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

NCT ID: NCT00117182

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Dry powder mannitol

Intervention Type: DRUG

Budesonide 400mcg administered via turbuhaler

Intervention Type: DRUG

Ipratropium bromide 80mcg

Intervention Type: DRUG

Salbutamol 400mcg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;
• fever;
• antibiotic treatment (for respiratory infection).

Exclusion Criteria

• 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.
• Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of, study entry.
• Known intolerance to mannitol.
• Uncontrolled hypertension - systolic blood pressure (BP) > 200 mmHg and or diastolic BP > 100 mmHg.
• Planned pulmonary rehabilitation.
• Have had major abdominal, chest or brain surgery in the three months prior to enrolment.
• Have known cerebral, aortic or abdominal aneurysm.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntara

INDUSTRY

Sponsor Role: lead

Principal Investigators

Alvin Ing, MBBS

Role: PRINCIPAL_INVESTIGATOR

Bankstown Hospital

Martin Coffey, MBBS

Role: PRINCIPAL_INVESTIGATOR

Rosebud Medical Centre

David Langton, MBBS

Role: PRINCIPAL_INVESTIGATOR

Peninsula Chest Clinic, Frankston

Chris Steinfort, MBBS

Role: PRINCIPAL_INVESTIGATOR

The Rooms of Dr Steinfort, Geelong

Trevor WIlliams, MBBS

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Peter Frith, MBBS

Role: PRINCIPAL_INVESTIGATOR

Flinders Medical Centre

Michael Chia, MBBS

Role: PRINCIPAL_INVESTIGATOR

Respiratory Research Foundation, Toorak Gardens

Maureen McKeirnan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Brisbane South Medical Centre

Fred de Looze, MBBS

Role: PRINCIPAL_INVESTIGATOR

Centre for General Practice for Clinical Trials Unit, Inala

Michael Crookes, MBBS

Role: PRINCIPAL_INVESTIGATOR

Peninsula Medical Centre

Alan James, MBBS

Role: PRINCIPAL_INVESTIGATOR

Sir Charles Gairdner Hospital

Phillip Thompson, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mount Medical Centre

Locations

Respiratory Clinic

Sydney, New South Wales, Australia

Peninsula Medical Centre

Umina, New South Wales, Australia

Wesley Medical Centre

Auchenflower, Queensland, Australia

Brisbane South Clinical Clinical Research Centre

Brisbane, Queensland, Australia

Inala Health Centre

PO BOx 52, Inala, Queensland, Australia

Flinders University

Bedford Park, South Australia, Australia

Respiratory Research Foundation Clinical Trial Centre

Toorak Gardens, South Australia, Australia

Peninsula Chest Clinic

Frankston, Victoria, Australia

The rooms of Dr Chris Steinfort

Geelong, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Rosebud Medical Centre

Rosebud, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Mount Medical Centre

Perth, Western Australia, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 9309990 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11896899 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12885977 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14555564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15649849 (View on PubMed)

Other Identifiers

DPM-COPD-201

Identifier Type: -

Identifier Source: org_study_id