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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00117182




Registration number
NCT00117182
Ethics application status
Date submitted
30/06/2005
Date registered
4/07/2005
Date last updated
20/04/2016

Titles & IDs
Public title
Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Scientific title
A Phase II Study to Investigate Mannitol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Secondary ID [1] 0 0
DPM-COPD-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Obstructive 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dry powder mannitol
Treatment: Drugs - Budesonide 400mcg administered via turbuhaler
Treatment: Drugs - Ipratropium bromide 80mcg
Treatment: Drugs - Salbutamol 400mcg

Treatment: Drugs: Dry powder mannitol


Treatment: Drugs: Budesonide 400mcg administered via turbuhaler


Treatment: Drugs: Ipratropium bromide 80mcg


Treatment: Drugs: Salbutamol 400mcg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced expiratory volume in one second (FEV1)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Response dose ratio (RDR)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Dose of provoking stimulus causing a 15%, 12% or 10% fall in FEV1 (PD15, PD12, PD10)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Lung function values
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ)- total score
Timepoint [4] 0 0
Secondary outcome [5] 0 0
COPD clinical control scores (CCQ)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Exacerbation frequency
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Days on antibiotics
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Days off work or days unable to carry out normal activities
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Reversibility of airflow obstruction
Timepoint [9] 0 0

Eligibility
Key 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).
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Respiratory Clinic - Sydney
Recruitment hospital [2] 0 0
Peninsula Medical Centre - Umina
Recruitment hospital [3] 0 0
Wesley Medical Centre - Auchenflower
Recruitment hospital [4] 0 0
Brisbane South Clinical Clinical Research Centre - Brisbane
Recruitment hospital [5] 0 0
Inala Health Centre - PO BOx 52, Inala
Recruitment hospital [6] 0 0
Flinders University - Bedford Park
Recruitment hospital [7] 0 0
Respiratory Research Foundation Clinical Trial Centre - Toorak Gardens
Recruitment hospital [8] 0 0
Peninsula Chest Clinic - Frankston
Recruitment hospital [9] 0 0
The rooms of Dr Chris Steinfort - Geelong
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Rosebud Medical Centre - Rosebud
Recruitment hospital [12] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [13] 0 0
Mount Medical Centre - Perth
Recruitment postcode(s) [1] 0 0
2200 - Sydney
Recruitment postcode(s) [2] 0 0
2257 - Umina
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4152 - Brisbane
Recruitment postcode(s) [5] 0 0
4077 - PO BOx 52, Inala
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5056 - Toorak Gardens
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3939 - Rosebud
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6005 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Syntara
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00117182
Trial related presentations / 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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Alvin Ing, MBBS
Address 0 0
Bankstown Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries