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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Emax | The maximum number of capsaicin evoked coughs | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Mild atopic asthmatics
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| Name | Affiliation | Role |
|---|---|---|
| Gail Gauvreau, PhD | Professor Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Cardio-Respiratory Research Lab | Hamilton | Ontario | L8N 3Z5 | Canada |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Dose response Curve | Changes in the capsaicin full dose response curves | 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) | 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |