Clinical Trial Results:
A Study to Measure Serum Periostin, Asthma-Related Biomarkers and Response to Prednisolone in Adult and Adolescent Patients With Severe Oral Corticosteroid-Dependent Asthma
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Summary
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EudraCT number |
2013-000900-41 |
Trial protocol |
GB |
Global end of trial date |
28 Apr 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Apr 2016
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First version publication date |
21 Apr 2016
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Other versions |
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Summary report(s) |
Supporting document for 1 participant with missing age |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
WB28850
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01948401 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche, Ltd
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, 4070
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Public contact |
Regulatory Affairs, Roche Trial Information Hotline, +41 61 6878333, global.trial_information@roche.com
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Scientific contact |
Regulatory Affairs, Roche Trial Information Hotline, +41 61 6878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Mar 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Apr 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Apr 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the levels of serum periostin in a population of patients with severe oral corticosteroid (OCS) dependent asthma at Baseline
To examine the stability of serum periostin levels and individual patient phenotypes in relation to sputum eosinophils (as defined by % eosinophils), blood eosinophil count, fractional exhaled nitric oxide (FeNO [parts-per-billion]), lung function (forced expiratory volume in 1 second [FEV1]), and Asthma Control Questionnaire (ACQ-7)
To examine the changes in serum periostin levels in a study population with uncontrolled asthma that receives 7 days of high-dose OCS treatment and relate these changes to blood eosinophils, FeNO, lung function, Asthma Quality of Life Questionnaire for adults and adolescents age 12 years and older [AQLQ12+], and ACQ-7
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all participants and/or their legally authorized representative. Participants signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2013
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
3 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 54
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Worldwide total number of subjects |
54
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EEA total number of subjects |
54
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
47
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
Overall 54 participants were randomized. Of these, 42 participated in the follow-up phase and 40 participants completed the study. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
Approximately 130 participants were planned at study centers in the UK. However, the study was terminated early due to slow recruitment. Sites were planned to participate in Study WB28182 and participation in Study WB28850 ended when Study WB28182 was ready to begin enrolment. Therefore, the final number of participants enrolled was 54. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Controlled Asthma | ||||||||||||||||||||
Arm description |
Participants with controlled asthma were included in this arm. Participants not meeting the “uncontrolled” asthma criteria listed were defined as “controlled”. “Uncontrolled” asthma criteria were: Asthma Control Questionnaire (ACQ)-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/milliliter [mL]) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Uncontrolled Asthma with OCS | ||||||||||||||||||||
Arm description |
Participants with uncontrolled asthma who consented to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Prednisolone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants with uncontrolled asthma were administered prednisolone tablets 0.5 mg/kg (to the nearest 5 mg) be taken daily for 7 days in addition to their maintenance OCS.
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Arm title
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Uncontrolled Asthma with No OCS | ||||||||||||||||||||
Arm description |
Participants with uncontrolled asthma who did not consent to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Controlled Asthma
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Reporting group description |
Participants with controlled asthma were included in this arm. Participants not meeting the “uncontrolled” asthma criteria listed were defined as “controlled”. “Uncontrolled” asthma criteria were: Asthma Control Questionnaire (ACQ)-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/milliliter [mL]) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Uncontrolled Asthma with OCS
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Reporting group description |
Participants with uncontrolled asthma who consented to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Uncontrolled Asthma with No OCS
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Reporting group description |
Participants with uncontrolled asthma who did not consent to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Controlled Asthma
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Reporting group description |
Participants with controlled asthma were included in this arm. Participants not meeting the “uncontrolled” asthma criteria listed were defined as “controlled”. “Uncontrolled” asthma criteria were: Asthma Control Questionnaire (ACQ)-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/milliliter [mL]) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||
Reporting group title |
Uncontrolled Asthma with OCS
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Reporting group description |
Participants with uncontrolled asthma who consented to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||
Reporting group title |
Uncontrolled Asthma with No OCS
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Reporting group description |
Participants with uncontrolled asthma who did not consent to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||
Subject analysis set title |
Full-analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The full-analysis set (FAS) was used in all analyses and consisted of all participants who met the criteria for entering the study.
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End point title |
Change from Baseline in serum periostin levels at Visits 2, 3, 4 and 5 [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change from Baseline values were measured by participant group and by serum periostin level, where Baseline was Day 0 (Visit 1) or last non-missing measurement of screening. Baseline periostin <50 ng/mL was classed as low (PL) and Baseline serum periostin >=50 ng/mL was classed as high (PH). Change from Baseline: Post baseline value — Baseline value. The full-analysis set (FAS) was used for analysis and consisted of all participants who met the criteria for entering the study. Participants only with a value at Baseline and post-baseline are analysed and are represented by n=X, X, X. Parameters for which values are not calculated are presented as zero (0).
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End point type |
Primary
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End point timeframe |
From Baseline (Day 0) to Visit 2 (Day 8), Visit 3 (Day 39), Visit 4 (Day 67) and Visit 5 (Day 95)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in serum periostin in relation to blood eosinophil count at Visits 2, 3, 4 and 5 [2] | ||||||||||||||||||||||||||||||||
End point description |
Change from baseline values were measured in serum periostin in relation to blood eosinophil count, where baseline was Day 0 (Visit 1) or last non-missing measurement of screening. Change from Baseline: Post baseline value — Baseline value. The FAS was used for analysis. Participants only with a value at Baseline and post-baseline are analysed and are represented by n=X, X, X. Parameters for which values are not calculated are presented as zero (0). A line plot of serum periostin versus blood eosinophil counts by low baseline serum periostin level and high baseline serum periostin level is provided in Figure 2 (as attachment). The figure illustrates that both blood eosinophil counts and serum periostin decrease in a response to additional OCS but then return to baseline levels, the effect being more pronounced in the group with high baseline serum periostin.
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End point type |
Primary
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End point timeframe |
From Baseline (Day 0) to Visit 2 (Day 8), Visit 3 (Day 39), Visit 4 (Day 67) and Visit 5 (Day 95)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses was performed. |
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Attachments |
Serum Periostin in relation Blood Eosinophils |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in serum periostin in relation to Fractional Exhaled Nitric Oxide at Visits 2, 3, 4 and 5 [3] | ||||||||||||||||||||||||||||||||
End point description |
Change from Baseline values were measured in serum periostin in relation to FeNO, where Baseline is Day 0 (Visit 1) or last non-missing measurement of screening. Change from Baseline: Post baseline value — Baseline value. FeNO is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to other ways of assessing airways disease, including asthma. The FAS was used for analysis. Participants only with a value at Baseline and post-baseline are analysed and are represented by n=X, X, X. Parameters for which values are not calculated are presented as zero (0). A line plot of serum periostin versus FeNO by low baseline serum periostin level and high baseline serum periostin level is provided in Figure 4 (as attachment). The figure illustrates that both FeNO and serum periostin decrease in a response to additional OCS, the effect being more pronounced in the group with high baseline serum periostin.
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End point type |
Primary
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End point timeframe |
From Baseline (Day 0) to Visit 2 (Day 8), Visit 3 (Day 39), Visit 4 (Day 67) and Visit 5 (Day 95)
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses was performed. |
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Attachments |
Serum Periostin in Relation to FeNO |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in serum periostin in relation to Asthma Control Questionnaire-7 score at Visits 2, 3, 4 and 5 [4] | ||||||||||||||||||||||||||||||||
End point description |
Change from Baseline (BL) was measured in serum periostin (SP) in relation to ACQ-7 score. It describes questions related to frequency and severity of asthma. Participants recall about their asthma during the previous week and have to respond to questions about symptoms and bronchodilator use on a 7-point scale (where 0=no impairment, 6=maximum impairment). The ACQ score is the mean of the 7 questions; scores lie between 0 (totally controlled) and 6 (severely uncontrolled). The FAS was used for analysis. Participants only with a value at BL and Post-BL are analysed (presented as n=X, X, X). Change from BL (BL: Day 0 or last non-missing value): Post BL value —BL value. Not calculated parameters are presented as 0. A line plot of SP in relation to ACQ-7 is presented in Figure 6, which illustrates that both ACQ-7 score and SP decrease in a response to additional OCS but then return to BL levels, the effect being more pronounced in the group with high baseline serum periostin levels.
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End point type |
Primary
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End point timeframe |
From Baseline (Day 0) to Visit 2 (Day 8), Visit 3 (Day 39), Visit 4 (Day 67) and Visit 5 (Day 95)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses was performed. |
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Attachments |
Serum Periostin in Relation to ACQ-7 |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in serum periostin in relation to Asthma Quality of Life Questionnaire 12+ at Visits 2, 3, 4 and 5 [5] | ||||||||||||||||||||||||||||||||
End point description |
Change from Baseline (BL) was measured in serum periostin (SP) in relation to AQLQ12+ score by participant group. The questionnaire contains 4 domains: activity limitations, symptoms, emotional function, and environmental stimuli. The AQLQ12+ is based on a 2-week recall period and consists of 32 questions, each scored from 1 (Worse) to 7 (Better). An increase in the AQLQ score indicates a better quality of life. The FAS was used for analysis. Participants only with a value at BL and Post-BL are analysed (presented as n=X, X, X). Change from BL (BL: Day 0 or last non-missing value): Post BL value —BL value. Not calculated parameters are presented as 0. A line plot of SP in relation to AQLQ12+ is presented in Figure 8. The figure illustrates a small increase between BL and subsequent visits for AQLQ12+ score. However, overall the AQLQ12+ scores remain stable and do not appear to be meaningfully impacted by the increase in OCS. A similar pattern was observed between the BL SP levels.
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End point type |
Primary
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End point timeframe |
From Baseline (Day 0) to Visit 2 (Day 8), Visit 3 (Day 39), Visit 4 (Day 67) and Visit 5 (Day 95)
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses was performed. |
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Attachments |
Serum Periostin in Relation to AQLQ12+ |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Change from Baseline in serum periostin in relation to FEV1 at Visits 2, 3, 4 and 5 [6] | ||||||||||||||||||||||||||||||||
End point description |
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Change from baseline value in serum periostin in relation to pre-bronchodilator FEV1 was measured, where baseline was Day 0 (Visit 1) or last non-missing measurement prior to dosing. Change from Baseline: Post baseline value — Baseline value. The FAS was used for analysis. Participants only with a value at Baseline and post-baseline are analysed and are represented by n=X, X, X. Parameters for which values are not calculated are presented as zero (0). A line plot of serum periostin versus FEV1 by low baseline serum periostin level and high baseline serum periostin level is provided in Figure 10 (as attachment). The figure illustrates that FEV1 levels show an increase with an increase in OCS, the effect being more pronounced in the group with high baseline serum periostin levels.
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End point type |
Primary
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End point timeframe |
From Baseline (Day 0) to Visit 2 (Day 8), Visit 3 (Day 39), Visit 4 (Day 67) and Visit 5 (Day 95)
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses was performed. |
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Attachments |
Serum Periostin in Relation to FEV1 |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Approximately up to 95 days
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Adverse event reporting additional description |
Serious adverse events and non-serious adverse events are reported in Full Analysis Set, which consists of all participants who met the criteria for entering the study.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
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Reporting groups
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Reporting group title |
Controlled Asthma
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Reporting group description |
Participants with controlled asthma were included in this arm. Participants not meeting the “uncontrolled” asthma criteria listed were defined as “controlled”. “Uncontrolled” asthma criteria: Asthma Control Questionnaire (ACQ)-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Uncontrolled Asthma with OCS
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Reporting group description |
Participants with uncontrolled asthma who consented to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Uncontrolled Asthma with No OCS
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Reporting group description |
Participants with uncontrolled asthma who did not consent to additional use of oral corticosteroid were included in this arm. “Uncontrolled” asthma criteria: ACQ-7 >1.25 or persistent blood eosinophil count (>0.4 X 10^9/mL) or persistent sputum eosinophilia (>3%) or recurrent exacerbations requiring a boost in steroid dose | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Feb 2013 |
After seeking advice from Medicines and Healthcare products Regulatory Agency (MHRA), the trial was classified as interventional due to the use of Prednisolone as an investigational product. The protocol was amended and the word 'non-investigational' was replaced by 'investigational'. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
