COPD AsthmaNCT03275935
Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)
An observational study of COPD Asthma and Asthma-COPD Overlap Syndrome, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial summary
This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Asthma, Asthma-COPD Overlap Syndrome, Inhalation
- How many people
- 307 participants
- Where
- 1 siteNepal
- Study dates
- 1 Mar 2017to 30 Jun 2017
- How long will I take part?
- 1 Month
- 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: All patients presenting to Chest Clinic of Dhulikhel hospital, who were diagnosed of having either COPD, Asthma or Asthma-COPD Overlap Syndrome and are currently under inhalational bronchodilators in the form of Dry Powder Device (DPIs)
Who may be able to join
- Age >18 years,
- Diagnosed of having of asthma or COPD or ACOS
- Using dry powder inhaler therapy with Rotahaler
Who cannot join
- Use of inhaler devices other than Rotahaler
- Newly started on dry powdered inhalational therapy or patients who had recently received face-to-face training program on inhalation technique within the past one month
- Patients in acute exacerbation
- Patients failing to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Inhalation Technique in Patients With Chronic Obstructive Pulmonary Disease (COPD), Asthma or Asthma-COPD Overlap Syndrome(ACOS) Using a Dry Powder Device at Chest Clinic in Dhulikhel Hospital
This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.
Read the detailed description
This is a one group pretest- posttest design conducted in all patients presenting in Chest clinic of Dhulikhel Hospital-Kathmandu University Hospital, Nepal from March 2017 to May 2017. Patients diagnosed of having COPD, Asthma or Asthma-COPD Overlap Syndrome (ACOS) and were under inhalation bronchodilators in the form of Dry Powder Device via Rotahaler were included. Enrolled patients are assessed for inhalation technique compliance at their routine medical (pre-training) visits by physician. The use of inhaler device is evaluated in a practical manner by asking the patients to demonstrate their inhalation technique. After the assessment, instructions and training are given until they can use the device correctly. One month later (post-training), all patients are re-evaluated in regards to inhalation technique and subjective improvement of symptoms.
- Conditions
- COPD Asthma, Asthma-COPD Overlap Syndrome, Inhalation
- Keywords
- ACOS, Asthma, COPD, inhalation technique
- Medical subject headings
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Respiratory Aspiration, Asthma, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Training Arm | Patients that were given training in regards to proper inhalation technique of Rotahalers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 'Inhalation Scores" After a month from Baseline
An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7. After assessment, instructions were given with demonstrations regarding the correct use of Rotahaler. One month later (post-training visit), all patients were re-evaluated
Measured: After a month
Secondary outcomes (3)
Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.
Calculating the prevalence of the three medical conditions in Chest clinic of Dhulikhel Hospital
Measured: 3 months
Associated Factors for Incorrect Inhalation Technique
The potential associated factors for an incorrect inhalation technique to be calculated via univariable logistic regression analysis
Measured: 3 months
Prevalence of patients using the inhalation devices via incorrect technique
An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7.
Measured: At pretraining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Mar 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD AsthmaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sudeep Shrestha, Kathmandu University School of Medical Sciences
- Investigators
- Dr Sudeep Shrestha, MD, MRCP(UK), Principal investigator, Dhulikhel Hospital- Kathmandu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275935
- Sponsor's protocol ID
- 73/17
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 11 Sep 2017
- 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 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inhalation Technique in Patients With Chronic Obstructive Pulmonary Disease (COPD), Asthma or Asthma-COPD Overlap Syndrome(ACOS) Using a Dry Powder Device at Chest Clinic in Dhulikhel Hospital
- ClinicalTrials.gov ID
- NCT03275935
- Acronym / sponsor ID
- 73/17
- Conditions
- COPD Asthma, Asthma-COPD Overlap Syndrome, Inhalation
- Keywords
- ACOS, Asthma, COPD, inhalation technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 8 Sep 2017 (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.
This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.
Detailed description
This is a one group pretest- posttest design conducted in all patients presenting in Chest clinic of Dhulikhel Hospital-Kathmandu University Hospital, Nepal from March 2017 to May 2017. Patients diagnosed of having COPD, Asthma or Asthma-COPD Overlap Syndrome (ACOS) and were under inhalation bronchodilators in the form of Dry Powder Device via Rotahaler were included. Enrolled patients are assessed for inhalation technique compliance at their routine medical (pre-training) visits by physician. The use of inhaler device is evaluated in a practical manner by asking the patients to demonstrate their inhalation technique. After the assessment, instructions and training are given until they can use the device correctly. One month later (post-training), all patients are re-evaluated in regards to inhalation technique and subjective improvement of symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Arm | – | –Patients that were given training in regards to proper inhalation technique of Rotahalers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to Chest Clinic of Dhulikhel hospital, who were diagnosed of having either COPD, Asthma or Asthma-COPD Overlap Syndrome and are currently under inhalational bronchodilators in the form of Dry Powder Device (DPIs)
Key inclusion criteria (3 listed)
- Age >18 years,
- Diagnosed of having of asthma or COPD or ACOS
- Using dry powder inhaler therapy with Rotahaler
Key exclusion criteria (4 listed)
- Use of inhaler devices other than Rotahaler
- Newly started on dry powdered inhalational therapy or patients who had recently received face-to-face training program on inhalation technique within the past one month
- Patients in acute exacerbation
- Patients failing to give consent
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
Change in 'Inhalation Scores" After a month from Baseline
Time frame: After a month
An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7. After assessment, instructions were given with demonstrations regarding the correct use of Rotahaler. One month later (post-training visit), all patients were re-evaluated
3 secondary outcomes
Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.
Time frame: 3 months
Associated Factors for Incorrect Inhalation Technique
Time frame: 3 months
Prevalence of patients using the inhalation devices via incorrect technique
Time frame: At pretraining
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 11 Sep 2017.
- 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.
Dr Sudeep Shrestha, MD, MRCP(UK) principal investigator
Dhulikhel Hospital- Kathmandu University Hospital
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 COPD Asthma and Asthma-COPD Overlap Syndrome, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
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 3 inclusion and 4 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 11 Sep 2017. 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 Nepal. 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?
Change in 'Inhalation Scores" After a month from Baseline (time frame: After a month). 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 11 Sep 2017.