AsthmaCASHNCT04233762
Effect of Sex Hormone During the Menstrual Cycle on Capsaicin Evoked Cough Responses
An observational study of Asthma, run by McMaster University at 1 site in Canada.
Trial summary
The study aim is to investigate if changes in sex hormones during the menstrual cycle affects cough sensitivity in females and males with mild allergic asthma. Female subjects will be grouped according to natural cycle, or taking oral contraceptives. Male subjects will act as the control group. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Asthma
- Type of treatment
- Pill or oral medicine
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2020to 30 May 2022
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Mild atopic asthmatics
Who may be able to join
- Subjects must be aged between 18 to 35 years
- Have a diagnosis of atopic asthma (based on at least one positive skin prick test and methacholine PC20 ≤16 mg/ml)
- FEV1 ≥ 70% of predicted
- Demonstrate a cough response to capsaicin with a minimum of 3 coughs during the screening capsaicin challenge
Who cannot join
- Subjects who are in a pollen season that affects their asthma
- Subjects who report allergies to capsaicin or bronchoconstrict at the end of the full dose capsaicin cough challenge and require short acting bronchodilator therapy (assess after visit 1)
- Subjects who do not display evidence of airway hyper-responsiveness (methacholine PC20>16mg/ml) (assess after visit 1)
- Symptoms of upper respiratory tract infection in the last 1 month which have not resolved.
- Lower respiratory tract infection or pneumonia in the last 6 weeks.
- Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6 months
Show all 22Show fewer
- Asthma exacerbation in the previous month requiring a start of inhaled or oral corticosteroids.
- Any asthma medication with the exception of infrequent (less than twice weekly) short-acting β2-agonist.
- Subjects who have changed asthma medication within the past 4 weeks prior to screening
- A previous asthma exacerbation requiring Intensive Care Unit admission.
- Significant other primary pulmonary disorders in particularly; pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis.
- Pregnancy or breast-feeding
- Use of ACE inhibitors
- Any centrally acting medication (opioids, gapapentin, pregabalin, amitriptyline) which in the view of the investigator could alter the sensitivity of the cough reflex
- History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
- History of current or previous anabolic steroid use in men.
- For the natural cycle group, the female patients must have regular (24 to 35 day) natural cycles and no oral contraceptive use for ≥6 months
- For female's taking the oral contraceptive pill they must be taking this ≥6 months
- Use of B-blockers
- Patients with clinically significant cardiovascular disease
- Patients with known allergy to any of the study medications or excipients
- Patients with a known potentially life threatening allergy (e.g. food allergy, stinging insect allergy), history of anaphylaxis, mastocytosis, angioedema
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Cardio-Respiratory Research Lab
Hamilton, Ontario, L8N 3Z5
About this study
Official title: The Effect of Sex Hormone Levels During the Menstrual Cycle on Capsaicin Evoked Cough
The study aim is to investigate if changes in sex hormones during the menstrual cycle affects cough sensitivity in females and males with mild allergic asthma. Female subjects will be grouped according to natural cycle, or taking oral contraceptives. Male subjects will act as the control group.
Read the detailed description
The study will have a total of 3 visits separated by at least 24 hours. Screening Period (Visits 1) - For All Subjects. Eligible subjects will be identified during the initial screening procedures with measures of spirometry, hyperresponsiveness to methacholine, complete history, physical examination, allergen skin test, and capsaicin cough challenge. For female subjects, this visit will occur during Day 1-5 (follicular phase) of the menstrual cycle. Subjects meeting the eligibility criteria will be randomized to Sequence A or Sequence B.
Sequence A will require Visit 2 to occur during menstrual cycle days 1-5 (follicular phase) and Visit 3 to occur during menstrual cycle days 21 - 25 (luteal phase).
Sequence B will require Visit 2 to occur during menstrual cycle days 21-25 (luteal phase) and Visit 3 to occur during menstrual cycle days 1 - 5 (follicular phase).
During Visit 2 and 3 subjects will undergo measures of spirometry, hyperresponsiveness to methacholine, capsaicin cough challenge, allergen skin test, sputum and blood collection.
Visit Windows Each visit must be separated by a minimum of 24 hours. Study visits can be performed in the morning or afternoon, however for each subject the timing should be consistent with Visit 1 at the same time of day ± 2 hours.
- Conditions
- Asthma
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Female Natural Cycle Group | Females with regular natural menstrual cycle. | |
| Female Oral Contraceptive Pill Group | Females taking the combined oral contraceptive pill. | |
| Male Group | Males with no history of anabolic steroid use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emax
The maximum number of capsaicin evoked coughs
Measured: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
Secondary outcomes (3)
ED 50
The dose of capsaicin that evokes at least half the maximum number of coughs(ED50) in days 1 -5 and 21 - 25 of the natural cycle, and between the natural cycle, male subjects and female subjects taking the oral contraceptive pill
Measured: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
Dose response Curve
Changes in the capsaicin full dose response curves
Measured: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
C2 and C5
Changes in the dose of capsaicin causing 2 coughs (C2) and 5 coughs (C5)
Measured: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start8 Jan 2020
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gail Gauvreau, PhD, Principal investigator, Professor Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233762
- Sponsor's protocol ID
- McMaster-CASH
- Acronym
- CASH
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sex Hormone Levels During the Menstrual Cycle on Capsaicin Evoked Cough
- ClinicalTrials.gov ID
- NCT04233762
- Acronym / sponsor ID
- CASH / McMaster-CASH
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 18 Jan 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.
The study aim is to investigate if changes in sex hormones during the menstrual cycle affects cough sensitivity in females and males with mild allergic asthma. Female subjects will be grouped according to natural cycle, or taking oral contraceptives. Male subjects will act as the control group.
Detailed description
The study will have a total of 3 visits separated by at least 24 hours. Screening Period (Visits 1) - For All Subjects. Eligible subjects will be identified during the initial screening procedures with measures of spirometry, hyperresponsiveness to methacholine, complete history, physical examination, allergen skin test, and capsaicin cough challenge. For female subjects, this visit will occur during Day 1-5 (follicular phase) of the menstrual cycle. Subjects meeting the eligibility criteria will be randomized to Sequence A or Sequence B.
Sequence A will require Visit 2 to occur during menstrual cycle days 1-5 (follicular phase) and Visit 3 to occur during menstrual cycle days 21 - 25 (luteal phase).
Sequence B will require Visit 2 to occur during menstrual cycle days 21-25 (luteal phase) and Visit 3 to occur during menstrual cycle days 1 - 5 (follicular phase).
During Visit 2 and 3 subjects will undergo measures of spirometry, hyperresponsiveness to methacholine, capsaicin cough challenge, allergen skin test, sputum and blood collection.
Visit Windows Each visit must be separated by a minimum of 24 hours. Study visits can be performed in the morning or afternoon, however for each subject the timing should be consistent with Visit 1 at the same time of day ± 2 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Female Natural Cycle Group | – | –Females with regular natural menstrual cycle. |
| Female Oral Contraceptive Pill Group | – | –Females taking the combined oral contraceptive pill. |
| Male Group | – | –Males with no history of anabolic steroid use. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mild atopic asthmatics
Key inclusion criteria (4 listed)
- Subjects must be aged between 18 to 35 years
- Have a diagnosis of atopic asthma (based on at least one positive skin prick test and methacholine PC20 ≤16 mg/ml)
- FEV1 ≥ 70% of predicted
- Demonstrate a cough response to capsaicin with a minimum of 3 coughs during the screening capsaicin challenge
Key exclusion criteria (22 listed)
- Subjects who are in a pollen season that affects their asthma
- Subjects who report allergies to capsaicin or bronchoconstrict at the end of the full dose capsaicin cough challenge and require short acting bronchodilator therapy (assess after visit 1)
- Subjects who do not display evidence of airway hyper-responsiveness (methacholine PC20>16mg/ml) (assess after visit 1)
- Symptoms of upper respiratory tract infection in the last 1 month which have not resolved.
- Lower respiratory tract infection or pneumonia in the last 6 weeks.
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
Emax
Time frame: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
The maximum number of capsaicin evoked coughs
3 secondary outcomes
ED 50
Time frame: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
Dose response Curve
Time frame: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
C2 and C5
Time frame: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle
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 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Gail Gauvreau, PhD principal investigator
Professor Department of Medicine
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, run by McMaster University at 1 site in Canada.
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 4 inclusion and 22 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 1 Mar 2024. 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 Canada. 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?
Emax (time frame: One visit during day 1 to day 5 of the menstrual cycle, compared to one visit during day 21 to 25 of the menstrual cycle). 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 1 Mar 2024.