## Protocol Section
### Identification Module
**NCT ID:** NCT01216579

**Brief Title:** Steroid Titration Against Mannitol IN Asthma

**Official Title:** Titrating Inhaled Steroid Dose Against Mannitol Hyper-responsiveness or BTS Outcomes: Comparative Effects on Asthma Exacerbations Over 1 Year

#### Organization Study ID Info
**ID:** FARD002
#### Organization
**Class:** OTHER
**Full Name:** University of Dundee
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-10-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-10-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Start Date
**Date:** 2004-03

**Status Verified Date:** 2008-03

#### Study First Post Date
**Date:** 2010-10-07
**Type:** ESTIMATED
**Study First Submit Date:** 2010-10-06
**Study First Submit QC Date:** 2010-10-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Dundee

#### Responsible Party

**Old Name Title:** Professor Brian Jonathon Lipworth

**Old Organization:** University of Dundee

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The investigators hypothesise that titration of asthma medication against mannitol challenge results will reduce the number of mild asthma exacerbations, in one year, when compared with titration against BTS guidelines. To test this hypothesis the investigators propose a primary care, parallel treatment, patient blinded study in which matched groups of asthmatic patients will be treated in accordance either with BTS guidelines or with our treatment algorithm dependent on mannitol challenge result.

Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of airway inflammation, in the long term treatment of asthma in comparison to BTS guidelines.

### Conditions Module

**Conditions:**

- Asthma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 164

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Asthmatic patients managed as per British Thoracic Society guidelines by symptoms and lung function.

**Intervention Names:**

- Other: mannitol (an airway challenge agent)

**Label:** Reference arm

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Group of asthmatic patients managed according to their mannitol challenge.

**Intervention Names:**

- Other: mannitol (an airway challenge agent)

**Label:** Mannitol managed arm

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mannitol managed arm

- Reference arm

**Name:** mannitol (an airway challenge agent)

**Type:** OTHER

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female asthmatics aged \>/= 16 years
* Females must be non pregnant and non lactating
* FEV1 \>/= 50% predicted
* Mannitol PD10 \</= 635 mg at end of step down period
* No recent exacerbations of asthma requiring oral prednisolone in the previous 3 months
* Able to perform all the techniques necessary to carry out the challenge testing and lung function and compliant with taking the study medication
* Good inhaler technique which will be reinforced at each study visit

Exclusion Criteria:

* Male or female patients aged 15 or below
* FEV1 \</= 50% predicted
* Patients who are currently taking a pulse of oral corticosteroids
* Patients with the following concomitant illnesses:bronchiectasis, allergic bronchopulmonary aspergillosis, COPD, heart failure, pulmonary fibrosis, rhino-sinusitis with polyps
* Immunocompromised patients
* Patients with recurrent LRTI
* Patients with documented aspirin induced asthma on LRTAs
* Pregnancy
* Known or suspected hypersensitivity to ICS or other excipients of the MDIs
* HIV/Hepatitis B or C positive

**Maximum Age:** 65 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** University of Dundee

**Name:** Brian J Lipworth, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.

**PMID:** 28065396

**Citation:** Anderson WJ, McFarlane LC, Lipworth BJ. Prospective follow-up of novel markers of bone turnover in persistent asthmatics exposed to low and high doses of inhaled ciclesonide over 12 months. J Clin Endocrinol Metab. 2012 Jun;97(6):1929-36. doi: 10.1210/jc.2011-3410. Epub 2012 Mar 21.

**PMID:** 22438232

**Citation:** Lipworth BJ, Short PM, Williamson PA, Clearie KL, Fardon TC, Jackson CM. A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA trial. Chest. 2012 Mar;141(3):607-615. doi: 10.1378/chest.11-1748. Epub 2011 Oct 13.

**PMID:** 21998259

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- 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

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Intervention Browse Module - Ancestors

- ID: D000004234

- Term: Diuretics, Osmotic

- ID: D000004232

- Term: Diuretics

- ID: D000045283

- Term: Natriuretic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11342

- Name: Mannitol

- Relevance: HIGH

- As Found: Abuse

- ID: M7411

- Name: Diuretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008353

- Term: Mannitol

### Misc Info Module

- Version Holder: 2024-05-24
