Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD

NCT00117182 | Completed Phase 2

• 1 other identifier: DPM-COPD-201
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The effect on lung function and quality of life will then be measured and correlated with the Aridol test result.

Conditions

Lung Diseases, Obstructive

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in one second (FEV1)

Secondary Outcomes (9)

• Response dose ratio (RDR)

• Dose of provoking stimulus causing a 15%, 12% or 10% fall in FEV1 (PD15, PD12, PD10)

• Lung function values

• Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ)- total score

• COPD clinical control scores (CCQ)

Interventions

Dry powder mannitol DRUG

Budesonide 400mcg administered via turbuhaler DRUG

Ipratropium bromide 80mcg DRUG

Salbutamol 400mcg DRUG

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD (history, spirometry, symptoms including chronic cough and/or shortness of breath that is worse on exertion and/or excess sputum production)
• Aged 45 - 80 years
• Have pre-bronchodilator FEV1 \> 1.4 litres and at least 60% of predicted for height, age and gender and a post-bronchodilator FEV1 \<80% of predicted for height, age and gender
• Post-bronchodilator FEV1/FVC \< 70 %
• ≥ 10 pack years smoking history
• As determined by the investigator, are capable and willing to:
• perform all of the techniques necessary to measure lung function;
• administer the dry powder mannitol.
• Are capable of, and have given informed consent to, participating in this study in accordance with local regulations.
• The subject must be in stable clinical condition at the time of, and for a period of 14 days prior to, their recruitment into the study. Stable clinical condition is defined as lack of:
• change in sputum production (volume, colour, consistency);
• increased cough;
• worsening dyspnoea;
• increased malaise, fatigue or lethargy;
• reduction in exercise tolerance;

You may not qualify if:

• Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
• Subjects receiving treatment with inhaled corticosteroids (including combination therapies, e.g. Seretide®, Symbicort®) or oral corticosteroids within the last 6 weeks.
• Subjects who have had an exacerbation or a chest infection within the 2 weeks prior to the study.
• Subjects receiving antibiotic treatment for respiratory infection.
• Known diagnosis of asthma or allergic rhinitis.
• Myocardial infarction in the six months prior to enrolment.
• Cerebral vascular accident in the six months prior to enrolment.
• Ocular surgery in the three months prior to enrolment.
• Abdominal surgery in the three months prior to enrolment.
• Active tuberculosis (TB).
• Lung cancer or any other malignancies, which are considered by the investigator as a contraindication to participating in the study.
• Lung disease other than COPD (e.g. bronchiectasis).
• Uncontrolled insulin-dependant or non-insulin dependant diabetes, i.e. \>10% HbA1c.
• Female subjects of reproductive capability, not using a reliable form of contraception
• Inability to obtain informed consent from the subject or subject's authorised representative.

Sponsors & Collaborators

• Syntara: lead

Study Sites (13)

Respiratory Clinic

Sydney, New South Wales, 2200, Australia

Location

Peninsula Medical Centre

Umina, New South Wales, 2257, Australia

Location

Wesley Medical Centre

Auchenflower, Queensland, 4066, Australia

Location

Brisbane South Clinical Clinical Research Centre

Brisbane, Queensland, 4152, Australia

Location

Inala Health Centre

PO BOx 52, Inala, Queensland, 4077, Australia

Location

Flinders University

Bedford Park, South Australia, 5042, Australia

Location

Respiratory Research Foundation Clinical Trial Centre

Toorak Gardens, South Australia, 5056, Australia

Location

Peninsula Chest Clinic

Frankston, Victoria, 3199, Australia

Location

The rooms of Dr Chris Steinfort

Geelong, Victoria, 3220, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Rosebud Medical Centre

Rosebud, Victoria, 3939, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Mount Medical Centre

Perth, Western Australia, 6005, Australia

Location

Related Publications (5)

• Anderson SD, Brannan J, Spring J, Spalding N, Rodwell LT, Chan K, Gonda I, Walsh A, Clark AR. A new method for bronchial-provocation testing in asthmatic subjects using a dry powder of mannitol. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):758-65. doi: 10.1164/ajrccm.156.3.9701113.

  PMID: 9309990 BACKGROUND

• Brannan JD, Koskela H, Anderson SD, Chan HK. Budesonide reduces sensitivity and reactivity to inhaled mannitol in asthmatic subjects. Respirology. 2002 Mar;7(1):37-44. doi: 10.1046/j.1440-1843.2002.00357.x.

  PMID: 11896899 BACKGROUND

• Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA. Prednisolone response in patients with chronic obstructive pulmonary disease: results from the ISOLDE study. Thorax. 2003 Aug;58(8):654-8. doi: 10.1136/thorax.58.8.654.

  PMID: 12885977 BACKGROUND

• Koskela HO, Hyvarinen L, Brannan JD, Chan HK, Anderson SD. Sensitivity and validity of three bronchial provocation tests to demonstrate the effect of inhaled corticosteroids in asthma. Chest. 2003 Oct;124(4):1341-9. doi: 10.1378/chest.124.4.1341.

  PMID: 14555564 BACKGROUND

• Leuppi JD, Tandjung R, Anderson SD, Stolz D, Brutsche MH, Bingisser R, Perruchoud AP, Surber C, Knoblauch A, Andersson M, Greiff L, Chan HK, Tamm M. Prediction of treatment-response to inhaled corticosteroids by mannitol-challenge test in COPD. A proof of concept. Pulm Pharmacol Ther. 2005;18(2):83-8. doi: 10.1016/j.pupt.2004.10.005. Epub 2004 Dec 21.

  PMID: 15649849 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Obstructive

Interventions

Budesonide; Ipratropium; Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Alvin Ing, MBBS

  Bankstown Hospital

  PRINCIPAL INVESTIGATOR

• Martin Coffey, MBBS

  Rosebud Medical Centre

  PRINCIPAL INVESTIGATOR

• David Langton, MBBS

  Peninsula Chest Clinic, Frankston

  PRINCIPAL INVESTIGATOR

• Chris Steinfort, MBBS

  The Rooms of Dr Steinfort, Geelong

  PRINCIPAL INVESTIGATOR

• Trevor WIlliams, MBBS

  The Alfred

  PRINCIPAL INVESTIGATOR

• Peter Frith, MBBS

  Flinders Medical Centre

  PRINCIPAL INVESTIGATOR

• Michael Chia, MBBS

  Respiratory Research Foundation, Toorak Gardens

  PRINCIPAL INVESTIGATOR

• Maureen McKeirnan, MBBS

  Brisbane South Medical Centre

  PRINCIPAL INVESTIGATOR

• Fred de Looze, MBBS

  Centre for General Practice for Clinical Trials Unit, Inala

  PRINCIPAL INVESTIGATOR

• Michael Crookes, MBBS

  Peninsula Medical Centre

  PRINCIPAL INVESTIGATOR

• Alan James, MBBS

  Sir Charles Gairdner Hospital

  PRINCIPAL INVESTIGATOR

• Phillip Thompson, MBBS

  Mount Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 4, 2005
• Study Start: July 1, 2005
• Study Completion: August 1, 2006
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

AU (13)