The effect of twice daily aclidinium bromide/formoterol fumarate 340/12 mcg vs. once daily tiotropium 'respimat' 5mcg on static and dynamic hyperinflation in patients with COPD during 24 hours.

The effect of twice daily aclidinium bromide/formoterol fumarate 340/12 mcg vs. once daily tiotropium 'respimat' 5mcg on static and dynamic hyperinflation in patients with COPD during 24 hours. - BOTH study (BrOchodilaTion Hyperinflation)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49226

Enrollment

Registered

2017-05-03

Start date

2017-06-26

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Chronic obstructive pulmonary disease (COPD)

Interventions

Aclidinium bromide/formoterol fumarate (Duaklir Genuair), 1 dose of 340/12mcg per 12 hours via DPI. Tiotropium (Spiriva Respimat), 2 doses of 2,5 mcg once per 24 hours via PMDI.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with COPD with static hyperinflation above the higher limit of normal defined as 1,64 times the standard deviation above the predicted value.

Exclusion criteria

Exclusion criteria: Patients treated with oral corticosteroids and/or antibiotics for an exacerbation and/or lower respiratory tract infection in the 4 weeks prior to screening. Patients with hypercapnia (>= 6.5 kPa). Patients unable to perform bodybox measurements Known respiratory disorders other than COPD which may impact the efficacy of the study drug. Patients with clinically significant cardiovascular conditions.

Design outcomes

Primary

Measure	Time frame
To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour static hyperinflation.	—

Secondary

Measure	Time frame
To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour spirometry. To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour dynamic hyperinflation. To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI twice daily compared to tiotropium respimat 5mcg PMDI once daily on 24 hour respiratory symptoms. To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI twice daily compared to tiotropium respimat 5mcg PMDI once daily on sleep quality. To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI twice daily compared to tiotropium respimat 5mcg PMDI once daily on nighttime physical activity, as an inverse surrogate for sleep quality.	—

Measure

Time frame

To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour spirometry. To explore the effect of of aclidinium/formoterol 340/12 mcg DPI twice daily compared to tiotropium respimat 5 mcg PMDI once daily on 24 hour dynamic hyperinflation. To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI twice daily compared to tiotropium respimat 5mcg PMDI once daily on 24 hour respiratory symptoms. To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI twice daily compared to tiotropium respimat 5mcg PMDI once daily on sleep quality. To explore the effect of aclidinium bromide/formoterol fumarate 340/12 mcg DPI twice daily compared to tiotropium respimat 5mcg PMDI once daily on nighttime physical activity, as an inverse surrogate for sleep quality.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)