Trial Outcomes & Findings for Efficacy of SLITone in House Dust Mite Allergic Patients (NCT NCT00633919)

Results Overview

Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40. The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

124 participants

Primary outcome timeframe

8 weeks

Results posted on

2011-06-08

Participant Flow

First subject first visit: 22 June 2006

Participant milestones

Participant milestones
Measure	Active SLITone Dermatophagoides Mix	Placebo SLITone Placebo
Overall Study STARTED	63	61
Overall Study COMPLETED	36	39
Overall Study NOT COMPLETED	27	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of SLITone in House Dust Mite Allergic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=63 Participants SLITone Dermatophagoides Mix	Placebo n=61 Participants SLITone Placebo	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants	61 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	32 years STANDARD_DEVIATION 8.0 • n=5 Participants	30 years STANDARD_DEVIATION 9.0 • n=7 Participants	31 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Spain	63 participants n=5 Participants	61 participants n=7 Participants	124 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2008. All available data were used to their full extent, but no imputation of data was performed.

Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40. The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).

Outcome measures

Outcome measures
Measure	Active n=36 Participants SLITone Dermatophagoides Mix	Placebo n=39 Participants SLITone Placebo
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008	4.4 Scores on a scale Standard Deviation 5.9 • Interval 2.12 to 6.71	4.7 Scores on a scale Standard Deviation 5.4 • Interval 2.45 to 6.88

SECONDARY outcome

Timeframe: 8 weeks

Population: Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2007. All available data were used to their full extent, but no imputation of data was performed.

Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40. The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject).

Outcome measures

Outcome measures
Measure	Active n=48 Participants SLITone Dermatophagoides Mix	Placebo n=49 Participants SLITone Placebo
Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007	4.1 Scores on a scale Standard Deviation 5.1	3.6 Scores on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 8 weeks

Population: All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.

The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: "much worse", "worse", "the same", "better", or "much better". The categories "much better" or "better" were grouped as "improved". The categories "the same", "worse" or "much worse" were grouped as "not improved".

Outcome measures

Outcome measures
Measure	Active n=37 Participants SLITone Dermatophagoides Mix	Placebo n=41 Participants SLITone Placebo
Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008 Subject evaluation: Not improved	8 Participants	13 Participants
Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008 Subject evaluation: Missing data	1 Participants	0 Participants
Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008 Subject evaluation: Improved	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.

The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: "much worse", "worse", "the same", "better", or "much better". The categories "much better" or "better" were grouped as "improved". The categories "the same", "worse" or "much worse" were grouped as "not improved".

Outcome measures

Outcome measures
Measure	Active n=37 Participants SLITone Dermatophagoides Mix	Placebo n=41 Participants SLITone Placebo
Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008 Investigator evaluation: Improved	30 Participants	24 Participants
Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008 Investigator evaluation: Not improved	7 Participants	17 Participants
Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008 Investigator evaluation: Missing data	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All analyses were on all randomised participants (full analysis set) with data in 2007: All available data were used to their full extent, but no imputation of data was performed.

The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: "much worse", "worse", "the same", "better", or "much better". The categories "much better" or "better" were grouped as "improved". The categories "the same", "worse" or "much worse" were grouped as "not improved".

Outcome measures

Outcome measures
Measure	Active n=47 Participants SLITone Dermatophagoides Mix	Placebo n=47 Participants SLITone Placebo
Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007 Subject evalution: Improved	30 Participants	33 Participants
Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007 Subject evaluation: Not improved	17 Participants	14 Participants
Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007 Investigator evaluation: Improved	33 Participants	30 Participants
Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007 Investigator evaluation: Not improved	14 Participants	17 Participants

Adverse Events

Active

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=63 participants at risk SLITone Dermatophagoides Mix	Placebo n=61 participants at risk SLITone Placebo
Infections and infestations Perianal abscess	0.00% 0/63	1.6% 1/61 • Number of events 1
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/63	1.6% 1/61 • Number of events 1
Musculoskeletal and connective tissue disorders Femur fracture	1.6% 1/63 • Number of events 1	0.00% 0/61
Injury, poisoning and procedural complications Road traffic accident	1.6% 1/63 • Number of events 1	0.00% 0/61

Other adverse events

Other adverse events
Measure	Active n=63 participants at risk SLITone Dermatophagoides Mix	Placebo n=61 participants at risk SLITone Placebo
Infections and infestations Bronchitis	6.3% 4/63 • Number of events 4	3.3% 2/61 • Number of events 2
Infections and infestations Influenza	20.6% 13/63 • Number of events 16	14.8% 9/61 • Number of events 10
Infections and infestations Nasopharyngitis	14.3% 9/63 • Number of events 17	23.0% 14/61 • Number of events 18
Infections and infestations Upper respiratory tract infection	6.3% 4/63 • Number of events 5	1.6% 1/61 • Number of events 1
Vascular disorders Hypertension	6.3% 4/63 • Number of events 4	0.00% 0/61

Additional Information

Santiago Martín - Trial Manager

ALK-Abelló S.A.

Phone: +34 913276127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee ALK must receive copies of any intended communication in advance of publication (at least 15 working days for an abstract or oral presentation and 45 working days for a journal submission). ALK will review the communications for accuracy (thus avoiding potential discrepancies with submissions to health authorities), verify that confidential information is not being inadvertently divulged and provide any relevant supplementary information.
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Restriction type: OTHER