A Cross-sectional Study to Measure Cough in Severe Asthma
Asthma · Cough
Bottom Line
View on ClinicalTrials.gov: NCT03999203 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Citric acid (Drug); Leicester Cough monitor (Device); fractional exhaled nitric oxide testing (FeNO) (Other); Patient reported outcome measures (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen's University, Belfast
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cough Frequency Measurement |
6.6; 2.7; 2.5; 12.7 | — |
| PRIMARY Cough Reflex Sensitivity (Citric Acid Cough Challenge) |
0.125; 0.25; 0.139; 0.125 | — |
| SECONDARY Asthma Control Questionnaire |
1.9; 1.9; 0.6; 1.9 | — |
| SECONDARY Asthma Quality of Life Questionnaire |
4.5; 4.8; 5.9; 4.7 | — |
| SECONDARY Leceister Cough Questionnaire |
15.2; 18.7; 20; 14.2 | — |
| SECONDARY Cough Quality of Life Questionnaire |
61; 57; 37; 56.5 | — |
| SECONDARY Fractional Exhaled Nitric Oxide (FeNO) |
47; 9.5; 19; 19 | — |
| SECONDARY Blood Eosinophil Count |
420; 120; 260; 190 | — |
Summary
Eligibility Criteria
Inclusion Criteria (Severe Asthmatics):
- Ability and willingness to comply with the study procedures
- Age ≥18 to ≤75 years at the time of informed consent
- Severe asthma (as defined by GINA step 4/5 classification of asthma severity) after a detailed systematic assessment
- History of asthma treatment with high doses of Inhaled Corticosteroids (≥1000 µg beclomethasone dipropionate daily, or equivalent) and an additional controller
- Three patient groups with severe asthma will be investigated in the study and will be defined as follows:
T2-High Severe Asthmatics (Group A)
- Persistent blood eosinophil count ≥0.3x10^9/mL and
- Persistent high FeNO levels ≥30 ppb and
- Adherence to inhaled and oral corticosteroid therapy
T2-Low Severe Asthmatics (Group B)
- Persistent blood eosinophil count ≤0.2x10^9/Ml and
- Persistent low FeNO levels ( 15 pack-years A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or pipe or cigar) for ≥30 days within the 24 months before the time of informed consent and for whom cotinine testing is positive.
A former smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or pipe or cigar) for ≥30 days in his or her lifetime (as long as the 30-day total did not include the 24 months before the time of informed consent) and for whom cotinine testing is negative.
A pack-year is defined as the average number of packs per day times the number of years of smoking.
- Initiation of or change in allergen immunotherapy within three months before the time of informed consent
- Treatment with an investigational agent within 30 days of informed consent or 5 half-lives of the investigational agent, whichever is longer
- Female patients who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT03999203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.