has not previously used or received training in the use of either the SPIROMAX or the TURBOHALER in the last 6 months

Exclusion Criteria

Participants will be excluded from participating in this study if they have asthma.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02570425). 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.