A Phase IV Study of Tulobuterol Transdermal Patch in Patients with Asthma or COPD
- Conditions
- Asthma, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,
- Registration Number
- CTRI/2019/01/016974
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
**Aim and Objective:**
The aim of this clinical study is to investigate the efficacy, safety and tolerability of TuloplastTM (Tulobuterol transdermal patches- 0.5/1/2 mg) in patients with Asthma or Chronic Obstructive Pulmonary Disease (COPD).
**Primary Objective:**
The primary objective is to evaluate the safety and tolerability of TuloplastTM (Tulobuterol transdermal patches- 0.5/1/2 mg)
**Secondary Objective:**
The secondary objectives of this clinical study is to assess the efficacy of TuloplastTM (Tulobuterol transdermal patches- 0.5/1/2 mg) in improvement of lung function parameters and resolution of the clinical symptoms in patients with Asthma or COPD.
**Study Design:**
Prospective, Open label, Multicentric, Non-comparative clinical study.
**Estimated Sample Size**:
300 evaluable patients
**Test Product:**
TuloplastTM (Tulobuterol transdermal patches- 0.5 and 1 mg patches for pediatric asthma patients, and 2 mg patches for children above 9 years of age, adolescents and adult asthma or COPD patients)
**Study Duration:**
The study duration will be of 6 weeks [2 weeks run-in i.e. maintainence therapy with ICS alone + 4 weeks treatment with study medication] for pediatric, adolescent and adult asthma patients previously maintained on any other antiasthmatic agents. For COPD patients and asthma patients maintained on ICS alone the study duration will be of 4 weeks.
**Study Endpoints:**
Primary Outcomes:
- Proportion of patients reporting adverse events during the treatment period.
- Global assessment of TuloplastTM tolerability by investigators and patients using a 4-point scale (excellent, good, fair and poor)
- Proportion of patients requiring rescue medications
**Secondary Outcomes:**
- Percentage improvement in the severity of clinical symptoms from baseline of Asthma or COPD at the end of the study (as per GINA 2018 and GOLD 2018)
- Improvement in the lung function parameters (PEF, FEV1, FVC) at the end of the study (except in children less than 6 years of age who cannot perform spirometry)
- for children less than 6 years of age: reduction in airflow obstruction as interpreted from the parameters of impulse oscillometry (R5, R20, X5, Ax, Fres)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
- 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 β2 agonists is considered inappropriate) B.
- Asthma (Adolescent and Adult Patients)- 1.
- History of smoking during 6 months preceding enrollment 2.
- Patients with respiratory disease other than asthma (e.g., emphysema, bronchiectasis, pulmonary fibrosis, lung cancer, sarcoidosis) 5.
- Any existing pulmonary infection 6.
- Illness severe enough to require hospitalization 8.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (excellent, good, fair, and poor) -Throughout the study duration | -Last Visit (Day 28) | -Throughout the study duration -Proportion of patients requiring rescue medications -Throughout the study duration | -Last Visit (Day 28) | -Throughout the study duration -Global assessment of Tuloplastâ„¢ tolerability by investigators and patients using a 4-point scale -Throughout the study duration | -Last Visit (Day 28) | -Throughout the study duration -Proportion of patients reporting adverse events during the treatment period -Throughout the study duration | -Last Visit (Day 28) | -Throughout the study duration
- Secondary Outcome Measures
Name Time Method -Percentage improvement in the severity of clinical symptoms from baseline of Asthma or COPD at the end of the study (as per GINA 2018 and GOLD 2018) -Improvement in the lung function parameters (PEF, FEV1, FVC) at the end of the study (except in children 6 years of age who cannot perform spirometry)
Trial Locations
- Locations (7)
King George’s Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Government Medical College & Government General Hospital (Old RIMSGGH)
🇮🇳Srikakulam, ANDHRA PRADESH, India
Institute of Respiratory Disease, SMS Medical College
🇮🇳Jaipur, RAJASTHAN, India
Janta Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Lokmanya Tilak Municipal Medical College And General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Peerless Hospitex Hospital
🇮🇳Kolkata, WEST BENGAL, India
Vinaya Hospital And Research Centre
🇮🇳Kannada, KARNATAKA, India
King George’s Medical University🇮🇳Lucknow, UTTAR PRADESH, IndiaDr Sanjeev Kumar VermaPrincipal investigator9455934200drsanjeev78@gmail.com