ClinicalTrials.gg
CompletedNCT03425760COPVARUpdated Jun 29, 2018

A Cross-sectional Study of COPD and Symptom Variability in MEA Countries

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed. Per ClinicalTrials.gov, last updated 2018-06-29.

Sponsored by AstraZeneca · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,254
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.

Enrollment
25th of 89
3,254 · median 976
Started
2015
with 18 others
Observational
90 of 284
7 open now
Registered
215th of 284
by date

Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 25th largest by enrollment of the 89 observational ones that give a count, is one of 19 that started in 2015, is one of 90 observational ones, and was the 215th registered.

Pulmonary Disease, Chronic Obstructive

5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

14 of the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

9 more — sign in →

By country, each count listing its studies:

All 14 open studies →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.

It will also explore the current practice in management of stable GOLD C and D COPD patients.

Read the detailed description
  1. Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
  2. Secondary objectives:

    • To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
    • To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
    • To identify demographic, behavioral and clinical factors associated with symptoms variability.
03

Conditions studied

  • Chronic Obstructive Pulmonary Disease
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stable GOLD C or D COPD patient under maintenance treatment, over 45 years

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.

Inclusion criteria

  • Patients eligible for inclusion have to fulfill all of the following criteria:

    1. Stable GOLD C or D patient under maintenance treatment, over 45 years, who provided signed ;
    2. COPD diagnosis documented by spirometry performed in the past 12 months with an /FVC \< 0.7 and an FEV1 \< 50% predicted.

Exclusion criteria

Exclusion Criteria:

Patients are not eligible for inclusion if they meet one of the following criteria:

  1. Patient with an ongoing exacerbation*;
  2. Patient who has experienced an exacerbation* in the previous 3 months;
  3. History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
  4. Inability to understand the study related questions;
  5. Mentally disabled patient or unable to read and write;
  6. Pregnant.
  7. Current participation in a clinical trial;
Terms in these criteria, in plain language(3)

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,254 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients

    Mean score of Morning Activities and Symptoms Questionnaires (MASQ). MASQ is a patient-reported outcome instrument developed to measure morning activities and morning symptoms. The MASQ consist of two parts that captures instant symptoms through the Global Chest Symptoms Questionnaire (GCSQ), and morning activities through the Capacity of Daily Living during the morning (CDLM) questionnaire. Each item is rated on a 5 point Likert scale, from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions. Score Range a score ranging from 0 (so difficult that the activity could not be carried out by the patient on their own) to 5 (activity was not at all difficult to carry out).

    Time frame: 1 Year

  2. Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients

    Percentage of patients whose daily activities are affected as captured in the Chronic obstructive pulmonary disease(COPD) Assessment Test(CAT). CAT IS a questionnaire that assesses the impact of COPD (cough, sputum, dyspnoea, chest tightens) on health status. There are eight questions with a scale of 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The difference between stable and exacerbation patients was five units. No target score represents the best achievable outcome.

    Time frame: 1 Year

Secondary outcomes

  1. Current treatment practice for the management of COPD in Middle East Africa countries and their adherence to The Global Initiative for Chronic Obstructive Lung Disease(GOLD 2015) guidelines

    Patients whose treatment is adherent with The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2015 in Percentage

    Time frame: 1 Year

07

Study locations

No study locations are listed for this record.

08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2015 to primary completion in Mar 2017, 15 months.

Of 120 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's 15 months is below that.

Counting every sponsor, half of 587 studies reached it within 26 months; a quarter within 14 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Feb 8, 2018
StartActual
Dec 7, 2015
Primary completionActual
Mar 31, 2017
CompletionActual
Mar 31, 2017
Last update
Jun 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03425760
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Feb 8, 2018
Start date
Dec 7, 2015
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Jun 29, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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