## Protocol Section
### Identification Module
**NCT ID:** NCT00574379

**Brief Title:** Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

**Official Title:** A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen

#### Organization Study ID Info
**ID:** BILA 2607/RAE
#### Organization
**Class:** INDUSTRY
**Full Name:** Faes Farma, S.A.
#### Secondary ID Infos
**ID:** CTFZ07001
### Status Module
#### Completion Date
**Date:** 2008-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-15

**Type:** ACTUAL

**Last Update Submit Date:** 2019-02-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-03

**Type:** ACTUAL

#### Start Date
**Date:** 2007-12

**Status Verified Date:** 2019-02

#### Study First Post Date
**Date:** 2007-12-17
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-14
**Study First Submit QC Date:** 2007-12-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

**Class:** INDUSTRY

**Name:** Allied Research International

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Faes Farma, S.A.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.

### Conditions Module

**Conditions:**

- Seasonal Allergic Rhinitis

- Hay Fever

- Allergic Conjunctivitis

- Hypersensitivity

**Keywords:**

- Allergic Rhinitis

- Mountain Cedar Pollen

- Pollen Allergy

- Rhinoconjunctivitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 805

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Bilastine 20mg once per day

**Intervention Names:**

- Drug: Bilastine

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Bilastine 20mg twice per day

**Intervention Names:**

- Drug: Bilastine

**Label:** 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Bilastine 10mg once per day

**Intervention Names:**

- Drug: Bilastine

**Label:** 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Bilastine 10mg twice per day

**Intervention Names:**

- Drug: Bilastine

**Label:** 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Intervention Names:**

- Drug: Placebo

**Label:** 5

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

- 3

- 4

**Description:** Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets

**Name:** Bilastine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 5

**Description:** Placebo tablets twice daily for 14 days

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in nasal symptom scores

**Time Frame:** 14 days

#### Secondary Outcomes

**Measure:** Change in ocular symptom scores and quality of life scores; standard safety assessments

**Time Frame:** 14 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms
* documentation of a positive skin test within one year of screening to Mountain Cedar allergen

Exclusion Criteria:

* significant medical condition
* significant nasal abnormality
* significant cardiac condition
* recent infection
* use of other allergy medication during the study

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Oklahoma Allergy and Asthma Clinic

**State:** Oklahoma

**Zip:** 73104

**Location 2:**

**City:** Austin

**Country:** United States

**Facility:** MetaClin Research Inc.

**State:** Texas

**Zip:** 78704

**Location 3:**

**City:** Austin

**Country:** United States

**Facility:** Austin Clinical Research

**State:** Texas

**Zip:** 78750

**Location 4:**

**City:** Austin

**Country:** United States

**Facility:** Lovelace Scientific Resources

**State:** Texas

**Zip:** 78759

**Location 5:**

**City:** Kerrville

**Country:** United States

**Facility:** Kerrville Research Associates

**State:** Texas

**Zip:** 78028-6071

**Location 6:**

**City:** San Antonio

**Country:** United States

**Facility:** Biogenics Research Institute

**State:** Texas

**Zip:** 78229

**Location 7:**

**City:** San Antonio

**Country:** United States

**Facility:** DGD Research

**State:** Texas

**Zip:** 78229

**Location 8:**

**City:** San Antonio

**Country:** United States

**Facility:** Diagnostics Research Group

**State:** Texas

**Zip:** 78229

**Location 9:**

**City:** San Antonio

**Country:** United States

**Facility:** Southwest Allergy and Asthma Centre

**State:** Texas

**Zip:** 78229

**Location 10:**

**City:** San Antonio

**Country:** United States

**Facility:** Sylvana Research Associates

**State:** Texas

**Zip:** 78229

**Location 11:**

**City:** San Antonio

**Country:** United States

**Facility:** Live Oak Allergy and Asthma

**State:** Texas

**Zip:** 78233

**Location 12:**

**City:** Waco

**Country:** United States

**Facility:** Allergy & Asthma Care of Waco

**State:** Texas

**Zip:** 76708

**Location 13:**

**City:** Waco

**Country:** United States

**Facility:** Allergy Asthma Research Institute

**State:** Texas

**Zip:** 76712

#### Overall Officials

**Official 1:**

**Affiliation:** Faes Farma, S.A.

**Name:** Ander Sologuren, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Sylvana Research Associates

**Name:** Paul Ratner, MD

**Role:** PRINCIPAL_INVESTIGATOR

## 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: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000007154

- Term: Immune System 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: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: HIGH

- As Found: Hypersensitivity

- ID: M15049

- Name: Rhinitis

- Relevance: HIGH

- As Found: Rhinitis

- ID: M30545

- Name: Rhinitis, Allergic

- Relevance: HIGH

- As Found: Allergic Rhinitis

- ID: M2454

- Name: Hyperthermia

- Relevance: LOW

- As Found: Unknown

- ID: M8464

- Name: Fever

- Relevance: LOW

- As Found: Unknown

- ID: M6455

- Name: Conjunctivitis

- Relevance: HIGH

- As Found: Conjunctivitis

- ID: M9345

- Name: Rhinitis, Allergic, Seasonal

- Relevance: HIGH

- As Found: Seasonal Allergic Rhinitis

- ID: M6457

- Name: Conjunctivitis, Allergic

- Relevance: HIGH

- As Found: Allergic 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: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System 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: D000065631

- Term: Rhinitis, Allergic

- ID: D000006255

- Term: Rhinitis, Allergic, Seasonal

- ID: D000003231

- Term: Conjunctivitis

- ID: D000003233

- Term: Conjunctivitis, Allergic

- ID: D000006967

- Term: Hypersensitivity

### Misc Info Module

- Version Holder: 2024-05-24
