Trial Outcomes & Findings for Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102) (NCT NCT00404547)

Results Overview

The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1121 participants

Primary outcome timeframe

At the middle and end of the 12 week treatment period

Results posted on

2017-02-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Alvesco 320 mcg/day or 640 mcg/day	Usual Asthma Care and Dosage as chosen by the Primary Care Physician
Overall Study STARTED	762	359
Overall Study COMPLETED	672	334
Overall Study NOT COMPLETED	90	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Alvesco 320 mcg/day or 640 mcg/day	Usual Asthma Care and Dosage as chosen by the Primary Care Physician
Overall Study Adverse Event	39	6
Overall Study Withdrawal by Subject	19	2
Overall Study Protocol Violation	0	1
Overall Study Lost to Follow-up	20	9
Overall Study Lack of compliance	5	1
Overall Study Other	4	0
Overall Study Reason not stated	3	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alvesco n=712 Participants 320 mcg/day or 640 mcg/day	Usual Asthma Care and Dosage n=345 Participants as chosen by the Primary Care Physician	Total n=1057 Participants Total of all reporting groups
Age, Customized	47.3 years STANDARD_DEVIATION 16.3 • n=99 Participants	47.2 years STANDARD_DEVIATION 16.7 • n=107 Participants	47.26 years STANDARD_DEVIATION 16.43 • n=206 Participants
Gender Female	431 Participants n=99 Participants	232 Participants n=107 Participants	663 Participants n=206 Participants
Gender Male	281 Participants n=99 Participants	113 Participants n=107 Participants	394 Participants n=206 Participants
Smoking Status Never	359 participants n=99 Participants	149 participants n=107 Participants	508 participants n=206 Participants
Smoking Status Current	156 participants n=99 Participants	81 participants n=107 Participants	237 participants n=206 Participants
Smoking Status Former	197 participants n=99 Participants	115 participants n=107 Participants	312 participants n=206 Participants
Duration of Asthma	12.4 years STANDARD_DEVIATION 11.3 • n=99 Participants	12.8 years STANDARD_DEVIATION 11.9 • n=107 Participants	12.5 years STANDARD_DEVIATION 11.4 • n=206 Participants

PRIMARY outcome

Timeframe: At the middle and end of the 12 week treatment period

Population: Basis is the ITT population

The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome).

Outcome measures

Outcome measures
Measure	Alvesco n=712 Participants 320 mcg/day or 640 mcg/day	Usual Asthma Care and Dosage n=345 Participants as chosen by the Primary Care Physician
Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)	-0.76 points on a scale Standard Deviation 0.97	-0.37 points on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: At baseline and at week 12

Population: Basis is the ITT population

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".

Outcome measures

Outcome measures
Measure	Alvesco n=712 Participants 320 mcg/day or 640 mcg/day	Usual Asthma Care and Dosage n=345 Participants as chosen by the Primary Care Physician
Change in Patient Assessment of Asthma Control Not reported	6 participants	4 participants
Change in Patient Assessment of Asthma Control Improvement	422 participants	132 participants
Change in Patient Assessment of Asthma Control Non-Improvement	284 participants	209 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Alvesco

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Asthma Care and Dosage

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alvesco n=741 participants at risk 320 mcg/day or 640 mcg/day	Usual Asthma Care and Dosage n=346 participants at risk as chosen by the Primary Care Physician
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.13% 1/741 • Number of events 1 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.	0.00% 0/346 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.13% 1/741 • Number of events 1 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.	0.00% 0/346 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.
Hepatobiliary disorders Cholelithiasis	0.13% 1/741 • Number of events 1 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.	0.00% 0/346 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.
Injury, poisoning and procedural complications Clavicle fracture	0.13% 1/741 • Number of events 1 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.	0.00% 0/346 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.13% 1/741 • Number of events 1 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.	0.00% 0/346 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.13% 1/741 • Number of events 1 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.	0.00% 0/346 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.
Gastrointestinal disorders Intestinal obstruction	0.13% 1/741 • Number of events 1 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.	0.00% 0/346 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.
Cardiac disorders Myocardial infarction	0.00% 0/741 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.	0.29% 1/346 • Number of events 1 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.

Other adverse events

Adverse event data not reported

Additional Information

AstraZeneca Clinical Study Information Center

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60