Clinical trial: Effect of Sex Hormone During the Menstrual Cycle on Capsaicin Evoked Cough Responses (NCT04233762)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects must be aged between 18 to 35 years

          2. Have a diagnosis of atopic asthma (based on at least one positive skin prick test and
             methacholine PC20 ≤16 mg/ml)

          3. FEV1 ≥ 70% of predicted

          4. Demonstrate a cough response to capsaicin with a minimum of 3 coughs during the
             screening capsaicin challenge

        Exclusion Criteria:

          1. Subjects who are in a pollen season that affects their asthma

          2. 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)

          3. Subjects who do not display evidence of airway hyper-responsiveness (methacholine
             PC20>16mg/ml) (assess after visit 1)

          4. Symptoms of upper respiratory tract infection in the last 1 month which have not
             resolved.

          5. Lower respiratory tract infection or pneumonia in the last 6 weeks.

          6. Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6
             months

          7. Asthma exacerbation in the previous month requiring a start of inhaled or oral
             corticosteroids.

          8. Any asthma medication with the exception of infrequent (less than twice weekly)
             short-acting β2-agonist.

          9. Subjects who have changed asthma medication within the past 4 weeks prior to screening

         10. A previous asthma exacerbation requiring Intensive Care Unit admission.

         11. Significant other primary pulmonary disorders in particularly; pulmonary embolism,
             pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis,
             emphysema or bronchiectasis.

         12. Pregnancy or breast-feeding

         13. Use of ACE inhibitors

         14. Any centrally acting medication (opioids, gapapentin, pregabalin, amitriptyline) which
             in the view of the investigator could alter the sensitivity of the cough reflex

         15. History of psychiatric illness, drug or alcohol abuse which may interfere in the
             participation of the trial.

         16. History of current or previous anabolic steroid use in men.

         17. 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

         18. For female's taking the oral contraceptive pill they must be taking this ≥6 months

         19. Use of B-blockers

         20. Patients with clinically significant cardiovascular disease

         21. Patients with known allergy to any of the study medications or excipients

         22. Patients with a known potentially life threatening allergy (e.g. food allergy,
             stinging insect allergy), history of anaphylaxis, mastocytosis, angioedema
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction