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Lung Diseases, ObstructivePhase 2NCT00117182

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

A Phase 2 study testing Dry powder mannitol, Budesonide 400mcg administered via turbuhaler and Ipratropium bromide 80mcg in people with Lung Diseases, Obstructive, run by Syntara at 13 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Lung Diseases, Obstructive
What is being tested?
Dry powder mannitol, Budesonide 400mcg administered via turbuhaler and Ipratropium bromide 80mcg
How many people
140 participants
Where
13 sitesAustralia
Study dates
Jul 2005to Aug 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Australia13 sites

  • Wesley Medical Centre

    Auchenflower, Queensland, 4066

  • Flinders University

    Bedford Park, South Australia, 5042

  • Brisbane South Clinical Clinical Research Centre

    Brisbane, Queensland, 4152

  • Peninsula Chest Clinic

    Frankston, Victoria, 3199

  • The rooms of Dr Chris Steinfort

    Geelong, Victoria, 3220

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Mount Medical Centre

    Perth, Western Australia, 6005

  • Inala Health Centre

    PO BOx 52, Inala, Queensland, 4077

  • Rosebud Medical Centre

    Rosebud, Victoria, 3939

  • Respiratory Clinic

    Sydney, New South Wales, 2200

  • Respiratory Research Foundation Clinical Trial Centre

    Toorak Gardens, South Australia, 5056

  • Peninsula Medical Centre

    Umina, New South Wales, 2257

Other trials in Australia

About this study

Official title: A Phase II Study to Investigate Mannitol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD

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.

Being tested
Dry powder mannitol, Budesonide 400mcg administered via turbuhaler, Ipratropium bromide 80mcg, Salbutamol 400mcg
Medical subject headings
Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry powder mannitolDrug

  • Budesonide 400mcg administered via turbuhalerDrug

  • Ipratropium bromide 80mcgDrug

  • Salbutamol 400mcgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced expiratory volume in one second (FEV1)

Secondary outcomes (9)

  1. Response dose ratio (RDR)

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

  3. Lung function values

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

  5. COPD clinical control scores (CCQ)

  6. Exacerbation frequency

  7. Days on antibiotics

  8. Days off work or days unable to carry out normal activities

  9. Reversibility of airflow obstruction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2005 (estimated)
  2. Study startJul 2005
  3. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00117182
Sponsor's protocol ID
DPM-COPD-201
Status last verified
Apr 2016
First submitted
30 Jun 2005
Last updated
20 Apr 2016
Results posted
No

Publications

  • 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.

    PubMed 9309990

  • 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.

    PubMed 11896899

  • 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.

    PubMed 12885977

  • 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.

    PubMed 14555564

  • 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.

    PubMed 15649849

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dry powder mannitol, Budesonide 400mcg administered via turbuhaler and Ipratropium bromide 80mcg in people with Lung Diseases, Obstructive, run by Syntara at 13 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced expiratory volume in one second (FEV1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00117182, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.

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