None listed
Conditions
Interventions
Intervention1: Tulobuterol: 2mg once daily for 8 weeks
Control Intervention1: Salmeterol: 50microgram twice-a-day for 8 weeks.
Sponsors
Sparsha Pharma International Private Limited, India
Survey No. 354, Muppireddypally Village, Toopran Mandal, Medak Dist., A.P- 502334
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males or females aged >= 15 years at the time of giving informed consent. 2 Subjects 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. 3 Outpatients. 4 Non-smoker, Subjects who had been diagnosed as clinically stable asthma at least 6 months prior to Visit 1. 5 Subjects who meet both of the following criteria in terms of pulmonary function. o Has a mean morning PEF during the last 4 days prior to Visit 2 is >= 40% of the predicted value. o Has 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 6 Subjects who were able to keep the asthma & COPD diary correctly during the run-in period, in the investigator's/ subinvestigator's judgment. o Clinically stable COPD patients with FEV1 30 to 80% of the predicted value after inhalation of a short acting inhaled b2 agonist. 7 Subjects who were able to measure peak flows correctly during the run-in period, in the investigator's/subinvestigator's judgment.
Exclusion criteria
Exclusion criteria: 1 Subjects who have received injected steroids, injected ACTH, or oral steroids within four weeks of Visit1 or during run-in period. 2 Subjects 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. 3 Subjects 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. 4 Subjects with uncontrollable diabetes mellitus, hypertension, heart disease, or hyperthyroidism, who are inappropriate for this study in the judgement of the investigator/sub investigator. 5 Subjects who are unsuitable for this study in the judgment of the investigator/subinvestigator based on 12-lead ECG findings at Visit 1. 6 Subjects who are regularly using medications containing the following ingredients: Beta-blockers, alpha/beta-blockers 7 Subjects who have received immunosuppressive medications excluding Tacrolimus ointment. 8 Subjects who are receiving catecholamines. 9 Subjects with atopic dermatitis who are inappropriate for this study in the judgment of the investigator/subinvestigator. 10 Subjects who had or are suspected to have had hypersensitivity to any of the investigational products. 11 Subjects who received the last dose of other investigational drugs in the past 30 days. 12 Subject who are currently pregnant, possibly pregnant, lactating or willing to become pregnant during the study period. 13 Subjects who consume alcohol or drugs excessively the opinion of the investigator/subinvestigator. 14 Subjects who are judged by the investigator/subinvestigator to have Step 4 asthma (severe persistent) 15 Subjects who are judged by the investigator/ subinvestigator to be inappropriate for this study for any other reasons. 16 Females 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. 17 Hepatic dysfunction (AST/ALT/AlkPO4 >1.5 times upper limit of normal/ Bilirubin >1.5 times upper limit of normal (ULN)/ Known hepatic cirrhosis) 18 Renal dysfunction (any of the renal function tests >1.5 times upper limit of normal)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| &#61656; Efficacy: 1. Evening PEF 2. St George's Respiratory Questionnaire (SGRQ) score 3. Use of short acting beta agonist as rescue medication &#61656; Safety and Tolerability:Vital Signs: Pulse, Blood Pressure, Respiratory Function Examination (Ausculation) and Temperature RecordingsTimepoint: Screening, in-study, end-of-study | — |
Countries
India
Contacts
Public ContactDr. Dange Veerapaneni
Managing Director
Outcome results
None listed