Cysteamine for Asthma
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|ClinicalTrials.gov Identifier: NCT03883984|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Cysteamine Bitartrate Drug: Placebo Oral Tablet||Phase 1|
Asthma affects 25.7 million people in the US. Many people report symptoms despite taking high-doses of inhaled asthma medications. This difficult-to-treat group accounts for more than 50% of asthma related healthcare visits and hospitalizations. The purpose of this study is to see if a medicine called Cysteamine, given along with standard asthma care, will improve asthma symptoms and lung function.
This study is a double-blind, placebo-controlled, randomized trial of cysteamine. A placebo arm will be included to determine the comparative effectiveness of cysteamine in this population. Eligible participants will be assessed 1, 4 and 8 weeks post randomization and followed for an additional 4 weeks post treatment.
In order to enroll in this study, participants must be between the ages of 18-45 and have uncontrolled asthma.
This study will include 4 visits and weekly phone calls, and will be in the study for 3-4 months.
During the treatment period, participants will be placed in one of two treatment groups:
Participants will not be able to choose which group they are assigned. This assignment is random and by chance, much like flipping a coin. Participants will not know if they are receiving Cysteamine or placebo. Investigators will compare the study results between the participants of each group.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 randomized, double-blind, placebo-controlled trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cysteamine for Asthma|
|Actual Study Start Date :||June 18, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Cysteamine Bitartrate plus standard asthma care
Drug: Cysteamine Bitartrate
Cysteamine bitartrate administered four times per day (QID) for 8 weeks. 125mg tablet QID.
Placebo Comparator: Placebo Oral Tablet
Placebo plus standard asthma care
Drug: Placebo Oral Tablet
Placebo administered for 8 weeks. 125mg tablet QID.
- Change in the Asthma Symptom Severity Score [ Time Frame: Baseline (Pre-Treatment), V1 (4 weeks), V2 (8 weeks), Study End (4 weeks post-treatment, Follow-up Phone Call) ]Asthma symptom severity score will be classified using the Expert Panel Report 3 (EPR-3) criteria for untreated asthma. The level of impairment is based on the most severe indication of the following criteria: 1. Symptoms, 2. Nighttime awakenings, 3. Short-Acting Beta Agonist (SABA) use for symptom control, 4. Interference with normal activity, and 5. Lung Function.
- Number of Days with Albuterol Use Over Time [ Time Frame: Baseline (Pre-Treatment), V1 (4 weeks), V2 (8 weeks), Study End (4 weeks post-treatment, Follow-up Phone Call) ]Albuterol is a bronchodilator used as a rescue medication for treatment of asthma symptoms.
- Change in Inflammation in TH2 cells Over Time [ Time Frame: Baseline (Pre-Treatment), V1 (4 weeks), V2 (8 weeks, End Treatment) ]Inflammation as measured by T Helper Type 2 (TH2) cells in peripheral blood.
- Spirometry Measurement: Forced Expiratory Volume in 1 second (FEV1) Over Time [ Time Frame: Baseline (Pre-Treatment), V1 (4 weeks), V2 (8 weeks, End Treatment) ]FEV1 is the amount of air exhaled in 1 second during spirometry. This is used as a measurement of asthma severity.
- Peak Flow Measurement: Forced Expiratory Volume in 1 second (FEV1) Over Time [ Time Frame: Baseline (Pre-Treatment), V1 (4 weeks), V2 (8 weeks), Study End (4 weeks post-treatment, Follow-up Phone Call) ]FEV1 will be obtained by peak flow measurement. This will be used as a measurement in asthma severity.
- Peak Flow Measurement: Peak Expiratory Flow (PEF) Over Time [ Time Frame: Baseline (Pre-Treatment), V1 (4 weeks), V2 (8 weeks), Study End (4 weeks post-treatment, Follow-up Phone Call) ]PEF will be obtained by peak flow measurement. This will be used as a measurement in asthma severity.
- Change in Asthma Quality of Life Questionnaire (miniAQLQ) scores Over Time [ Time Frame: Baseline to Visit 2 (8 weeks) ]The miniAQLQ will be used to measure the impact that asthma has on participants quality of life. The miniAQLQ will ask questions in the following domains: symptoms, activity limitations, emotional function, and environmental stimuli. There are 15 questions, each with a 7-point scale. An answer of 1 on a question represents the greatest impairment possible and a 7 represents the least impairment. Individual questions are equally weighted. The overall miniAQLQ score is the mean of the responses to each of the 15 questions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883984
|Contact: Kristi Curtsinger, RN, BSN, BSfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Kristi Curtsinger, RN, BSN, BS 513-803-1651 email@example.com|
|Principal Investigator: Gurjit K Khurana Hershey, MD, PhD|
|Sub-Investigator: Jocelyn Biagini Myers, PhD|
|Principal Investigator:||Gurjit K Khurana Hershey, MD, PhD||Children's Hospital Medical Center, Cincinnati|