ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000336583

Ethics application status

Approved

Date submitted

22/01/2015

Date registered

14/04/2015

Date last updated

14/04/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Effects Of Dual, Inhaled Long-Acting Bronchodilators on Complex Lung Mechanics in Chronic Obstructive Pulmonary Disease

Scientific title

The effects of administration of dual long-acting bronchodilators (beta-agonists and muscarinic-antagonists), compared to mono therapy, on complex lung mechanics in patients with mild to moderate chronic obstructive pulmonary disease

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1166-4714

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Obstructive Pulmonary Disease

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

At each of the four study visits, participants will have baseline lung function and complex lung mechanics (forced oscillation technique [FOT] and multiple breath nitrogen washout [MBNW]) measured. They will then be administered a single dose of either indacaterol 150 microg, glycopyrronium 50 microg, glycopyrronium/indacaterol 50/110 microg combination, or salmeterol 50 microg, via oral inhalation route. The lung function and complex lung mechanics will then be repeated at pre-specified time intervals up to 2 hours post-administration. Each study visit will be separated by a period of at least 48 hours to ensure washout of the previous medication.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Each participant acts as their own control. The post-bronchodilator lung function measurements are compared to the pre-bronchodilator values at each visit.

Control group

Active

Outcomes

Primary outcome [1]

The change in forced oscillation technique (FOT) parameters (resistance and reactance) following administration of combination glycopyrronium/indacaterol compared to glycopyrronium alone

Timepoint [1]

2 hours post-administration at each study visit

Primary outcome [2]

The change in forced oscillation technique (FOT) parameters (resistance and reactance) following administration of combination glycopyrronium/indacaterol compared to indacaterol alone

Timepoint [2]

2 hours post-administration at each study visit

Secondary outcome [1]

Mean FOT parameters (resistance and reactance) following administration of glycopyrronium/indacaterol combination, compared to pre-bronchodilator values

Timepoint [1]

2 hours post-administration at each study visit

Secondary outcome [2]

The change in MBNW parameters (lung clearance index, Sacin and Scond) following administration of combination glycopyrronium/indacaterol compared to glycopyrronium alone

Timepoint [2]

2 hours post-administration at each study visit

Secondary outcome [3]

The change in MBNW parameters (lung clearance index, Sacin and Scond) following administration of combination glycopyrronium/indacaterol compared to indacaterol alone

Timepoint [3]

2 hours post-administration at each study visit

Secondary outcome [4]

Mean MBNW parameters (lung clearance index, Sacin and Scond) following administration of glycopyrronium/indacaterol combination, compared to pre-bronchodilator values

Timepoint [4]

2 hours post-administration at each study visit

Secondary outcome [5]

The time course of change in forced oscillation technique (FOT) parameters (resistance and reactance at each of the pre-specified time points) following administration of indacaterol compared to salmeterol

Timepoint [5]

1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120 minutes post-administration at each study visit

Eligibility

Key inclusion criteria

Adults with physician-diagnosed mild-moderate chronic obstructive pulmonary disease, with a history of current or past smoking (total exposure > 10 pack years)

Minimum age

40 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

* Use of glycopyrronium, indacaterol, salmeterol or any other LAMA or LABA within the previous 4 weeks (unless able to undergo a 2 week washout period)
* Documented hypersensitivity to, or intolerance of, beta-agonists or anti-cholinergic therapies
* Significant respiratory infection or documented exacerbation of COPD within the previous 6 weeks
* Other active or chronic respiratory pathologies (for example, interstitial lung disease, asthma, chest wall pathology causing ventilatory restriction)
* Past history of lung surgery (including lobectomy or pneumonectomy, but not lung biopsy) or thoracic radiation therapy (excluding isolated mediastinal radiation therapy with no evidence of subsequent pulmonary fibrosis)
* Any major comorbidities deemed to impact on respiratory physiology or symptoms, including severe on uncontrolled heart failure, morbid obesity, muscular or neurological disorders causing respiratory muscle weakness or dysfunctional swallowing
* History of severe renal or hepatic impairment
* Unable to perform lung function testing at the enrollment visit
* Dependence on domiciliary supplemental oxygen, unable to go without for at least 1 hour
* Women who are breast feeding, pregnant, or unwilling to avoid pregnancy during the study period
* Unable to provide informed consent
* Current enrolment in other trials

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Eligibility determined by the lead investigator and informed consent obtained. The study is non-blinded and there is no allocation concealment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The study medications will be administered in a random order according to a computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Salmeterol (comparison with indacaterol) is unblinded due to the nature of the medication delivery (different inhaler devices). Indacaterol, glycopyrronium and the indacaterol/glycopyrronium combination are blinded.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

* Power calculations are based on pharmacodynamic data of indacaterol published by Bauwens et al. This data showed an 12% increase in the mean peak FVC (a better correlate of small airway function than FEV1) following a single 150 microgram dose of indacaterol administered via Breezhaler. Using a unimean power calculation (at a power of 80% and a significance of 0.05), the number of subjects required to detect this increase is 25.
* The change in mean FOT and MBNW parameters between pre- and post-bronchodilator testing will be analysed by paired t-test
* The relationship between change in FOT/MBNW parameters following glycopyrronium/indacaterol combination administration, indacaterol and glycopyrronium mono-administration will be assessed by 2-way repeated measures ANOVA
* The relationship between the time course of FOT parameter changes for indacaterol and salmeterol will be assessed by a mixed-effects model, as well as mean area under the curve by paired t-test

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

21/01/2015

Actual

18/02/2015

Date of last participant enrolment

Anticipated

17/02/2017

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

25

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Concord Repatriation Hospital - Concord

Recruitment postcode(s) [1]

2137 - Concord

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Woolcock Institute of Medical Research

Address [1]

431 Glebe Point Rd,
GLEBE NSW 2037

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Woolcock Institute of Medical Research

Address

431 Glebe Point Rd,
GLEBE NSW 2037

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District HREC - Concord

Ethics committee address [1]

Executive Unit, KGV Building
Royal Prince Alfred Hospital
Missenden Rd,
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/08/2014

Approval date [1]

11/11/2014

Ethics approval number [1]

HREC/14/CRGH/179

Summary

Brief summary

This projects aims to study the effects of different inhaled bronchodilator medications used in the management of COPD. Clinical trials have demonstrated their effects on the large airways of the lungs, however their effects on the small airways are not yet known. This project will use sensitive tests of small airway function to identify the effects of bronchodilator therapy on the small airways in COPD. Specifically, we aim to determine if two different classes of bronchodilators have a greater effect when given in combination than when given alone. We hope to use this information to enhance our knowledge of how these medications work, which may help us improve the treatment of patients with COPD.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Greg King

Address

Woolcock Institute of Medical Research 431 Glebe Point Road, Glebe NSW 2037

Country

Australia

Phone

+61 2 9114 0000

Fax

Email

ggk@woolcock.org.au

Contact person for public queries

Name

Stephen Milne

Address

Woolcock Institute of Medical Research 431 Glebe Point Road, Glebe NSW 2037

Country

Australia

Phone

+61 2 9114 0000

Fax

Email

stephen.milne@woolcock.org.au

Contact person for scientific queries

Name

Stephen Milne

Address

Woolcock Institute of Medical Research 431 Glebe Point Road, Glebe NSW 2037

Country

Australia

Phone

+61 2 9114 0000

Fax

Email

stephen.milne@woolcock.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Milne S, Hammans C, Watson S, Farah CS, Thamrin C,... [More Details]

Documents added automatically

No additional documents have been identified.