A 52-week, Placebo- and Active- Controlled (Roflumilast,... | NCT04636814 | Trialant

A 52-week, Placebo- and Active- Controlled (Roflumilast,... | NCT04636814 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHF6001 1600µg	Experimental		Drug: CHF6001 1600µg
CHF6001 3200µg	Experimental		Drug: CHF6001 3200µg
Placebo	Placebo Comparator		Drug: Placebo
Roflumilast	Active Comparator		Drug: Roflumilast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHF6001 1600µg	Drug	CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily	CHF6001 1600µg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.	Moderate or severe exacerbation is defined by symptomatic worsening of COPD: Moderate : requiring use of systemic corticosteroids (oral/IV/IM corticosteroids), and/or use of antibiotics Severe : requiring hospitalisation or resulting in death	Up to 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
The time to first moderate or severe exacerbation.	The time to first moderate or severe exacerbation.	Up to 52 weeks
The annual rate of severe exacerbations.	The annual rate of severe exacerbations.

Contacts/Locations Module

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases