Asthma ChronicCOVID-19NCT04613245
Health-Related Quality of Life of Patients With Asthma During the Pandemic of COVID-19
An observational study of Asthma Chronic and Bronchial Asthma, run by Cairo University at 1 site in Egypt.
Trial summary
Nowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Chronic, Bronchial Asthma
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2020to 17 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study participants will be adults who have been diagnosed with bronchial asthma or pulmonary disease.
Who may be able to join
- Participant's age: 18 years or older
- medically diagnosed with bronchial asthma
Who cannot join
- not medically diagnosed with asthma by a physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-Related Quality of Life of Patients With Asthma and Its Associated Factors During the Pandemic of COVID-19
Nowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Depression was significantly associated with asthma interference with daily activities, breathlessness, night symptoms, use of bronchodilators, and poor compliance with medical treatment.
Covid-19 pandemic induced the countries around the world to require from its citizens not to ask for health care support rather than in emergency situations and through utilizing telemedicine. This action aims to control spreading the infection with viruses as well as to reduce the workload on the healthcare providers.
Read more
Although asthma is not listed as one of the chronic conditions that might complicate coronavirus infections, asthma people might have a high-stress level that might induce their asthma attack which consequentially reflects on their quality of life. People with asthma have a unique experience rather than people with other health conditions during COVID-19.
Patients with asthma experience a lot of stressors that might induce asthma and impaired their HRQOL such as overuse of antiseptic substances, stay home with a sedentary lifestyle, the sudden shift to telemedicine, and electronic work from home. Also, as a result of the similarity of asthma symptoms with coronavirus symptoms, the patient might have a continuous sense of uncertainty that s/he is infected with the COVID-19 virus, and this suspicion can increase the psychological overburden on these patients.
Therefore, all these stressors should be evaluated to recognize their health needs and the kind of social and health support that should be provided to them during the pandemic time. Also, Identifying the predictors of HRQOL among patients with asthma during the pandemic of COVID-19 is urgently required.
Read the detailed description
Asthma is a chronic inflammatory disease of the lower respiratory tract which derives from a combination of genetic predisposition with environmental exposure to several factors. It is a chronic respiratory disease that results in morbidity, mortality, and impaired health-related quality of life (HRQoL). It is estimated that 334 million people have asthma worldwide.
Nowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Depression was significantly associated with asthma interference with daily activities, breathlessness, night symptoms, use of bronchodilators, and poor compliance with medical treatment.
Covid-19 pandemic induced the countries around the world to require from its citizens not to ask for health care support rather than in emergency situations and through utilizing telemedicine. This action aims to control spreading the infection with viruses as well as to reduce the workload on the healthcare providers.
Although asthma is not listed as one of the chronic conditions that might complicate coronavirus infections, asthma people might have a high-stress level that might induce their asthma attack which consequentially reflects on their quality of life. People with asthma have a unique experience rather than people with other health conditions during COVID-19.
Patients with asthma experience a lot of stressors that might induce asthma and impaired their HRQOL such as overuse of antiseptic substances, stay home with a sedentary lifestyle, the sudden shift to telemedicine, and electronic work from home. Also, as a result of the similarity of asthma symptoms with coronavirus symptoms, the patient might have a continuous sense of uncertainty that s/he is infected with the COVID-19 virus, and this suspicion can increase the psychological overburden on these patients.
Therefore, all these stressors should be evaluated to recognize their health needs and the kind of social and health support that should be provided to them during the pandemic time. Also, Identifying the predictors of HRQOL among patients with asthma during the pandemic of COVID-19 is urgently required.
A cross-sectional analytical design will be utilized.
The study participants will be adults (18 years or older) who have been diagnosed with bronchial asthma or pulmonary disease.
- Conditions
- Asthma Chronic, Bronchial Asthma
- Keywords
- Quality of life, Health related quality of life, patient reported outcome, Asthma, COVID-19
- Medical subject headings
- Asthma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire (ACQ)
ACQ has a multidimensional construct assessing symptoms (5 items--self-administered) and rescue in bronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff, but it will not be applied in the current study as it will be difficult to be self-reported by the participants. 7-point scale (0=no impairment, 6= maximum impairment for symptoms. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measured: One week
Secondary outcomes (1)
Mini Asthma Quality of Life Questionnaire
The MiniAQLQ will be utilized to investigate the HRQoL of the participants. The Mini AQLQ-S has 15 questions that gives an overall summary index and four domains: activity limitation, symptoms, emotional function, and environmental stimuli. The questions all refer to the "last two weeks" and use seven Likert-type response options e.g., seven response options ranging from "all of the time" to "none of the time".
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start21 Jul 2020
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChronicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Fathy Afifi Youssef, Cairo University
- Investigators
- Naglaa FA Youssef, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613245
- Sponsor's protocol ID
- Serial 39-2020
- Acronym
- COVID-19
- Status last verified
- Feb 2026
- First submitted
- 29 Oct 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life of Patients With Asthma and Its Associated Factors During the Pandemic of COVID-19
- ClinicalTrials.gov ID
- NCT04613245
- Acronym / sponsor ID
- COVID-19 / Serial 39-2020
- Conditions
- Asthma Chronic, Bronchial Asthma
- Keywords
- Quality of life, Health related quality of life, patient reported outcome, Asthma, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Depression was significantly associated with asthma interference with daily activities, breathlessness, night symptoms, use of bronchodilators, and poor compliance with medical treatment.
Covid-19 pandemic induced the countries around the world to require from its citizens not to ask for health care support rather than in emergency situations and through utilizing telemedicine. This action aims to control spreading the infection with viruses as well as to reduce the workload on the healthcare providers.
Although asthma is not listed as one of the chronic conditions that might complicate coronavirus infections, asthma people might have a high-stress level that might induce their asthma attack which consequentially reflects on their quality of life. People with asthma have a unique experience rather than people with other health conditions during COVID-19.
Patients with asthma experience a lot of stressors that might induce asthma and impaired their HRQOL such as overuse of antiseptic substances, stay home with a sedentary lifestyle, the sudden shift to telemedicine, and electronic work from home. Also, as a result of the similarity of asthma symptoms with coronavirus symptoms, the patient might have a continuous sense of uncertainty that s/he is infected with the COVID-19 virus, and this suspicion can increase the psychological overburden on these patients.
Therefore, all these stressors should be evaluated to recognize their health needs and the kind of social and health support that should be provided to them during the pandemic time. Also, Identifying the predictors of HRQOL among patients with asthma during the pandemic of COVID-19 is urgently required.
Detailed description
Asthma is a chronic inflammatory disease of the lower respiratory tract which derives from a combination of genetic predisposition with environmental exposure to several factors. It is a chronic respiratory disease that results in morbidity, mortality, and impaired health-related quality of life (HRQoL). It is estimated that 334 million people have asthma worldwide.
Nowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Depression was significantly associated with asthma interference with daily activities, breathlessness, night symptoms, use of bronchodilators, and poor compliance with medical treatment.
Covid-19 pandemic induced the countries around the world to require from its citizens not to ask for health care support rather than in emergency situations and through utilizing telemedicine. This action aims to control spreading the infection with viruses as well as to reduce the workload on the healthcare providers.
Although asthma is not listed as one of the chronic conditions that might complicate coronavirus infections, asthma people might have a high-stress level that might induce their asthma attack which consequentially reflects on their quality of life. People with asthma have a unique experience rather than people with other health conditions during COVID-19.
Patients with asthma experience a lot of stressors that might induce asthma and impaired their HRQOL such as overuse of antiseptic substances, stay home with a sedentary lifestyle, the sudden shift to telemedicine, and electronic work from home. Also, as a result of the similarity of asthma symptoms with coronavirus symptoms, the patient might have a continuous sense of uncertainty that s/he is infected with the COVID-19 virus, and this suspicion can increase the psychological overburden on these patients.
Therefore, all these stressors should be evaluated to recognize their health needs and the kind of social and health support that should be provided to them during the pandemic time. Also, Identifying the predictors of HRQOL among patients with asthma during the pandemic of COVID-19 is urgently required.
A cross-sectional analytical design will be utilized.
The study participants will be adults (18 years or older) who have been diagnosed with bronchial asthma or pulmonary disease.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with asthma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study participants will be adults who have been diagnosed with bronchial asthma or pulmonary disease.
Key inclusion criteria (2 listed)
- Participant's age: 18 years or older
- medically diagnosed with bronchial asthma
Key exclusion criteria (1 listed)
- not medically diagnosed with asthma by a physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma Control Questionnaire (ACQ)
Time frame: One week
ACQ has a multidimensional construct assessing symptoms (5 items--self-administered) and rescue in bronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff, but it will not be applied in the current study as it will be difficult to be self-reported by the participants. 7-point scale (0=no impairment, 6= maximum impairment for symptoms. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
1 secondary outcome
Mini Asthma Quality of Life Questionnaire
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naglaa FA Youssef, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Chronic and Bronchial Asthma, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire (ACQ) (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.