## Protocol Section
### Identification Module
**NCT ID:** NCT00857779

**Brief Title:** Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

**Official Title:** A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ

#### Organization Study ID Info
**ID:** AF-H-01
#### Organization
**Class:** INDUSTRY
**Full Name:** ALK-Abelló A/S
### Status Module
#### Completion Date
**Date:** 2009-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-02-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-02-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-08

**Type:** ACTUAL

#### Start Date
**Date:** 2009-02

**Status Verified Date:** 2013-02

#### Study First Post Date
**Date:** 2009-03-09
**Type:** ESTIMATED
**Study First Submit Date:** 2009-03-05
**Study First Submit QC Date:** 2009-03-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** ALK-Abelló A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ

### Conditions Module

**Conditions:**

- Rhinitis

- Conjunctivitis

- Asthma

**Keywords:**

- allergen immunotherapy

- allergy to grass pollen

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 473

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subcutaneous immunotherapy using a slow updosing schedule

**Intervention Names:**

- Biological: subcutaneous immunotherapy

**Label:** subcutaneous immunotherapy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** subcutaneous immunotherapy using a fast updosing schedule

**Intervention Names:**

- Biological: subcutaneous immunotherapy

**Label:** subcutaneous injections

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- subcutaneous immunotherapy

- subcutaneous injections

**Description:** 7 injections

**Name:** subcutaneous immunotherapy

**Other Names:**

- AVANZ

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** IgE-blocking factor

**Time Frame:** start of treatment and 1 week after end of treatment

#### Secondary Outcomes

**Measure:** Tolerability of two different updosing schedules

**Time Frame:** throughout treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
* Lack of adequate relief with symptomatic medication during the previous grass pollen season
* Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter \>= 3mm) currently performed or not older than 60 days before screening

Exclusion Criteria:

* FEV1 \< 70% of predicted value at screening
* Bronchial asthma corresponding to GINA step 3 or more, even if controlled
* History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
* Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
* Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Erfurt

**Country:** Germany

**Facility:** Allergists' practice Dr. Kirsten Jung

**State:** Thueringen

**Zip:** D-99084

#### Overall Officials

**Official 1:**

**Affiliation:** Private practice, Erfurt, Germany

**Name:** Kirsten Jung, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Pfaar O, Jung K, Wolf H, Decot E, Kleine-Tebbe J, Klimek L, Wustenberg E. Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio. Allergy. 2012 May;67(5):630-7. doi: 10.1111/j.1398-9995.2012.02801.x. Epub 2012 Mar 3.

**PMID:** 22385366

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009668

- Term: Nose Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC01

- Name: Infections

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M4556

- Name: Asthma

- Relevance: LOW

- As Found: Unknown

- ID: M15049

- Name: Rhinitis

- Relevance: HIGH

- As Found: Rhinitis

- ID: M6455

- Name: Conjunctivitis

- Relevance: HIGH

- As Found: Conjunctivitis

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12604

- Name: Nose Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012220

- Term: Rhinitis

- ID: D000003231

- Term: Conjunctivitis

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: HIGH

- As Found: Computer

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000091369

- Term: Immunomodulating Agents

### Misc Info Module

- Version Holder: 2024-05-24
