Trial Outcomes & Findings for Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients (NCT NCT00989833)

NCT ID: NCT00989833

Last Updated: 2012-08-14

Results Overview

FEV1

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: Baseline and Visit 6
• Results posted on: 2012-08-14

Participant Flow

On Visit 1, a total of 189 patients, aged 12-67, were enrolled at 10 study sites in 2 countries: Sweden and Norway. Of 189 enrolled patients, 66 patients were randomized and allocated to study treatment on Visit 3 (7 patients in Norway and 59 patients in Sweden).

A standardized exercise test (ECT) with duration of 6 minutes, at approximately 90% of maximal aerobic capacity (as defined on Visit 1) was performed on a treadmill while breathing dry air on Visit 2. Patients with exercised induced bronchoconstriction (defined as fall in FEV1 ≥ 10% ) could be randomized on Visit 3.

Participant milestones

Measure	Budesonide/Terbutaline Budesonide once daily and terbutaline before exercise and as needed	Terbutaline Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Overall Study STARTED	21	22	23
Overall Study COMPLETED	19	19	21
Overall Study NOT COMPLETED	2	3	2

Reasons for withdrawal

Measure	Budesonide/Terbutaline Budesonide once daily and terbutaline before exercise and as needed	Terbutaline Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Overall Study Lost to Follow-up	0	1	0
Overall Study Protocol Violation	1	2	1
Overall Study Withdrawal by Subject	0	0	1
Overall Study Incorrectly randomized	1	0	0

Baseline Characteristics

Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

Baseline characteristics by cohort

Measure	Budesonide/Terbutaline n=21 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=22 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=23 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	52 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	16 Participants n=7 Participants	9 Participants n=5 Participants	36 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 6

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

FEV1

Outcome measures

Measure	Budesonide/Terbutaline n=20 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=21 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=21 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks	-5.85 Percent change Standard Deviation 6.50	0.61 Percent change Standard Deviation 10.92	-5.24 Percent change Standard Deviation 9.64

SECONDARY outcome

Timeframe: Baseline and 3 weeks

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

FEV1

Outcome measures

Measure	Budesonide/Terbutaline n=20 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=21 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=21 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks	-4.07 Percent change Standard Deviation 5.56	-1.19 Percent change Standard Deviation 8.03	-3.81 Percent change Standard Deviation 8.68

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)

Outcome measures

Measure	Budesonide/Terbutaline n=11 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=6 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=5 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Bronchial Responsiveness to Mannitol	67.26 mg Standard Deviation 141.98	-6.15 mg Standard Deviation 95.10	151.87 mg Standard Deviation 141.09

SECONDARY outcome

Timeframe: 6 weeks

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

Outcome measures

Measure	Budesonide/Terbutaline n=19 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=18 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=21 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Concentration of Exhaled Nitric Oxide	25.9 ppb Standard Deviation 20.1	35.5 ppb Standard Deviation 36.6	24.4 ppb Standard Deviation 22.4

SECONDARY outcome

Timeframe: 6 weeks

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

Mean number of as needed inhalations taken before exercise

Outcome measures

Measure	Budesonide/Terbutaline n=20 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=20 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=21 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Use of as Needed Medication	0.6 number of inhalations per day Standard Deviation 0.2	0.8 number of inhalations per day Standard Deviation 0.5	0.7 number of inhalations per day Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline e and 6 weeks

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.

Outcome measures

Measure	Budesonide/Terbutaline n=20 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=21 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=22 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)	-0.3 units on a scale Standard Deviation 0.7	-0.2 units on a scale Standard Deviation 0.8	-0.4 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 6 weeks

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

Asthma symptoms during days with exercise

Outcome measures

Measure	Budesonide/Terbutaline n=20 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=20 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=21 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Diary Recording of Asthma Symptoms	51.1 Percent of exercise days Standard Deviation 30.5	50.9 Percent of exercise days Standard Deviation 36.6	49.8 Percent of exercise days Standard Deviation 26.1

SECONDARY outcome

Timeframe: 6 weeks

Population: The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.

Outcome measures

Measure	Budesonide/Terbutaline n=21 Participants Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=22 Participants Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=23 Participants Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Number of Participants With an Adverse Event During the Study	13 Participants	13 Participants	13 Participants

Adverse Events

Budesonide/Terbutaline

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Terbutaline

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Budesonide/Formoterol

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Budesonide/Terbutaline n=21 participants at risk Budesonide once daily and terbutaline before exercise and as needed	Terbutaline n=22 participants at risk Placebo budesonide once daily and terbutaline before exercise and as needed	Budesonide/Formoterol n=23 participants at risk Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
Infections and infestations Common cold	23.8% 5/21	31.8% 7/22	21.7% 5/23
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/21	13.6% 3/22	4.3% 1/23
Gastrointestinal disorders Gastroenteritis	4.8% 1/21	0.00% 0/22	13.0% 3/23
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/21	0.00% 0/22	17.4% 4/23
General disorders Headache	4.8% 1/21	9.1% 2/22	0.00% 0/23
Injury, poisoning and procedural complications Fall	0.00% 0/21	0.00% 0/22	8.7% 2/23
General disorders Slight Fever	0.00% 0/21	9.1% 2/22	0.00% 0/23

Additional Information

Gerard Lynch

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60