None listed
Conditions
Interventions
Intervention1: Submicron sized salbutamol sulphate dry powder inhalation (100 microgram): The test formulation is to be inhaled through normal rotahaler 2-4 times a day for 5-7 days or as directed by
Sponsors
Defence R&D Organisation
Eligibility
Inclusion criteria
Inclusion criteria: a) Healthy volunteers 1. Healthy Males/females, between 18-45 years ages group 2. On no permanent treatment 3. Suffering from no permanent / recurrent / chronic disease or disability b) Diseased subjects ? Worked up adult patients with pulmonary hypertension with associated mild or moderate asthma or COPD or ILD with hypoxemia or other disease conditions as mentioned. Wherever facilities are not available, for example at high altitude, clinical diagnosis shall be deemed sufficient as per accepted norms. Ventilation scan may be done where-ever possible to ascertain bioactive dose. 2. Age group: 18-70 years 3. Ambulatory, preferably admitted patients for better follow up. Non-critically ill patients.
Exclusion criteria
Exclusion criteria: a) Healthy volunteers 1. Those who do not sign the ICF 2. Those who refuse to abide by the rules/briefing 3. Those who have had any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial. 4. Patients who have received any other investigational drug for the last 1 month. 5. Too low or too high body weight (< 40 kg, > 100 kg). b) Diseased subjects 1. Patients with prior hypersensitivity to salbutamol 2. Patients who are unwilling to give informed consent. 3. Patients receiving inhalation of long acting beta-agonists within 1 week of the start of the study with persisting medical effect. 4. Patients with history of severe asthma / dyspnoea / poor inspirational capacity 5. Patients on continuous oxygen 6. Volunteers with serious or critical illness. 7. Patients who are pregnant, lactating or women of child bearing potential not using medically accepted methods of contraception. 8. Patients with clinically significant renal, respiratory (other than those mentioned), cardiac (including rheumatic or congenital heart disease), gastrointestinal, hepatic, endocrine or hematological disorders. 9. Patients who have any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial. 10. Patients who have received any other investigational drug for the last 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of short-term treatment with nano-salbutamol DPI in treatment of pulmonary hypertension and hypoxic hypoxemia due to different causes: a) Br asthma & COPD b) ILD & ARSD c) PHT primary, and related to other conditions including Rheumatic heart disease and Eisenmenger syndrome. d) High altitude conditions including PHT, non-acclimatization, AMS, HAPO 2. To evaluate the effect of short-term treatment nano-salbutamol DPI on blood oxygen, PFT and PHT parameters, improvement of cardiopulmonary performance and subjective relief Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of treatment with study medication on pulse oximetry, other parameters, symptomatology & patient acceptance 2. To evaluate the safety and tolerability of study medication 3. To generate further pharmacokinetic data of the drug and peak serum salbutamol sulphate levels upon inhalation of submicronic particulate material. 4. To evaluate the physicians and patients overall assessment of the effectiveness and tolerability of the study medication Timepoint: NIL | — |
Countries
India
Contacts
Public ContactAseem Bhatnagar
Institute of Nuclear Medicine & Allied Sciences, Defence R&D Organisation, Ministry of Defence
Outcome results
None listed