Clinical Trial: Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Clinical Trial Investigating the Efficacy and Safety of Pangramin SLIT HDM-mix in Chinese Population With House Dust Mite Induced <
Brief Summary:
Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or without asthma.
Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy.
This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix.
Detailed Summary:
Extensive clinical experience has been gained due to the widespread use of Pangramin® SLIT and other SLIT products as named patient products, both with respect to the types and the frequencies of the adverse events(AEs) observed. No safety concerns have been found.
The optimal therapeutic dose range regarding SLIT is not fully elucidated. The fate of the allergen after sublingual administration is not known in detail, i.e. to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients etc. The relationship between dose and effect is thus not fully elucidated. The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events. As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home, the dosage at this trial will be the same as marketed product.
Sponsor: ALK-Abelló A/S
Current Primary Outcome:
- The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). ]
Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
- = Mild symptoms.
- = Moderate symptoms. 3= Severe symptoms.
The six symptoms are classified in 2 groups as follows:
Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
- The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Baseline: From V1 date(We
Original Primary Outcome:
- The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Month 11 and 12. ]
- The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Months 11-12. ]
Current Secondary Outcome:
- The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). ]
Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.
A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
- = Mild symptoms.
- = Moderate symptoms. 3= Severe symptoms. The 4 symptoms are as follows: Runny nose, Blocked nose, Sneezing, Itchy nose. The 4 symptom scores were summed to obtain the rhinitis symptoms score with range 0(best) to 12(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
- The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). ]
Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.
A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
- = Mild symptoms.
- = Moderate symptoms. 3= Severe symptoms. The 2 symptoms as follows: Gritty feeling/red/itchy eyes, Watery eyes. The 2 symptom scores were summed to obtain the conjunctivitis symptoms score with range 0(best) to 6(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
- The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). ]
Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.
A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows:
0 = No symptoms.
- = Mild symptoms.
- = Moderate symptoms. 3= Severe symptoms. The 4 symptoms as follows: Cough, Wheeze, Chest tightness/shortness of breath (dyspnoea), Exercise induced symptoms. The 4 symptom scores were summed to obtain the asthma symptoms score with range 0(best) to 12(worst).
Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
- Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Total study year ]A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days.
- The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated. [ Time Frame: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52). ]
The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question 'How have your nasal complaints been today?' from 0 = no symptoms to 10 = severe symptoms.
The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization
Original Secondary Outcome:
- The change from baseline in rhinitis symptom score at 11 - 12 months. [ Time Frame: Month 11-12. ]
- The change from baseline in conjunctivitis symptom score at 11 - 12 months. [ Time Frame: Months 11-12 ]
- The change from baseline in asthma symptom score at 11 - 12 months. [ Time Frame: Months 11-12. ]
- Number of healthy days in the study. [ Time Frame: Months 11-12. ]A healthy day is a day without rhinoconjunctivitis symptoms and without any intace of rescue medication.
- Nasal complain scores on visual analog scale. [ Time Frame: Months 11-12. ]The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question 'How have your nasal complaints been today?' from 0 = no symptoms to 10 = severe symptoms.
- The change from baseline in Rhinitis Quality of life questionnaire at 11 - 12 months. [ Time Frame: Months 11-12. ]
- Comparing overall rhinoconjunctivitis symptoms the year before the trial with the trial year. [ Time Frame: Months 11-12 ]Global assessment of rhinoconjunctivitis symtom after treatment.
- Score of Rhinoconjunctivitis Rescue Medication Use. [ Time Frame: Months 11-12. ]Patients are instructed to report their use of specific rescue medication via the patient diary cards.
- The change from baseline in Asthma Quality of life questionnaire at 11 - 12 months. [ Time Frame: Months 11-12. ]
- Score of Asthma Rescue Medication Use. [ Time Frame: Months 11-12. ]Patients are instructed to report their use of specific rescue medication via the patient diary cards.
Information By: ALK-Abelló A/S
Dates:
Date Received: April 27, 2012
Date Started: October 2009
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016
