An observational study in Asthma, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by GlaxoSmithKline · Observational
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Among 261 studies in Asthma by GlaxoSmithKline — 7 open to participants now, 12 under way, 7 of them phase 3. Asthma · GlaxoSmithKline.
Among the 261 studies in Asthma by GlaxoSmithKline, this one is the 22nd largest by enrollment of the 24 observational ones that give a count, is one of 16 that started in 2017, is one of 24 observational ones, and was the 224th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →7 of the 261 studies in Asthma by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina, Canada and 1 more country
Ages 18+
GlaxoSmithKline · Sites in United States
Ages 12–80
GlaxoSmithKline · Sites in United States, Japan
Ages 12–80
GlaxoSmithKline · Sites in United States
Ages 6–11
GlaxoSmithKline · Sites in United States, United Kingdom
Ages 12+
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
261 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 63 · Phase 2 59 · Phase 3 61 · Phase 4 53
First in 1999; this study’s year is marked. 16 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below the median of 159 across 1,252 observational studies indexed under Asthma.
Median enrollment 100 across the 237 interventional studies, 512 across the 24 observational. Of the 239 that completed or were terminated, 131 (55%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
5 of the studies in Asthma by GlaxoSmithKline that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
| NCT07671001Phase 3GlaxoSmithKlineA Study of Depemokimab in Participants of 6 to 11 Years of Age | 2027-03-01 |
| NCT07712393GlaxoSmithKlineA Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283 | 2027-04-13 |
| NCT06433921GlaxoSmithKlineA Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | 2027-04-16 |
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Among the 261 studies in Asthma by GlaxoSmithKline, from their registry updates:
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Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory conditions involving the small airways with airflow limitations resulting from genetic and environmental interactions. Currently, there are no existing subject diaries with evidence of responsiveness to measure the daily symptoms of asthma. Therefore, there is a need to either develop a new symptom diary to characterize subject burden of asthma symptoms or modify/adapt an existing tool from a related disease area for use in subjects with moderate to severe asthma. The E-RS in COPD (E-RS: COPD®) questionnaire was developed as a measure of daily respiratory symptoms associated with COPD. The fixed dose combination of fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) administered via the ELLIPTA® dry powder inhaler (DPI) has been developed for the treatment of asthma. This cross-sectional, qualitative study is designed to understand the symptoms and disease experience of subjects with moderate to severe asthma. This study will also evaluate underlying concepts that are most important to asthmatic subjects compared to symptoms and concepts included in the E-RS: COPD and two supplemental asthma items (wheeze and shortness of breath with physical activity). Approximately 32 subjects will be included in the study and interviewed via telephone. Each interview including time for consent, qualitative interview, and completion of case report forms (CRFs) is expected to last approximately 60 to 90 minutes. Subjects will be expected to complete a daily diary for the next 7 days, following the initial telephone interview. E-RS: COPD and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
Approximately 32 subjects with moderate to severe asthma will be included in the study. Of these, approximately 25 will be English-speaking and 5-7 Spanish-speaking subjects. All subjects will be recruited from up to approximately 10 clinical sites in the United States and Canada.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with moderate to severe asthma will be interviewed via telephone. Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
Other: Telephonic interviews · Other: E-RS: COPD · Other: Supplemental asthma items · Other: Daily diary · Other: Sociodemographic questionnaire · Other: Clinical questionnaire
Qualitative concept elicitation telephone interviews will be conducted in subjects with asthma.
E-RS questionnaire will directly measure respiratory symptom severity.
Supplemental asthma items will include one question on wheeze and an item on breathlessness with activities to evaluate shortness of breath associated with strenuous activities.
Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
Sociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.
Clinical questionnaire will capture subject's clinical characteristics including the number of asthma exacerbations in the past 12 months, absenteeism due to asthma in the past month, and the presence of comorbid conditions.
Number of subjects attending semi-structured interview
A semi-structured interview guide will introduce and direct the discussion during the interview session. It will be used to elicit concepts of moderate to severe asthma symptoms and impacts as well as to assess the overall comprehension of the E-RS: COPD and supplemental asthma items. The interview guide is also designed to elicit from subjects how they used the provided response options to answer each item and provide them the opportunity to report if there are missing categories or if they could not respond to the item with the given response option.
Time frame: Up to 7 days
Number of subjects completing E-RS questionnaire in COPD
The E-RS: COPD questionnaire consists of 11 items from the 14 item exacerbations of COPD (EXACT-PRO) instrument. The 11-items will be scored on a 5-point scale ranging from "not at all" to "extreme". Items of the E-RS: COPD will capture information related to respiratory symptoms such as breathlessness, cough, sputum production, chest congestion, and chest tightness. The daily recording of information with the E-RS: COPD will allow assessment of underlying day-to-day variability of a subject's symptoms.
Time frame: Up to 7 days
Number of subjects completing supplemental asthma items
Two supplemental asthma items will be asked in conjunction with the E-RS: COPD questionnaire, including: a question on wheezing, a symptom of importance in asthma, and an item on breathlessness with activities to evaluate shortness of breath associated with strenuous activities.
Time frame: Up to 7 days
Number of subjects completing daily diary
Subjects will complete a paper-pen daily diary including the E-RS: COPD and supplemental asthma items for 7 days. Several questions related to the relevance of the E-RS: COPD and supplemental asthma items will be asked to subjects.
Time frame: Up to 7 days
Number of subjects completing sociodemographic questionnaire
The sociodemographic questionnaire is a brief, self-administered questionnaire, which includes items to capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment. Subjects will complete the sociodemographic questionnaire at the time of the interview.
Time frame: Up to 7 days
Number of subjects completing clinical questionnaire
The clinical questionnaire is a brief, self-administered questionnaire, which includes questions about the number of asthma exacerbations in the past 12 months, absenteeism due to asthma in the past month, and the presence of comorbid conditions. Subjects will complete the clinical questionnaire at the time of the interview.
Time frame: Up to 7 days
Time to diagnosis of asthma based on clinical data form
Clinicians will complete time to asthma diagnosis in clinical data form for each subject upon enrollment.
Time frame: Up to 7 days
Number of subjects with exacerbation history based on clinical data form
Clinicians will complete exacerbation history in clinical data form for each subject upon enrollment.
Time frame: Up to 7 days
Number of subjects with other health conditions based on clinical data form
Clinicians will complete information of any other health condition in clinical data form for each asthmatic subject upon enrollment.
Time frame: Up to 7 days
Number of subjects receiving maintenance therapy based on clinical data form
Clinicians will complete information of subjects receiving maintenance therapy in clinical data form.
Time frame: Up to 7 days
Ran from Dec 2017 to primary completion in Sep 2018, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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