To evaluate efficacy and tolerability of transdermal tulobuterol in indian patients of clinically stable bronchial asthma and COPD
- Registration Number
- CTRI/2011/091/000088
- Lead Sponsor
- Sparsha Pharma International Private Limited, IndiaSurvey No. 354, Muppireddypally Village, Toopran Mandal, Medak Dist., A.P- 502334
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
1Males or females aged >= 15 years at the time of giving informed consent.
2Subjects who are able to give a written informed consent to participation in the study. However, if a subject is aged < 20 years at the time of giving informed consent, a written informed consent should be obtained from the subject and his/her legally acceptable representative.
3Outpatients.
4Non-smoker, Subjects who had been diagnosed as clinically stable asthma at least 6 months prior to Visit 1.
5Subjects who meet both of the following criteria in terms of pulmonary function.
oHas a mean morning PEF during the last 4 days prior to Visit 2 is >= 40% of the predicted value.
oHas at least 2 days with a diurnal variation in PEF of >= 15% during the run-in period, or had been confirmed and recorded reversibility of >= 15% using rapid-acting inhaled beta2 agonists within 3 months prior to Visit 1
6Subjects who were able to keep the asthma & COPD diary correctly during the run-in period, in the investigator's/ subinvestigator's judgment.
oClinically stable COPD patients with FEV1 30 to 80% of the predicted value after inhalation of a short acting inhaled b2 agonist.
7Subjects who were able to measure peak flows correctly during the run-in period, in the investigator's/subinvestigator's judgment.
1Subjects who have received injected steroids, injected ACTH, or oral steroids within four weeks of Visit1 or during run-in period.
2Subjects who have received xanthines (oral, injected, suppository), beta2 agonists other than rescue medication (rapid-acting inhaled beta2 agonists), or inhaled anti-cholinergics during the run-in period.
3Subjects with respiratory disease other than asthma & COPD (e.g., pulmonary fibrosis, lung cancer, sarcoidosis, and old tuberculosis) which, in the judgment of the investigator/subinvestigator, are likely to affect efficacy evaluation.
4Subjects with uncontrollable diabetes mellitus, hypertension, heart disease, or hyperthyroidism, who are inappropriate for this study in the judgement of the investigator/sub investigator.
5Subjects who are unsuitable for this study in the judgment of the investigator/subinvestigator based on 12-lead ECG findings at Visit 1.
6Subjects who are regularly using medications containing the following ingredients: Beta-blockers, alpha/beta-blockers
7Subjects who have received immunosuppressive medications excluding Tacrolimus ointment.
8Subjects who are receiving catecholamines.
9Subjects with atopic dermatitis who are inappropriate for this study in the judgment of the investigator/subinvestigator.
10Subjects who had or are suspected to have had hypersensitivity to any of the investigational products.
11Subjects who received the last dose of other investigational drugs in the past 30 days.
12Subject who are currently pregnant, possibly pregnant, lactating or willing to become pregnant during the study period.
13Subjects who consume alcohol or drugs excessively the opinion of the investigator/subinvestigator.
14Subjects who are judged by the investigator/subinvestigator to have Step 4 asthma (severe persistent)
15Subjects who are judged by the investigator/ subinvestigator to be inappropriate for this study for any other reasons.
16Females with childbearing potential must have a negative pregnancy test before and immediately after the study period. Sexually active females must use an effective method of contraception for the duration of the study or permanently sterilized. Contraception methods include oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant®), medroxyprogesteron acetate injections (Depo-provera®) or contraceptive foam with condom.
17Hepatic dysfunction (AST/ALT/AlkPO4 >1.5 times upper limit of normal/ Bilirubin >1.5 times upper limit of normal (ULN)/ Known hepatic cirrhosis)
18Renal dysfunction (any of the renal function tests >1.5 times upper limit of normal)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the efficacy (non-inferiority) of transdermal tulobuterol 2mg once a day, compared with Salmeterol 50mcg bid (100mcg/day), in terms of improvement in morning peak expiratory flow (PEF) rate.Timepoint: Screening, Week 4 and end-of-study
- Secondary Outcome Measures
Name Time Method &#61656;Efficacy:<br>1.Evening PEF<br>2.St George's Respiratory Questionnaire (SGRQ) score<br>3.Use of short acting beta agonist as rescue medication<br>&#61656;Safety and Tolerability:Vital Signs: Pulse, Blood Pressure, Respiratory Function Examination (Ausculation) and Temperature RecordingsTimepoint: Screening, in-study, end-of-study