AMPLIFY
Research type
Research Study
Full title
A 24 week treatment, multicentre, randomised, double blinded, double dummy, parallel group, clinical trial evaluating the efficacy and safety of aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed-dose combination BID compared with each monotherapy (aclidinium bromide 400 μg BID and formoterol fumarate 12 μg BID) and tiotropium 18 μg QD when administered to patients with stable chronic obstructive pulmonary disease.
IRAS ID
200084
Contact name
Minal Kara
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-005444-33
Duration of Study in the UK
1 years, 2 months, 16 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a lung disease in the airways that carry air in and out of your lungs, making it difficult to breathe. COPD is a persistent condition that gets gradually worse over time. COPD is usually caused by smoking and the best way to slow the disease is to stop smoking.
Medications are used to ease the shortness of breath and cough. Some medications such as Aclidinium bromide can help reduce coughing by blocking the nerve signal that causes the cough. Medication such Formoterol fumarate is usually used for moderate and severe COPD patients to help reduce symptom burden and severity. They work by relaxing and dilating the airways and improve the passages of air into the lungs. Both medications have been approved and are available for doctors to prescribe in several countries across Europe and the United States for the maintenance treatment of COPD.
The purpose of this study is to see how effective the study medication aclidinium bromide combined with formoterol fumarate is in improving lung function in participants with stable moderate to very severe COPD if compared to therapy with individual components (aclidinium OR formoterol). Also it should be assessed whether aclidinium bromide has an equivalent effect in dilating the airways as tiotropium bromide.
This is a double-blinded, double-dummy study meaning that both the participant and the study doctor will not know which medication is being given. The study is randomised, meaning that participants will be randomly assigned to 1 of 4 treatment groups. About 20% of participants will be in Group 1 (combination of aclidinium and formoterol), 20% in Group 3 (formoterol) and 30% in Group 2(aclidinium) and Group 4 (tiotropium).
AstraZeneca is the sponsor of this study which will take place across worldwide. It is anticipated that approximately 1500 participants will be recruited.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0331
Date of REC Opinion
17 May 2016
REC opinion
Further Information Favourable Opinion