Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis

NCT01603056 | Completed Phase 3 Results

• 1 other identifier: PS-M-01
• Study Type: interventional
• Target: 617
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

House dust mite induced allergic rhinitis.

Outcome Measures

Primary Outcomes (2)

• The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.

  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. 1. = Mild symptoms. 2. = 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.

  Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).

• The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.

  Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) 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 in diary.

  Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).

Secondary Outcomes (10)

• The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.

  Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).

• The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.

  Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).

• The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.

  Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).

• Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.

  Total study year

• 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.

  Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).

Study Arms (2)

PANGRAMIN SLIT HDM MIX

EXPERIMENTAL

PANGRAMIN SLIT HDM MIX Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

Biological: Pangramin SLIT HDM mix.

Placebo

PLACEBO COMPARATOR

Placebo Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

Biological: Placebo

Interventions

Pangramin SLIT HDM mix. BIOLOGICAL

Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

PANGRAMIN SLIT HDM MIX

Placebo BIOLOGICAL

Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

Placebo

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female ≥ 5 to ≤ 55 years of age.
• A history HDM induced allergic rhinitis.
• Use of medication for the control of rhinoconjunctivitis symptoms.
• Positive Skin Prick Test (SPT).
• Positive specific IgE.

You may not qualify if:

• PEF ≤ 70% of predicted value.
• History of significant symptomatic seasonal or perennial allergic rhinitis and/or asthma caused by an allergen to which the patient is regularly exposed, and sensitized (e.g. pollens, cat, dog, cockroach…except house dust mites).
• Severe asthma.
• Current symptoms of upper respiratory tract infection or other relevant infectious process.
• Current food allergies with oral allergy syndrome.
• A clinical history of chronic sinusitis.
• Current severe atopic dermatitis.
• Concomitant or previous treatment by immunotherapy.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

No.2, Chongwenmennei Street, Dongcheng District

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Vivian Wang, Sr. Medical Affairs Manager
• Organization: ALK-Abelló A/S

Vivian.Wang@alk.net

86 - 10 5166 8198

Study Officials

• Zhang Luo, Professor

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 22, 2012
• Study Start: October 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 29, 2016
• Results First Posted: April 29, 2016

Record last verified: 2016-03

Locations

CN (1)