Asthma Care with Alvesco® (Ciclesonide) in Primary Care in adults - The ACCEPT-study (BY9010/CA-102)

Study identifier:BY9010/CA-102

ClinicalTrials.gov identifier:NCT00404547

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label Randomized, Multicenter Study in Patients with Asthma to Evaluate the Effectiveness of Alvesco® (Ciclesonide) Compared to Asthma Usual Care in a Primary Practice Setting

Medical condition

asthma

Phase

Phase 4

Healthy volunteers

Study drug

Ciclesonide, Usual Care Inhaled Glucocorticosteroids

Sex

All

Actual Enrollment

1121

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Nov 2006

Primary Completion Date: 01 Apr 2008

Study Completion Date: 01 Dec 2008

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

"Altana Pharma/Nycomed"

St. John's, Canada, A1A 4Z7

Location

"Altana Pharma/Nycomed"

St. John's, Canada, A1E 2C2

Location

"Altana Pharma/Nycomed"

St. John's, Canada, A1E 2E2

Location

"Altana Pharma/Nycomed"

St. John's, Canada, A1E 2X3

Location

"Altana Pharma/Nycomed"

Mount Pearl, Canada, A1N 2C1

Location

"Altana Pharma/Nycomed"

Mount Pearl, Canada, A1N 5B6

Location

"Altana Pharma/Nycomed"

Conception Bay S, Canada, A1W 3A6

Location

"Altana Pharma/Nycomed"

Shubenacadie, Canada, B0N 2H0

Arms	Assigned Interventions
Active Comparator: Alvesco Alvesco 320mcg / Alvesco 640mcg	Drug: Ciclesonide Asthma Care with Alvesco
Active Comparator: Usual Care	Drug: Usual Care Inhaled Glucocorticosteroids Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The number of subjects STARTED is related to the number of randomized subjects (= subjects who were eligible for treatment period). It differs from the number of subjects of the Intention to Treat (ITT) population in Baseline Characteristics and Outcome Measures. The statistical analyses of the Outcome Measures is based on the ITT population.

Reporting Groups

	Description
Alvesco	320 mcg/day or 640 mcg/day
Usual asthma care and dosage	as chosen by the Primary Care Physician

Participant Flow: Overall Study

	Alvesco	Usual asthma care and dosage
STARTED	762	359
COMPLETED	672	334
NOT COMPLETED	90	25
Adverse Event	39	6
Withdrawal by Subject	19	2
Protocol Violation	0	1
Lost to Follow-up	20	9
Lack of compliance	5	1
Not known	4	0
Reason not stated	3	6

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Alvesco	320 mcg/day or 640 mcg/day
Usual asthma care and dosage	as chosen by the Primary Care Physician

Baseline Measures

	Alvesco	Usual asthma care and dosage	Total
Number of Participants [units: Participants]	712	345	1057
AgeCategoricalOther ^[1] [units: years] Mean ± Standard Deviation	47.3 ± 16.3	47.2 ± 16.7	47.26 ± 16.43
GenderNIH ^[2] [units: participants]
Female	431	232	663
Male	281	113	394
Other ^[3] [units: participants]
Never	359	149	508
Current	156	81	237
Former	197	115	312
Other ^[4] [units: years] Mean ± Standard Deviation	12.4 ± 11.3	12.8 ± 11.9	12.5 ± 11.4

Outcome Measures

1. Primary Outcome Measure: Change in mean of total score of Asthma Control Questionnaire (ACQ) [ Time Frame: At the middle and end of the 12 week treatment period ]

Measure Type	Primary
Measure Name	Change in mean of total score of Asthma Control Questionnaire (ACQ)
Measure Description	The score of the change from baseline ranges from –6 (=best possible outcome) to 6 (=worst possible outcome).
Time Frame	At the middle and end of the 12 week treatment period
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Basis is the ITT population

Reporting Groups

	Description
Alvesco	320 mcg/day or 640 mcg/day
Usual asthma care and dosage	as chosen by the Primary Care Physician

Measured Values

	Alvesco	Usual asthma care and dosage
Number of Participants Analyzed [units:participants]	712	345
Change in mean of total score of Asthma Control Questionnaire (ACQ) [units: points on a scale] Mean (Standard Deviation)	-0.76 (0.97)	-0.37 (0.98)

Statistical Analysis 1 for Change in mean of total score of Asthma Control Questionnaire (ACQ)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	t-test, 2 sided
P-Value^[4]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Secondary Outcome Measure: Change in patient assessment of asthma control [ Time Frame: At baseline and at week 12 ]

Measure Type	Secondary
Measure Name	Change in patient assessment of asthma control
Measure Description	Patient assessment of asthma control was assessed at baseline and at week 12 using the question "How would you rate the control of your asthma symptoms?". The change in this assessment was categorized in "Improvement" and "Non-Improvement".
Time Frame	At baseline and at week 12
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Basis is the ITT population

Reporting Groups

	Description
Alvesco	320 mcg/day or 640 mcg/day
Usual asthma care and dosage	as chosen by the Primary Care Physician

Measured Values

	Alvesco	Usual asthma care and dosage
Number of Participants Analyzed [units:participants]	712	345
Change in patient assessment of asthma control [units: participants]
Improvement	422	132
Non-Improvement	284	209
Not reported	6	4

No statistical analysis provided for Change in patient assessment of asthma control

3. Secondary Outcome Measure: Assessment of Patient Compliance During the Study [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Name	Assessment of Patient Compliance During the Study
Measure Description
Time Frame	12 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description

Measured Values


Number of Participants Analyzed [units:participants]
Assessment of Patient Compliance During the Study [units: Participants]

No statistical analysis provided for Assessment of Patient Compliance During the Study

4. Secondary Outcome Measure: Assessment of Patient Treatment Satisfaction [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Name	Assessment of Patient Treatment Satisfaction
Measure Description
Time Frame	12 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description

Measured Values


Number of Participants Analyzed [units:participants]
Assessment of Patient Treatment Satisfaction [units: Participants]

No statistical analysis provided for Assessment of Patient Treatment Satisfaction

Serious Adverse Events

Time Frame	No text entered.
Additional Description	The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.

Reporting Groups

	Description
Alvesco	320 mcg/day or 640 mcg/day
Usual asthma care and dosage	as chosen by the Primary Care Physician