Allergic RhinitisPhase 3NCT01603056
Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis
A Phase 3 study testing Pangramin SLIT HDM mix. in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Pangramin SLIT HDM mix.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 617 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Feb 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
No.2, Chongwenmennei Street, Dongcheng District
Beijing, Beijing Municipality, 100730
About this study
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 Rhinitis With or Without Asthma.
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.
Read the detailed description
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.
- Conditions
- Allergic Rhinitis
- Being tested
- Pangramin SLIT HDM mix., Placebo
- Keywords
- House dust mite induced allergic rhinitis.
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pangramin SLIT HDM mix.Biological
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
PlaceboBiological
Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- = 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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 visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52).
Measured: 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 Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52).
The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better.
Measured: Visit 1 date(Week -8), Visit 9 date(Week 52).
Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated.
Measured: Visit 9 date, Week 52
The Change From Baseline in Rhinitis 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 Rhinitis 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 Rhinitis medication score range from 0 to 30. 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 set 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.
Measured: 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 Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better.
Measured: Visit 1 date(Week -8), Visit 9 date(Week 52).
The Change From Baseline in Asthma 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 Asthma 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 asthma 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 set 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 in evaluation period and divided with the days with diary.
Measured: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startOct 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Luo, Professor, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603056
- Sponsor's protocol ID
- PS-M-01
- Status last verified
- Mar 2016
- First submitted
- 27 Apr 2012
- Last updated
- 29 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Rhinitis With or Without Asthma.
- ClinicalTrials.gov ID
- NCT01603056
- Acronym / sponsor ID
- PS-M-01
- Conditions
- Allergic Rhinitis
- Keywords
- House dust mite induced allergic rhinitis.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Posted 29 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PANGRAMIN SLIT HDM MIX | Experimental | Biological: Pangramin SLIT HDM mix.PANGRAMIN SLIT HDM MIX Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| PlaceboUp-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months. | Biological | Placebo |
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. 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.
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(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
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.
10 secondary outcomes
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).
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).
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).
Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.
Time frame: 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.
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 Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
Time frame: Visit 1 date(Week -8), Visit 9 date(Week 52).
Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
Time frame: Visit 9 date, Week 52
The Change From Baseline in Rhinitis Medication 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).
The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
Time frame: Visit 1 date(Week -8), Visit 9 date(Week 52).
The Change From Baseline in Asthma Medication 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Luo, Professor principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pangramin SLIT HDM mix. in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.