A Phase IV Study of Tulobuterol Transdermal Patch in Patients with Asthma or COPD

Phase 4

Completed

• Conditions: Health Condition 1: J45- AsthmaHealth Condition 2: J449- Chronic obstructive pulmonary disease, unspecified

• Registration Number: CTRI/2019/01/016974
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-25
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

A. For Children < 6 years of age-

1. Children aged < 6 years or younger with a history of physician diagnosed asthma at the time of giving informed consent

2. Children experiencing more than one of the following symptoms: wheeze, cough, shortness of

breath, activity limitation and/or nocturnal awakening

3. Parents or guardians of the patients willing to give informed consent and willing to comply with the clinical study protocol

B. For Children > 6-11 years of age-

1. Children aged > 6 to 11 years with a history of physician diagnosed asthma at the time of giving informed consent

2. Children experiencing more than one of the following symptoms: wheeze, cough, shortness of

breath and/or nocturnal awakening

3. Children who meet one of the following criteria in terms of pulmonary function parameters:

i. The FEV1/FVC ratio less than 0.90

ii. Increase in FEV1 of > 12% predicted (post bronchodilator usage) from baseline, 10-15

minutes after 200-400 mcg salbutamol or equivalent as per GINA 2018

4. Parents or guardians of the patients willing to give written informed consent and willing to comply with the clinical study protocol

5. Children who give assent to participate in the study (Participants of appropriate intellectual maturity should personally sign and date a separately designed, written assent form. For other patients verbal assent is admissible)

C. Asthma (Adolescent and Adult Patients)-

1. Male or female patients aged = 12 years at the time of giving informed consent

2. Patients experiencing more than one of the following symptoms: wheeze, cough, chest tightness,shortness of breath and/or nocturnal awakening

3. Patients who meet one of the following criteria in terms of pulmonary function parameters:

i. FEV1/FVC: less than 0.75

ii. Bronchodilator reversibility: increase in FEV1 of >12% and >200mL from baseline, 10-15

minutes after 200-400 mcg salbutamol or equivalent

4. Patients whose asthma is not controlled by low dose Inhaled Corticosteroids (ICS) alone E.g. Budesonide (200-400 mcg)

5. Patients willing to give written informed consent (parents or guardians in case of adolescent patients; adolescent patients will have to sign an informed assent form) and willing to comply with the clinical study protocol

Exclusion Criteria

A. For children aged 6 months to 11 years-

1. Patients with a known history of hypersensitivity to the study medication

2. Patients with dermatological diseases, including atopic dermatitis

3. Patients showing evidences of pulmonary infection

4. Major organ disorders like liver or kidney failure

5. Patients with history of poorly controlled associated diseases such as: heart disease, hypertension,thyroid disorders and diabetes

6. Patients who are otherwise judged to be inappropriate for inclusion in the study by the investigator (for whom treatment with ß2 agonists is considered inappropriate)

B. Asthma (Adolescent and Adult Patients)-

1. History of smoking during 6 months preceding enrollment

2. Acute exacerbation of asthma (Patients can be included after stabilization)

3. Patients with dermatological diseases, including atopic dermatitis

4. Patients with respiratory disease other than asthma (e.g., emphysema, bronchiectasis, pulmonary fibrosis, lung cancer, sarcoidosis)

5. Any existing pulmonary infection

6. Female patients who are pregnant or breastfeeding or are planning to get pregnant within 2 months after initiation of the study

7. Illness severe enough to require hospitalization

8. Patients with a known history of hypersensitivity to the study medication

9. Major organ disorders like liver or kidney failure

10. Patients with history of poorly controlled associated diseases such as: heart disease, hypertension,thyroid disorders and diabetes

11. Patients who are otherwise judged to be inappropriate for inclusion in the study by the investigator (for whom treatment with ß2 agonists is considered inappropriate)

Study & Design

• Study Type: Interventional
• Study Design: Not specified