The SCALA Study will help researchers learn more about the study drug in people who have COPD with chronic bronchitis. The aim of the study is to find out more about the potential risks of the study drug (side effects) and whether it can improve symptoms of COPD. This study will also help researchers understand how the study drug acts in the body and how the body responds to it.
If you join the study, you will be asked to:
- Attend study visits at the study center, during which you will have different tests and assessments.
- Have your blood, urine, and mucus samples collected.
- Perform a simple breath test every morning and evening at home and record the results.
- Fill in a study diary at home.
You will be taking part in the SCALA Study for at least 36 weeks (about 8 months). For some participants, the study may last up to 64 weeks (about 15 months). The length of your participation will depend on when you join the study and when enough information about the study drug has been collected from everyone taking part.
Placebos are often compared with study drugs during clinical studies. Because a placebo does not contain any medicinally active ingredients, it should not have an effect on your condition.
Therefore, including a placebo group is the best way to help the study team:
- Better understand the effects (good or bad) of the study drug.
- Be as sure as possible that any effects (good or bad) are due to the study drug.
Using placebos in clinical studies is also often required by health authorities so that they can decide whether a study drug is well tolerated and works well enough to be made available to the wider public.
No, the study medication you receive will be decided at random by a computer. This process is called randomization. Neither you nor the study team will know which study medication you are receiving. This strategy, called blinding, ensures that results are handled fairly and not influenced by what you or the study team expect to happen.
During the study, you will continue taking your regular medication to manage your COPD. However, some COPD medications are not allowed before or during the study, so it may be necessary to switch these to a different type while in the study. As medication use can vary from person to person, the study team will go through all the medications you are taking, explain what you can continue, and let you know if any changes are required.
If for any reason you cannot attend a scheduled study visit, you can contact the study team to reschedule your visit. If you feel your COPD symptoms are not controlled during the study, you can use the rescue medication prescribed to you.
All studies involve risks and discomforts, including those from the study medication and study-related procedures. Some known risks and discomfort in this study include the following:
- Taking the study medication may cause side effects.
- In previous clinical studies of the study drug in participants with atopic dermatitis (eczema), the most common side effects were mild infections (influenza or cold-like symptoms such as runny nose and sore throat), headache, and redness where the injection is given.
- Where the injection is given, you may experience pain, swelling, itching, bleeding, bruising, and in some cases, blistering or infection.
- Blood draws may cause pain, bruising, or dizziness.
- The inflatable cuff used to measure your blood pressure may cause mild discomfort in your arm.
- The electrocardiogram (ECG) may cause discomfort from the sticky pads placed on your skin.
- The spirometry test to measure your lung function may make you feel dizzy, faint, shaky, sick, or tired for a short time afterwards.
- The high-resolution computed tomography (HRCT) scan will expose you to a low level of radiation – about the same amount you’d receive from the sun over 18 months.
A more comprehensive list of known side effects of the study drug can be found in your Informed Consent Form, which will be given to you before you decide whether to join the study.
If any side effects occur, the study team will monitor you and provide treatment to minimize any discomfort. While you are encouraged to tell your regular doctor that you are participating in this study, your study team will treat you for any side effects that may occur during your participation. You will also be covered by insurance against any study-related injury.
During the study, you will be asked to complete an electronic diary twice every day on a smartphone or an electronic tablet. If you don’t have a suitable device, the study team will provide one to use during the study. You can also complete the electronic diary via a web browser on a laptop or desktop computer. In the electronic diary, you will record your lung function and information about medications you take for COPD.
During the study, data will be collected on your lung function at regular intervals. To do this, the study team will provide you with a peak flow meter – a small, handheld device that measures how fast you can exhale air from your lungs. You will be asked to record this data in your electronic diary.
You will not have to pay for the study medication or any study-related tests or care. The cost of any other drugs or medical procedures outside of this study will not be covered. The study team will explain which activities are part of the study and which are part of your usual medical care.
You will not receive payment for your participation, but reasonable travel and meal expenses may be reimbursed. Travel assistance may be offered for you and anyone accompanying you to the study visits.
Taking part in the SCALA Study is completely voluntary. You are free to leave the study at any time and for any reason, without penalty. If you withdraw early from the study, you will be asked to visit the study center for an Early Discontinuation Visit to check on your health and well-being.
If you stop receiving study medication early and you agree, early discontinuation follow-up phone calls will be conducted every month until you reach your planned end of the study, or until the study itself ends. No study procedures will be performed. During these phone calls, you will be asked about any changes in your health and medication(s) you are or have been taking.
More information about this clinical study is available in the ClinicalTrials.gov database (English-language only).
SCALA is a Latin word that means ladder or staircase and is also a symbol for climbing and ascent. It was chosen as the name for the SCALA Study to signify that people with COPD can struggle with physical activities in their daily lives.
The SCALA Study is sponsored by UCB, a global biopharma company based in Belgium.
All of your personal data collected for the study will be “coded” to remove any part of the personal data that could identify you. Using a code to identify you helps researchers keep your information confidential.
The overall results of this study will be available on ClinicalTrials.gov after all participants have left the study, all study data have been analyzed, and the final study report has been written. A summary of the results in plain language will be shared on the UCB website, but please note that it could take years until this is available. The study sponsor, UCB, may publish the results in an academic journal, but it will not include any information that can identify individual study participants.