Skip to content

Combination Therapy with Tiotropium in Chronic Obstructive Pulmonary Disease (COTTS)

Combination therapy with tiotropium and formoterol in moderate to severe Chronic Obstructive Pulmonary Disease: effects on exercise capacity and health related quality of life

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000079347
Acronym
COTTS
Enrollment
40
Registered
2008-02-13
Start date
2007-08-01
Completion date
2007-08-01
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Tiotropium (Spiriva) and formoterol (Oxis) are both currently available prescription medicines for people with COPD. Each of them has a particular effect on the airway. They are usually prescribed independently although it is quite possible for them to be prescribed together. Therefore some people with COPD may already be taking one or both of them. People participating in this study will take a regular dose of tiotropium plus a placebo for 6 weeks and a regular dose of tiotropium plus formoterol for 6 weeks. There will be 2 weeks between each 6 week period when participants will take only tiotropium.

Interventions

At the initial visit all subjects will be commenced on Tiotropium 18mcg daily via inhaler. Subjects will be randomised to receive either placebo or formoterol 12mcg bd via inhaler for 6 weeks. There will then be a 2 week washout period for formoterol (not Tiotropium). Subjects will then crossover to the alternate arm of therapy for a further 6 weeks.

Sponsors

Centre for Clinical Research and effective practice (CCRep)
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Chronic Obstructive Airways Disease (COPD).

Exclusion criteria

Myocardial infarction within 3 months of enrolment in the study. Prostatism Glaucoma

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026